Effects of a Multimodal Program of Therapeutic Exercise and Functional Recovery With Follow-up in the Elderly After Hip Fracture Surgery Using a Digital Application. Observational Study.
Conditions: Hip Fractures
Sponsor: Zamar Fisioterapia

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
 
 
RESEARCH PROJECT APPLICATION REPORT 
 
Title of the Project: Effects of a Multimodal Program of Therapeutic Exercise and 
Functional Recovery With Follow-up in the Elderly After Hip Fracture Surgery Using a 
Digital Application. Observational Study.   
(Code P-2020_007_v1). 
Date: March 25th, 2021 
 
Principal Investigator's identification details 
Surname, first name: Zambrano Martín, Joaquín 
Professional category: Physiotherapist 
Email: jzambrano@nebrija.es 
Institution: Centro Universitario San Rafael Nebrija, Doctoral Programme in Health, 
Disability, Dependence and Welfare. International Doctoral School (EIDUM), University 
of Murcia. 
 
Collaborating researchers: 
• 
Surname, first name: Gómez Conesa, Antonia. 
Institution: University of Murcia. 
• 
Surname, first name: Mendoza Puente, Miguel 
Institution: Centro Universitario San Rafael Nebrija. 
• 
Surname, first name:Méndez Sánchez, Roberto 
Institution to which it belongs: University of Salamanca. 
• 
Surname, first name: Chana Valero, Pedro 
Institution: Centro Universitario San Rafael Nebrija. 
• 
Surname, first name: García García, Elena 
Institution to which it belongs: Fundación San Juan de Dios, Centro Universitario 
de CC de la Salud San Rafael Nebrija. 
• 
Surname, first name: Saldaña Díaz, Andrés 
Institution to which he belongs: Hospital San Juan de Dios de León. 
 
 
Project type: Individual ☒ Coordinated ☐ 
Multicentre ☐ 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
 
 
SUMMARY 
Background 
In recent years, Western populations have experienced an increase in life expectancy 
and therefore an ageing population. This has led to an increase in the number of low-
energy hip fractures, which have a major impact in terms of mortality, mobility and loss 
of function in activities of daily living in this segment of the population.  
Objectives 
To determine the impact in terms of functional recovery, return to pre-hip fracture 
functional status, of elderly patients treated with the new multimodal therapeutic exercise 
programme and follow-up for one year compared to patients treated with the previously 
developed standardised nursing care plan at the Hospital San Juan de Dios de León.   
Methodology 
Observational study of ambispective cohort  with two groups, an exposed cohort 
(retrospective) and a non-exposed cohort (protective factor), made up of people over 65 
years of age referred from the Emergency Department of the University Care Centre of 
León (CAULE) with a confirmed diagnosis of hip fracture, who underwent hip fracture 
surgery in theHospital San Juan de Dios de León during the years 2020 and 2021. 
 
In order to carry out an analysis of the new care model proposed by the area 
oforthogeriatricsfor the year 2021: functional recovery programme and its follow-up 
through a digital application, the entire simple universe will be included (analysis of the 
complete cohort) with follow-up over a period of one year. 
 
Keywords (maximum 5) 
Hip fractures, Physiotherapy, Functional capacity, Frail elderly, 
 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
BACKGROUND AND CURRENT STATUS OF THE ISSUE 
Introduction. 
Spain is one of the countries with the highest life expectancy at birth in the world, with a 
life expectancy of 80.0 years for men and 85.6 years for women in 2015 (1). This has led 
to a considerable increase in the population of elderly people over the last century (2).  
This increase does not imply that this high life expectancy is accompanied by years of 
good health, as older people may suffer from diseases and health problems that lead to 
a loss of quality of life, without resulting in immediate death (3-5).  
One of the most important problems associated with ageing is hip fractures, as it 
generates a significant impact in terms of morbidity, mortality and functional 
deterioration. In Spain, this problem causes an incidence of 103 cases per 100,000 
inhabitants, with the rate increasing from the age of 75 onwards to 2,534 per 100,000 
inhabitants (6.7).  
Hip fractures have a very important impact on older people, since in addition to their 
functional impact on gait, they have an associated inability to perform other activities of 
daily living and a cognitive impact (8). 
Following hip fractures, these patients require many modifications to their daily lives, 
ranging from increased assistance at home to the need for residential care. This leads 
to increased health care costs, not only during the hospital stay, but also after discharge 
(9). 
Different clinical practice guidelines have been published in recent years with 
recommendations aimed at reaching a consensus and improving the care of patients 
with this pathology (10-13). Despite these recommendations, their implementation in 
Spanish hospitals has been irregular, generating great variability in the care provided in 
this process. This has led to differences in patient care depending on the hospital where 
the patient has been treated, such as: delays in the performance of surgeries, an 
increase in the number of days of hospitalisation, differences in the number of 
rehabilitation sessions and differences in the number of consultations (14,15). 
What does seem clear is that every elderly person who suffers a hip fracture should 
undergo a comprehensive assessment including: the cause of the fall, assessment of 
comorbidity and clinical stability, previous medications, pain, nutritional and hydration 
status, continence, and cognitive, functional and social status (11). 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
According to clinical practice guidelines, rehabilitation should begin from the moment of 
admission, following a multidisciplinary approach, where all those involved are aware of 
the treatment plan and reasonable expectations of recovery (10-13,16).  Early 
mobilisation, weight bearing and active recovery are the basis of rehabilitation treatment, 
resulting in lower mortality six months after the intervention and better ambulation (17). 
It is estimated that 60-80% of elderly people with hip fractures were walking 
independently before the fracture. One of the most important goals is to achieve the 
same degree of ambulation as before the fracture. For this reason, it is important to use 
validated scales that can provide information on the patient's previous state and help to 
assess whether or not the objectives have been achieved. Despite this, only 50% 
manage to recover their pre-fracture state (10).  
To achieve this goal, it is desirable that the patient be operated on as soon as possible 
and begin sitting up the day after surgery, thus facilitating early loading as soon as 
possible, provided that drains or other devices permit (10,11).  
Specific rehabilitation treatment will aim to increase joint mobility; strengthening of the 
gluteal and quadriceps muscles; re-education of walking as soon as possible, first with 
the use of devices and progressively more and more independently (10). 
In recent years, several reviews have studied the implementation of different 
rehabilitation programmes for the elderly after hip fracture, with the aim of increasing 
physical and psychosocial function (18-23).  
Several of these reviews (18,19,21) have focused on comparing multidisciplinary 
rehabilitation with routine orthopaedic care after hip fracture. These studies found that 
multidisciplinary rehabilitation was associated with a modest but significant reduction in 
adverse outcomes such as death. These results were confirmed by Wang et al. (22) who 
found significant differences in terms of reduced mortality during hospitalisation or during 
subsequent follow-up.   
While rapid surgery, early mobilisation and a multidisciplinary team-based approach to 
rehabilitation seem important for restoring the patient's previous function, there are 
discrepancies about the contribution of various components of this intensive approach 
to interventions specifically focused on improving independence such as dressing, 
shopping and interacting in the community (18,21,24).  
Handoll et al. (20) in their review analysed different strategies focused on functional 
recovery of the elderly after hip fracture surgery, both in and out of the hospital setting. 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
Their findings highlight the lack of evidence to determine the most effective strategy to 
help people continue walking after surgery. 
On the other hand, Handoll et al. (19) in another review, analysed the difference in costs 
between patients treated with a multidisciplinary rehabilitation team and regular 
orthopaedic care, being unable to establish which of the two interventions is more 
beneficial from an economic point of view. The study includes some recommendations 
suggesting the inclusion of direct and indirect cost evaluation including both economic 
and social criteria such as the burden on caregivers. These results contrast with those 
found by Sabharwal et al (23), who found that orthogeriatric care models in the treatment 
of frail patients with hip fractures demonstrate a reduction in mortality and morbidity 
rates, with a better cost-effectiveness of treatment.  
Social and psychological factors such as fear of falling, self-efficacy, perceived control 
and coping strategies are considered important in hip fracture recovery. Positive affect" 
(e.g. optimistic outlook) appears to be an important predictor of recovery in activities of 
daily living in various clinical groups and has been associated with a significant reduction 
in the risk of frailty (25). Mastery or internal control has been shown to be associated 
with improved coping, adjustment and general mental health after hip fracture. However, 
strategies such as reorientation, cognitive behavioural therapy and intensive 
occupational therapy did not show changes in psychosocial outcomes, function and 
quality of life. This suggests that the transition between acute care, rehabilitation and 
community care requires further attention. Crotty et al. (18) who did address these social 
and psychological factors in their review, were unable to establish clear criteria for 
recommendation in practice because the design and sample size of the included studies 
were inadequate to draw clear and conclusive conclusions.  
It appears that the concept of multidisciplinary treatment is not without certain limitations 
(26). This type of treatment has been implemented heterogeneously, which makes it 
difficult to interpret the results obtained and, therefore, to determine best practice (22,23).  
Research has addressed the study of different functional parameters with multiple 
results, however, the aspect of patient participation has been less studied despite being 
described as the most important outcome for people with disabilities, their families and 
society (27). Encouraging patients to take an active role has been shown to lead to 
greater motivation and better outcomes. However, the way in which care after hip 
fracture is structured, despite the many benefits that can be found, has been described 
as a possible limiting factor for patient participation because staff are focused on the care 
of the patient and often do not focus on identifying the personal needs of patients (26). 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
Based on all of the above, the comprehensive treatment of patients with a hip fracture 
does not only include the surgical aspect, but is much more complex. It should aim to 
reduce mortality and recover the functional and psychosocial situation prior to the 
fracture, trying to achieve these objectives in the shortest possible time and at the lowest 
possible cost. 
Justification of the Study 
In recent years there has been an increase in the number of hip fractures and this is 
expected to continue until 2050. From 1.26 million in 1990 to 21.3 million in 2050 (28). 
Given the ageing of Western populations, the total number of hip fracture cases and their 
economic consequences are likely to increase considerably. This, coupled with the 
negative outcome for survivors, many of whom end up being more dependent than 
before the fracture, calls for studies that address the effectiveness of a functional 
recovery programme that addresses both the physical and psychosocial spheres of the 
patient, both in and out of hospital.  
The target population of this study is an ageing population, living in a rural environment, 
far from relatives or people who can help them with daily tasks and with difficulties in 
accessing the different resources to achieve an optimal recovery. These people therefore 
need a level of functional recovery that can give them back the level of independence 
they had before the hip fracture. 
 
 
 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
HYPOTHESES AND OBJECTIVES 
 
Overall objective 
• 
To determine the impact in terms of functional recovery, return to pre-hip 
fracture functional status, of elderly patients treated with the new multimodal 
therapeutic exercise programme and follow-up for one year compared to 
patients treated with the previously developed standardised nursing care plan 
at the Hospital San Juan de Dios de León.  
 
Specific objectives 
• 
To describe the improvement in gait ability in patients undergoing hip surgery 
after a functional recovery programme compared to the historical control 
group (exposed cohort). 
• 
To describe the clinical and functional characteristics of the patients operated 
on for hip fracture in the SJD hospital in León who are being followed up by 
the new system of care implemented in comparison with the historical control 
group (exposed cohort). 
• 
To analyse risk and protective factors related to the level of dependency and 
mortality at 30 days and one year of follow-up in patients operated on 
hipfractureat the SJD hospital in León. 
• 
To describethe impact of a functional recovery programme on the prevention 
and treatmentof sarcopeniain the new unexposed cohort.  
• 
To describe the quality of life and patient-reported outcomes in the new 
unexposed cohort. 
• 
To analyse the impact of a functional recovery programme on the prevention 
of falls in elderly patients who have undergone hip fracture surgery.  
 
Hypothesis 
Amultimodalfunctional recoveryprogrammeoftherapeutic exercisewith patient follow-
upafter hip fracture surgery in older people can achieve better resultsthanstandard 
practice (standardised nursing care plan) in terms ofrecovery of functional status prior to 
hip fracture. 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
METHODOLOGY 
Study design 
Longitudinal analytical observational study ofambispectivecohortswith two groups, an 
exposed cohort (retrospective) and a non-exposed cohort (protective factor),made up of 
people over 65 years of age referred from the Emergency Department of the University 
Care Centre of León (CAULE) to theHospital San Juan de Dios de León (HSJD) with a 
confirmed diagnosis of hip fracture and whounderwent hip fracture surgery in the latter 
during the years 2020 and 2021, and who will be followed up during the year after 
surgery, in the latter, to undergo hip fracture surgeryduring the years 2020 and 2021 and 
who will be followed up during the year following the surgery. 
Two groups: 
• 
Non-exposed cohort (protective factor):group of patients operated on during the 
year 2021 in HSJD for hip fracture and to which the new programme 
implementing functional recovery and therapeutic exercise will be applied with 
follow-up for one year. The implementation of a functional recovery plan and 
subsequent follow-up is considered a protective factor in relation to the loss of 
functionality. 
• 
Exposed cohort (retrospective): complete cohort of patients operated on during 
the year 2020 in HSJD for hip fracture and to whom no specific functional 
recovery plan was applied.  
 
Ethical aspects 
The ethical considerations and good clinical practices set out in the Code of Good 
Practice in Research of the Fundación de la Orden Hospitalaria San Juan de Dios, 
following the latest version of the Declaration of Helsinki (2013) and the Taipei 
Declaration (2016) regarding the custody of health databases, will be taken into account. 
1. Clinical Research Ethics Committee and/or Institutional Review Board. 
Documented approval will be obtained from the Fundación San Juan de Dios.  
2. Patient information and consent. Informed consent (IC) will be requested from all 
individuals who voluntarily participate in this study. Participants will be informed of 
the purpose and objectives of the study and the type of participation that will be 
requested of them, by means of a patient information sheet (HIP). The decision to 
withdraw from the project during the course of the project will be respected at all 
times. Consent to participate may be revoked at any time without any detriment to 
the participant.  

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
3. Confidentiality. In accordance with Organic Law 3/2018, of 5 December, on 
Personal Data Protection and guarantee of digital rights (29), only data that are 
strictly necessary for the purposes of the study will be obtained. All information will 
be stored in a computerised archive with access limited to authorised study 
personnel, with a double password for research purposes. No data that could reveal 
the personal identity of the participating subjects will appear in any of the study 
reports. 
The investigators undertake to preserve the confidentiality of the data as provided for 
in the Law on Patient Autonomy, Information and Clinical Documentation (Law 
41/2002 of 14 November 2002) (30), and will inform patients that all data will be kept 
in computerised format and in a strictly confidential manner. All project investigators 
will ensure adherence to applicable personal data protection regulations. Data will 
be destroyed at the end of the study and only data necessary for the present research 
will be used. 
All data will be stored in an anonymised form. The patient will be informed, via the 
HIP, that his or her answers will be anonymised.  
The confidentiality and pseudo-anonymisation of the data obtained will be 
guaranteed by anonymisation through an alphanumeric code. A pseudo-anonymised 
database will be generated and collected on a technological platform that meets the 
highest security standards. Pseudo-anonymisation will be maintained in the 
exploitation of the data. 
Any personally identifiable information will be securely stored by computerised 
methods in the participating centres and by the PI of the project. 
Study subjects 
Target population  
The target population will be made up of people over 65 years of age referred from the 
Emergency Department of the Centro Asistencial Universitario de León (CAULE) with a 
confirmed diagnosis of hip fracture, who are going to undergo hip fracture surgery at the 
HSJD. 
 
Eligibility criteria for the unexposed cohort (protective factor). 
Inclusion criteria: 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
• 
Patients referred from the Emergency Department of the Complejo Asistencial 
de León (CAULE), with confirmation of the medical diagnosis of hip fracture by 
means of anterior-posterior and lateral radiography.  
• 
Be over 65 years of age. 
• 
Ability to walk before the fracture with or without the aid of instruments or people.   
• 
Have signed the informed consent to participate in the research project. 
• 
With access to a smartphone mobile phone with the option of installing 
applications. 
Exclusion criteria:  
• 
Polytrauma patients will be excluded. 
• 
Metastatic origin of the fracture. 
• 
Periprosthetic fracture.  
• 
Patients with cognitive impairment that makes it impossible for them to use 
the PPP and who are not accompanied by a responsible person during the 
recovery process. 
Withdrawal criteria:  
• 
Mortality at hospital discharge. 
• 
Presentation of complications. 
• 
Non-compliance with the therapeutic plan or assessment process. 
 
Eligibility criteriafor the exposed (retrospective) cohort.  
Inclusion criteria: 
• 
Patients referred from the Emergency Department of the Complejo Asistencial 
de León (CAULE), with confirmation of the medical diagnosis of hip fracture by 
means of antero-posterior and lateral radiography. 
• 
Be over 65 years of age. 
• 
Ability to walk before the fracture with or without the aid of instruments or people.   
Exclusion criteria:  
• 
Polytraumapatients will be excluded. 
• 
Metastaticoriginof the fracture 
• 
Periprostheticfracture. 
 
Sampling 
Sample and procedure for inclusion of patients in the unexposed cohort. 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
In order to carry out an analysis of the new care model (functional recovery programme 
and patient follow-up through a digital application), the entire simple universe will be 
included, a complete cohort analysis, with follow-up at 1, 3, 6 and 12 months using a 
digital 
toolFollow-up 
will 
be 
carried 
out 
at 
6 
weeks, 
4 
months 
and12afterdischargeaccording to the protocol of theorthogeriatricsunit. 
The patient will be given instructions on how to download the application to their mobile 
device. The application is available in the open repository of mobile applications for 
public use. Once the app is installed, the patient will be provided with a personal access 
code that does not include recognisable personal data. This code will be used to connect 
to the therapeutic plan and to the questionnaires provided by the patient when registering 
with the Traumatology Service. Only the principal investigator (PI) will have a system of 
correlation between the code and the patient's personal data,be responsible for its 
safekeeping. 
Sample and procedure for inclusion of patients in the exposed cohort. 
Data will be collected from the medical register reported annually from the HSJD to the 
National Hip Fracture Registry as part of the active research project in which the project 
investigators linked to theHSJDare involved. 
Variables 
In the two groups that form part of this study, different variables specified in the database 
adapted from the National Hip Registry and the International Fragility Fracture Network, 
of which the HSJD is a member, will be collected. 
Until now, data collection and patient follow-up was completed after one month and the 
data was transferred annually to the National Hip Fracture Register. In the new model 
proposed byorthogeriatricsunitof the HSJD, patients will be followed up in person at one 
and a half months, four months and one year, and at discharge, one month after 
discharge, three months, six months and one year, by means of a digital application. 
The variables to be collected are described below: 
First group: variables established in the National Hip Fracture Registry, defined 
according to its protocol 
These scales will be administered to both groups: 
• 
Cohort of unexposed patients:to be administered on the dates indicated.  

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
• 
Cohort of exposed patients (retrospective): data will be retrieved from the 
Exceldata collection system that the medical management of the HSJD manages 
for the follow-up of these patients and the report to the national hip fracture 
registry. 
These variables include socio-demographic, clinical and functional characteristics prior 
to surgery (Table I): 
Table I: Sociodemographic, clinical and functional characteristics prior to surgery. 
Variables  
Unit 
of 
measurement 
Type 
Age 
Years 
Independent 
quantitative 
Genre 
H- Male 
M- Female 
Independent 
qualitative 
Caregiver 
1- Yes 
2- No 
3- Live alone 
Independent 
qualitative 
Preoperative mental assessment. Pfeiffer Test 
(SPMSQ-VE) 
Points (0 to 10) 
Qualitative 
Mobility RNFC ladder 
Levels (1 to 11) 
Qualitative 
Pre-fracture 
mobility. 
Gait 
assessment 
scale 
(mFAC). 
Levels (0 to 6) 
Qualitative 
Side affected by the fracture 
D- Law 
I- Left 
Qualitative 
Abbreviations: 
SPMSQ-VE: 
Short 
Portable 
Mental 
Status 
Questionnaire, 
(mFAC): 
ModifiedFunctionalAmbulatoryClassificator,RNFC: Registro Nacional de Fractura de Cadera. 
 
• 
Preoperative 
mental 
assessment. 
PfeifferTestor 
"Short 
Portable 
MentalStatusQuestionnaire" (SPMSQ-VE) (32) 
It assesses the patient's cognitive status at the time of administration. It consists 
of 10 questions that are asked prior to surgery, inwhich errors are computed The 
test should be performed as close to the patient's baseline cognitive state as 
possible. 
The inter- andintra-observerreliabilityof the SPMSQ-VE is 0.738 and 0.925 
respectively, with an internal consistency value of 0.82 (32) 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
Pfeiffertesttranslated and validated in Spanish 
1. What day is today? (Month, day, year). 
2. What day of the week is today? 
3. Where are we now? 
4. What is your telephone number? (If no telephone, street address).  
5. How old are you? 
6. What is your date of birth? 
7. Who is the current Prime Minister?  
8. Who was the previous Prime Minister? 
9. Tell me your mother's first surname. 
10. Starting at 20, subtract 3 by 3 successively until you reach 0. 
Errors are scored, 1 point per error. A score of three or more indicates cognitive 
impairment. If the educational level is low (elementary education), one more error 
is allowed for each category. If the level of education is high (university), one level 
less is allowed. 
This scale is only administered prior to surgery to assess the patient's cognitive 
status. 
This scale is administered on entry. 
• 
Pre-fracture mobility, according to the national fragility hip fracture 
registry(33). 
Gait is the parameter most strongly associated with frailty states, with gait speed 
being the parameter most commonlyassociated with frailty(34,36).This is why it 
is so important to recover functions and capacities in this area of movement. This 
scale is very easy to use and apply and is used by the national fracture registry, 
which allows us to make comparisons and statistical analyses with the results 
published with this registry. 
It assesses by ability levels ranging from 0 to 11. Its design allows firstly to 
determine gait ability and secondly to see the evolution and establish treatment 
guidelines. 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
Capacity levels: 
o Level 1-Independent mobility inside and outside the home without 
technical aids 
o Level 2- Independent mobility inside and outside the home, with technical 
assistance. 
o Level 3- Independent mobility inside and outside the home with two 
technical aids or walker. 
o Level 4- Independent mobility only indoors without technical assistance. 
o Level 5- Independent mobility only indoors with a technical aid. 
o Level 6- Independent mobility only indoors with two technical aids or 
walker. 
o Level 7- Independent mobility only within the house under personal 
supervision.  
o Level 8- Mobility only within the home with little assistance from a person. 
o Level 9- Mobility only within the home with a lot of help from a person. 
o Level 10- Mobility with two people or no mobility. 
o Level 11- Unknown. 
For simplicity this variable is summarised in these questions: 
§ 
Technical aids (yes/no). 
§ 
Outside/inside the home. 
§ 
And note the best situation, i.e. it is better with a cane outside than 
without help at home. 
This scale is administered at admission, 6 weeks, 4 months and 1 year. 
• 
ModifiedFunctionalAmbulatoryClassifier(mFAC)(36). 
It is a scale that assesses different levels of ability by grading them between 0 
and 6. Its design allows firstly to determine gait ability and secondly to see the 
evolution and establish treatment guidelines. The modified gait assessment scale 
has shown anintraclasscorrelation coefficient(ICC)= 0.960, with a 95% 
confidence interval: 0.942-0.972, an inter-observer agreement Cohen's kappa 
index of 0.83 (CI: 0.69-0.97) and a validity ρ= 0.814 (36-38)   
The capacity levels for this scale are: 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
o Level 0: Patient who cannot remain seated for more than 1 minute without 
the help of the backrest and armrest. 
o Level 1: Patient who can remain seated without the aid of the backrest 
and armrest for more than 1 minute. 
o Level 2: non-functional ambulation. Walking with great physical 
assistance from a person,and/or walking is only possible within a therapy 
session at home, or in hospital, between parallel bars 
o Level 3: ambulation in the home, walking with light physical contact with 
a person. Is able to walk only indoors, on flat, horizontal surfaces, usually 
within a defined area. 
o Level 4: walks autonomously in the home or neighbourhood environment, 
but needs supervision by a person. They can walk on uneven surfaces 
and can climb an occasional step. 
o Level 5: independent community walking. Can walk on uneven terrain, up 
and down steps, ramps, kerbs, etc.  Can walk considerable distances, but 
with obvious limp. 
o Level 6: walks normally both indoors and outdoors, in the absence of a 
limp or other abnormality. 
 
This scale is administered at admission, 6 weeks, 4 months and 1 year. 
 
Second group: the variables collected in this second section form part of the new 
model of care established by theorthogeriatricsservice,whereby the hip fracture 
patient will be followed up for up to one year after the intervention, therefore, they 
are variables that can only be measured in the cohort of unexposed patients. 
 
Patient follow-up variables (Table II):  
Table II: Patient follow-up variables 
Variables  
Unit 
of 
measurement 
Type 
Mobility RNFC ladder 
Levels (1 to 11) 
Qualitative 
The walking capacity assessment 
scale (mFAC). 
Levels (0 to 5) 
Qualitative 
Level 
of 
physical 
dependency 
(Barthel Index) 
Points (0 to 25) 
Quantitative 
SARCOPENIA (SARC-F Scale) 
Points (or a10) 
Qualitative 
 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
Table II (continuation): Patient follow-up variables 
 
Variables  
Unit 
of 
measurement 
Type 
Functional 
Capacity 
and 
Pain 
(Oxford Hip Score) 
Points (0 to 48) 
Quantitative 
and 
Qualitative 
Falls Risk (STRATIFY Scale) 
Points (0 to 5) 
Quantitative 
and 
Qualitative 
Medical complications 
0= Fall.  
1= Pneumonia. 
2= New fractures.  
3= Dementia. 
4= Acute 
Myocardial 
Infarction  
5= Pulmonary 
embolism. 
6=Deep vein 
thrombosis; 
7=Death. 
 
Qualitative 
Quality 
of 
life 
analysis: 
questionnaire EQ-5D-5L 
Levels (1 to 3125) 
Points (0 to 100) 
Qualitative 
Quantitative 
Abbreviations: RNFC: National Hip Fracture Registry, mFAC: Modified Functional 
Ambulatory Classificator,  
• 
Level of dependency: the Spanish version of the Barthel Index will be used 
(Annex I). The "Barthel Index" provides quantitative information on the level of 
dependence for activities of daily living by measuring ten activities that are 
considered basic (441,42). This scale has been used in other studies and shows 
a direct relationship between high levels of dependency and poor physical health 
(441). "The Barthel Index has demonstrated good inter-observer reliability, with 
Kappa indices between 0.47 and 1.00, intra-observer reliability with a Kappa 
index between 0.84 and 0.97 and internal consistency with a Cronbach's alpha 
of 0.86-0.92 (39-41).  
Test results: 
o Values: 0-20 total dependency. 
o Values: 21-60 severe dependence. 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
o Values: 61-90 moderate dependence. 
o Values: 91-99 low dependency 
o Values: 100 independence.  
This scale is administered at 6 weeks, 4 months and 1 year.  
• 
Sarcopenia assessment: using the SARC-F scale (ANNEX II) (42). 
It is an easily accessible questionnaire, validated in Spanish, which allows the 
identification of subjects at risk of sarcopenia. The maximum score is 10 points. 
A score of < 4 points after the test indicates an acceptable state of health, while 
any score higher than this indicates a risk of sarcopenia (43). 
This scale is administered at 6 weeks, 4 months and 1 year. 
• 
Assessment of functional capacity and specific hip pain: "Oxford Hip Score 
(OHS)" (ANNEX III) 
It has high repeatability and reliability, with a Cronbach's Alpha value of 0.84 
preoperatively, ICC=0.94, and 0.89 at six months and one year (44). 
It is a 12-item questionnaire, each item is answered on a five-level Likert-type 
scale where 4 is the minimum impact and 0 the most unfavourable (45).  
Results: 
0-19: Severe impact. 
20-29: Moderate to severe impact.  
30-39: Mild to moderate impact.  
40-48: Satisfactory condition. 
This scale is administered at 1, 3, 6 and 12 months.  
• 
Monitoring of adverse events. 
During the follow-up period, information will be collected on variables derived 
from post-surgical and medical complications, and falls risk monitoring will be 
performed. 
o Adverse events. Catalogued in: 
0= Fall.  

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
1= Pneumonia. 
2= New fractures.  
3= Dementia. 
4= Acute Myocardial Infarction. 
5= Pulmonary embolism. 
6=Deep vein thrombosis. 
7= Death. 
This scale is administered at 6 weeks, 4 months and 1 year. 
o Falls risk scale: STRATIFY scale. 
It can predict which patients are at high risk of falls, with sensitivity values 
of 92% and specificity of 68% for the elderly population (46).  
The total score of the STRATIFY scale is obtained based on the sum of 
the answers to the five questions, which can take values between zero 
and five. A score of 0 corresponds to a risk considered low, equal to 1 
corresponds to a moderate risk and, finally, greater than or equal to 2 
corresponds to a high risk (47). 
Question:  
1. Patient hospitalised for falls or with episodes of falls during 
hospitalisation? 
2. Restless patient?  
3. Are you a patient with visual impairment that affects your daily 
activity?  
4. Patient with a frequent need to use the toilet?  
5. Does the patient have a transfer or mobility score of 3 or 4? 
However, in the last question, the score is obtained by combining two 
answers from the modified Barthel index in relation to, respectively, the 
patient's ability to: 
o Transferring from bed to a chair  
0: incapable. 
1: needs significant assistance. 
2: Needs minimal assistance. 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
3: Independent. 
o Level of mobility of the patient: 
0: Immobile. 
1: Independent with the help of a wheelchair. 
2: Use walking aids or walk with the help of a person. 
3: Independent. 
This scale is administered at 6 weeks, 4 months and 1 year. 
• 
Quality of life analysis: EQ-5D-5L questionnaire (ANNEX IV) (48).  
It is a self-administered questionnaire divided into two parts, the descriptive 
system and the Visual Analogue Scale (VAS).  
o The descriptive system EQ-5D-5L. describes health status along five 
dimensions:  
§ 
Mobility. 
§ 
Self-care. 
§ 
Daily activities. 
§ 
Pain/discomfort.  
§ 
Anxiety/depression. 
Each of these dimensions has five possible responses or severity levels: 
no problems (1), mild problems (2), moderate problems (3), severe 
problems (4) and extreme problems/impossibility (5). The participant 
should indicate the level that best reflects his/her status for each of the 
dimensions, describing his/her status using five digits with values ranging 
from 1 to 5, with the best health status being 11111 and the worst 55555. 
The combination of these levels defines a total of 3125 (55) health states. 
o The Visual Analogue Scale (VAS). Assessment by means of a 20 cm 
millimetre scale in a vertical position. At the top of the scale is the 
message "the best state of health you can imagine" with a value of 100, 
at the bottom the message "the worst state of health you can imagine" 
with a value of 0.  
This scale is administered at 1, 3, 6 and 12 months.  
Data collection procedure. 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
The clinical data of the exposed cohort corresponding to the patients operated on during 
the year 2020 will be extracted from the data collection records that the medical 
directorate manages for the follow-up of these patients and the report to the National Hip 
Fracture Registry. 
The clinical and care data of the unexposed cohort of patients who will undergo surgery 
in 2021 will be collected by the trauma team during scheduled patient follow-up visits 
and by the patient or the patient's caregiver using a mobile application. This data will be 
recorded and the PI will be responsible for the safekeeping and processing of the data 
in accordance with current legislation. 
The present study is part of a global project to monitor the cohort of patients with hip 
fractures operated on at the HSJD. This project is a "real world data" study in which all 
the variables of routine practice are collected through a technological application that 
allows the clinical situation of the patient to be known in real time. The information will 
be collected through the Caaring® app, developed by Persei Vivarium, with the specific 
programme for the care of hip fracture patients. 
The patient, or the responsible person in patients with cognitive impairment, will receive 
instructions on how to download the mobile application to their device from an open 
repository of publicly available mobile applications. The patient will be provided with an 
access code in which no recognisable data is included. This code allows connection to 
the questionnaires and information provided by the HSJD trauma service. Only the PI 
will have a system of correlation between the code and the patient's personal data, and 
will be responsible for its safekeeping. 
The app has two different profiles (doctor, patient), with the researchers being able to 
enter the data from the face-to-face assessments and the patient or main caregiver the 
follow-up data from home. 
The specialist who monitors the patient has a control panel on the web-app, where 
he/she has access to risk alerts generated by the system based on the data collected 
and the clinical rules established for this purpose. 
Content of the tool: 
The tool has two types of content: 
• 
Questionnaires for the collection of data on the clinical, functional and quality of 
life evolution of the patient as shown in table III. 
 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
Table III. Summary of variables, assessment instruments and collection period 
Variable 
Questionnaire 
Time of administration 
March Capacity 
RNFC scale 
Entry, at 6 weeks, 4 months and 
1 year. 
The 
walking 
capacity 
assessment scale (mFAC). 
Entry, at 6 weeks, 4 months 
and 1 year. 
Physical capacity 
Barthel Index 
At 6 weeks, 4 months and 1 
year. 
Oxford Hip Score Scale 
At the 1st, 3rd, 6th and 12th 
month. 
Sarcopenia 
SARC-F Scale 
At 6 weeks, 4 months and 1 
year. 
Adverse Events 
STRATIFY scale 
At 6 weeks, 4 months and 1 
year. 
Medical complications (ad hoc 
questionnaires) 
At 6 weeks, 4 months and 1 
year. 
Quality of life 
Questionnaire EQ-5D-5L 
At the 1st, 3rd, 6th and 12th 
month. 
 
 
• 
The functional recovery programme designed and implemented as standard 
practice from 1 January 2021. This programme consists of a series of 
presentations and videos, in simple language with information and 
recommendations. It will provide answers to patients' most frequently asked 
questions and will also allow patients to receive reminders regarding their care 
(recommended exercises, precautions to take in certain circumstances, alerts, 
etc.).  
It is the clinician and the patient, or family member if applicable, who enters the data 
directly into the application, prior to accepting the legal clauses to that effect. 
The study variables collected in the project are included among the clinical variables 
included in the orthogeriatric protocol for the care of hip fracture patients at the HSJD. In 
order to analyse those established for this study, the variables will be extracted from the 
data collection platform, the PI being responsible for the storage and processing of the 
data in accordance with current legislation. 
 
Limitations of the study 
The project poses a number of constraints that need to be taken into consideration: 
• 
The current pandemic situation affecting the hip fracture care process. 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
• 
The necessary involvement of the relative or the residence in the therapeutic 
process. 
• 
Adherence to the application for data collection from the patient's experience. 
• 
The use of a mobile application for data collection and the implementation of the 
recovery programme in an ageing population. A specific follow-up will be 
established by the research team to support participants who present any kind of 
difficulty. 
• 
Thosederived from an observational study, which is not conducted under the 
control and randomisation conditions of a clinical trial 
 
 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
WORK PLAN (ANNEX V) 
 
This research project is intended to be carried out in the Functional Recovery Unit 
integrated in the Orthogeriatrics Service of the HSJD and has the following work plan: 
• 
Administrative Phase.  
Complete development of the project in writing and submission for approval to 
the Doctoral Commission of the University of Murcia and the Research 
Commission of the Order of San Juan de Dios. Once the project has been 
approved, it will be submitted to the Clinical Research Ethics Committee (CEIC) 
as deemed appropriate. 
• 
Initial Phase-Start-up. Duration 18 months. 
The programme will start when the patient is admitted to hospital for hip fracture. 
Participants who meet the eligibility criteria for the study will be recruited and data 
collectedParticipants will be informed of the purpose of the study (Annex VI) and 
their written informed consent will be requested (Annex VII). 
Description of the process: 
• 
Candidate 
selection: 
the 
patient 
will 
be 
cared 
for 
by 
orthogeriatricsunitaccording to its standard clinical practice protocol 
approved by the medical management, and based on the care model 
established by the National Hip Fracture Registry.  
• 
If the patientis admitted from the emergency department, a referral to 
geriatrics will be requested to assess the patient. 
• 
Explanation of the programme and request for informed consent 
(Annexes VI and VII): at the time of admission, an interview will be held 
between the patient or relative and the doctor in charge (traumatology 
service) explaining the process for patients withosteoporotichipfracturein 
the Hospital; which encompasses the set of coordinated medical 
decisions (Emergency, Traumatology, Geriatrics) with the aim of obtaining 
the highest quality care, shorter hospital stay with the maximum level of 
independence and avoiding a second fracture. In the same way and at the 
same time, the multimodal plan of therapeutic exercise and functional 
recovery that will help them during their recovery process will be explained 
to them.  

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
Subsequently, the patient will be informedof the data collection process, 
mobile application and follow-up for 1 year, and signatures will be 
requested for informed consent for anaesthesia, surgery and participation 
in the study.If the patient accepts,Caaring®application. 
Profiles of patients whose clinical circumstances permit, a corroborated 
history should be taken, including: 
o Premorbid function and mobility. 
o Available social support (including whether the patient already 
has a caregiver or whether someone is willing and able to 
provide such support) 
o Relevant current clinical conditions 
o State of mind. 
• 
Hip Surgery.  
• 
Recovery programme (protocol of action that replaces the usual practice 
developed previously): 
o Specific hip fracture recovery programme,restoring the mobility, 
strength and balance of the operated patient, in order to facilitate 
the return to a functional state as close as possible to the state 
prior to surgery and in the shortest possible time, as detailed in 
Annex VIII. This programme is part of the standard treatment 
protocol 
implemented 
since 
January 
2021 
by 
theOrthogeriatricsUnit of the HSJD. 
This programme is divided into 5 phases, each of these phases 
coincides with a level of the gait assessment scale. Each individual 
will start at the level assigned by the doctor and will only have 
access to the videos of the indicated level and the levels below it. 
As the patient meets the recovery goals, the physician will provide 
access to the higher level videos.The functional recovery plan 
begins the day after the hip fracture and continues after the patient 
has been discharged for a total of 16 weeks. 
o The therapeutic plan for the historical control group (standard 
practice until 31 December 2020) consisting of postural changes 
described in the standardised nursing care plan. Within this plan, 
the patient was moved to a sitting position prematurely (within the 
first 24 hours) and started to ambulate within the following 48 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
hours, provided that the patient's general condition allowed it. This 
group did not receive any specific functional recovery plan. 
• 
The patient is discharged from hospital and will be assigned a link where 
he/she will be able to access the online platform to send information from 
the questionnaires sent during the established periods of 1, 3, 6 and 12 
months and will also be sent videos illustrating the rehabilitation exercises 
that he/she will have to perform during this period. The patient and/or 
carer will be explained how the tool works, how to access the digital 
information content and how to access the questionnaires. A means of 
contact will be provided to resolve doubts, if any. The PI will have access 
through the web/app platformto a control panel where he/she will be able 
to detect a patient's lack of adherence, if any, or alerts related to clinical 
evolution, allowing for exhaustive monitoring of the patient. 
 
• 
Analysis of results: The data collected will be analysed with the SPSS 
programme. The mean, median and standard deviation of each of the variables 
will be calculated. Based on the data obtained from the existing literature(31), 
having selected a sample of 67 patients, a normal distribution can be assumed 
for all variables 
For baseline demographic and clinical characteristics, a comparison of means for 
quantitative variables (t-Student), and of proportions (Chi-square) for 
qualitativewill be performed 
The statistical analysis will be carried out with a confidence level of 95%, so that 
statistically significant values will be considered to be those whose probability is 
< 0.05.  
• 
Dissemination of results: the results of this study will be presented for 
dissemination in scientific journals and specialised conferences. 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
 
 
 
BUDGET  
 
 
CONCEPT 
 
COST (€) 
 
AVAILABLE 
Human 
resources 
Translation service 
 
NO 
Material 
resources 
Office supplies 
 
NO 
Hard disk (2 units) 
200 
NO 
Laptop (2 units) 
 
YES 
Subtotal 1 
 
 
2600 
Dissemination 
costs 
Publication of open access articles 
 
NO 
Attendance at national congress (2 congresses: 
registration, travel and subsistence. 
 
NO 
Attendance at international congress (2 congresses: 
registration, travel and per diem) 
 
NO 
Subtotal 2 
 
 
3500 
Other 
Travel to centres 
 
NO 
Acquisition of bibliography 
 
NO 
SPSS License 
 
NO 
Professional Office Package  
100 
NO 
Subtotal 3 
 
2400 
TOTAL 
 
8500 (€) 
 
 
 
 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
INSTITUTIONAL LINKAGE 
 
The project will be carried out at the HSJD and will be carried out by staff from the centre 
itself, staff from the Centro Universitario San Rafael Nebrija and the Research 
Department of the Fundación San Juan de Dios.  
 
All three centres belong to the Order of St. John of God. 
 
 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
DISSEMINATION PLAN 
 
This project is relevant because of its impact at the clinical and care level and adds value 
through the implementation of the functional recovery programme using a technological 
medium. 
It is intended to present the results of this study in high impact scientific publications 
related to geriatrics, orthopaedics and physiotherapy.  
The presence at national congresses of traumatology, geriatrics and physiotherapy of 
the respective scientific societies is an objective within the dissemination plan. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
 
 
REFERENCES 
 
Health indicators 2017 Evolution of health status indicators in Spain and their 
magnitude in the context of the European Union, Madrid Ministerio de Sanidad, Servicios 
Sociales e Igualdad, 2018.pdf.  
 
Izquierdo M, Cadore L, Casas. Physical Exercise in the Frail Elderly: An Effective 
Way to Prevent Dependence, Kronos. 2014; 13(1). pdf.  
3. 
Caruso C. Biomarkes of aging. Front Biosci [Internet]. 2010 [cited 2020 Mar 11]; 
S2(2): 392-402. Available from: https://www.bioscience.org/2010/v2s/af/72/list.htm 
4. 
Steves CJ, Spector TD, Jackson SHD. Ageing, genes, environment and 
epigenetics: what twin studies tell us now, and in the future. Ageing [Internet]. September 
2012 
[cited 
2020 
Mar 
11];41(5):581-6. 
Available 
from: 
https://academic.oup.com/ageing/article-lookup/doi/10.1093/ageing/afs097 
5. 
Kirkwood TBL. A systematic look at an old problem. Nature [Internet]. February 
2008 
[cited 
2020 
March 
11];451(7179):644-7. 
Available 
from: 
http://www.nature.com/articles/451644a 
6. 
Institute of Health Information. Annotated statistics: hip fracture care in NHS 
hospitals. Madrid: Ministry of Health and Social Policy 2010.  
7. 
Herrera A, Martínez AA, Ferrandez L, Gil E, Moreno A. Epidemiology of 
osteoporotic hip fractures in Spain. Epidemiology of osteoporotic hip fractures in Spain. 
Int Orthop [Internet]. February 2006 [cited 2020 Apr 8];30(1):11-4. Disponible en: 
http://link.springer.com/10.1007/s00264-005-0026-2 
8. 
de Miguel Artal M, Roca Chacón O. Intervention of a geriatric UFISS in patients 
with hip fracture admitted to a Traumatology Service. Rev Esp Geriatría Gerontol 
[Internet]. 
March 
2014 
[cited 
9 
April 
2020];49(2):96-7. 
Available 
from: 
https://linkinghub.elsevier.com/retrieve/pii/S0211139X13001224 
9. 
The REFReSH study group, Leal J, Gray AM, Prieto-Alhambra D, Arden NK, 
Cooper C, et al. Impact of hip fracture on hospital care costs: a population-based study. 
Osteoporos Int [Internet]. February 2016 [cited 2020 Apr 9];27(2):549-58. Disponible en: 
http://link.springer.com/10.1007/s00198-015-3277-9 
 
Avellana Zaragoza JA, Ferrández Portal L, Areosa Sastre A, Sociedad Española 
de Geriatría y Gerontología, Sociedad Española de Cirugía Ortopédica y Traumatología. 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
Elderly affected by hip fracture: a guide to good clinical practice in geriatrics. Madrid? 
Elsevier : Spanish Society of Geriatrics and Gerontology; 2007.  
11. 
Bardales Mas Y, González Montalvo JI, Abizanda Soler P, Alarcón Alarcón MT. 
Clinical guidelines on hip fracture. Comparison of their main recommendations. Rev Esp 
Geriatría Gerontol [Internet]. September 2012 [cited 2020 Apr 9];47(5):220-7. Available 
from: https://linkinghub.elsevier.com/retrieve/pii/S0211139X12000728 
12. 
Australian and New Zealand Guideline for Hip Fracture National Hip Fracture 
Database. National Report 2013.  
13. 
The care of patients with fragility fracture. The Blue Book. Published by the British 
Orthopaedic Association (BOABGS). London, 2007.  
 
Muñoz-Pascual A, Sáez-López P, Jiménez-Mola S, Sánchez-Hernández N, 
Alonso-García N, Andrés-Sainz AI, et al. Orthogeriatrics: first multicentre regional 
registry of hip fractures in Castilla y León (Spain). Rev Esp Geriatría Gerontol [Internet]. 
September 
2017 
[cited 
2020 
Apr 
9];52(5):242-8. 
Available 
from: 
https://linkinghub.elsevier.com/retrieve/pii/S0211139X17300598 
 
Sáez López P, Martín Perez E, González Ramírez A, Pablos Hernández C, 
Jiménez Mola S, Vuelta Calzada E, et al. Orthogeriatric activity in public hospitals in 
Castilla y León: description and review of the literature. Rev Esp Geriatría Gerontol 
[Internet]. 
May 
2014 
[cited 
2020 
Apr 
9];49(3):137-44. 
Available 
from: 
https://linkinghub.elsevier.com/retrieve/pii/S0211139X14000183 
16. 
Siu AL, Penrod JD, Boockvar KS, Koval K, Strauss E, Morrison RS. Early 
Ambulation After Hip Fracture: Effects on Function and Mortality. Arch Intern Med 
[Internet]. 
April 
10, 
2006 
[cited 
2020 
Apr 
9];166(7):766. 
Available 
from: 
http://archinte.jamanetwork.com/article.aspx?doi=10.1001/archinte.166.7.766 
 
Penrod JD, Litke A, Hawkes WG, Magaziner J, Koval KJ, Doucette JT, et al. 
Heterogeneity in Hip Fracture Patients: Age, Functional Status, and Comorbidity: 
HETEROGENEITY in HIP FRACTURE PATIENTS. J Am Geriatr Soc [Internet]. 2007 
Mar [cited 2020 Apr 9];55(3):407-13. Disponible en: http://doi.wiley.com/10.1111/j.1532-
5415.2007.01078.x 
 
Crotty M, Unroe K, Cameron ID, Miller M, Ramirez G, Couzner L. Rehabilitation 
interventions for improving physical and psychosocial functioning after hip fracture in 
older people. Cochrane Bone, Joint and Muscle Trauma Group, editor. Cochrane 
Database Syst Rev [Internet]. 20 January 2010 [cited 2020 Apr 13]; Available from: 
http://doi.wiley.com/10.1002/14651858.CD007624.pub3. 
19. 
Handoll HH, Cameron ID, Mak JC, Finnegan TP. Multidisciplinary rehabilitation 
for older people with hip fractures. Cochrane Bone, Joint and Muscle Trauma Group, 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
editor. Cochrane Database Syst Rev [Internet]. October 7, 2009 [cited 2020 Apr 13]; 
Available from: http://doi.wiley.com/10.1002/14651858.CD007125.pub2. 
20. 
Handoll HH, Sherrington C, Mak JC. Interventions for improving mobility after hip 
fracture surgery in adults. Cochrane Bone, Joint and Muscle Trauma Group, editor. 
Cochrane Database Syst Rev [Internet]. March 16, 2011 [cited 2020 Apr 13]; Available 
from: http://doi.wiley.com/10.1002/14651858.CD001704.pub4. 
21. 
Halbert J, Crotty M, Whitehead C, Cameron I, Kurrle S, Graham S, et al. Multi-
disciplinary rehabilitation after hip fracture is associated with improved outcome: A 
systematic review. J Rehabil Med [Internet]. 2007 [cited 2020 Apr 13];39(7):507-12. 
Available from: https://medicaljournals.se/jrm/content/abstract/10.2340/16501977-0102 
 
Wang H, Li C, Zhang Y, Jia Y, Zhu Y, Sun R, et al. The influence of inpatient 
comprehensive geriatric care on elderly patients with hip fractures: a meta-analysis of 
randomized controlled trials. :16.  
 
Sabharwal S, Wilson H. Orthogeriatrics in the management of frail older patients 
with a fragility fracture. Osteoporos Int [Internet]. October 2015 [cited 2020 Apr 
13];26(10):2387-99. Disponible en: http://link.springer.com/10.1007/s00198-015-3166-2 
24. 
Handoll HH, Cameron ID, Mak JC, Finnegan TP. Multidisciplinary rehabilitation 
for older people with hip fractures. Cochrane Bone, Joint and Muscle Trauma Group, 
editor. Cochrane Database Syst Rev [Internet]. October 7, 2009 [cited 2020 Apr 13]; 
Available from: http://doi.wiley.com/10.1002/14651858.CD007125.pub2. 
25. 
Ostir GV, Ottenbacher KJ, Markides KS. Onset of Frailty in Older Adults and the 
Protective Role of Positive Affect. Psychol Aging [Internet]. 2004 [cited 2020 Apr 
13];19(3):402-8. 
Disponible 
en: 
http://doi.apa.org/getdoi.cfm?doi=10.1037/0882-
7974.19.3.402 
26. 
Asplin G, Carlsson G, Zidén L, Kjellby-Wendt G. Early coordinated rehabilitation 
in acute phase after hip fracture - a model for increased patient participation. BMC 
Geriatr [Internet]. December 2017 [cited 12 April 2020];17(1):240. Available from: 
http://bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-017-0640-z 
27. 
Cardol M, Jong BAD, Ward CD. On autonomy and participation in rehabilitation: 
a response. Disabil Rehabil [Internet]. January 2002 [cited 3 May 2020];24(18):1001-4. 
Disponible en: http://www.tandfonline.com/doi/full/10.1080/09638280210152094 
28. 
Marks R. Hip fracture epidemiological trends, outcomes, and risk factors, 
1970&ndash;2009. Int J Gen Med [Internet]. December 2009 [cited 2020 Apr 13];1. 
Available 
from: 
http://www.dovepress.com/hip-fracture-epidemiological-trends-
outcomes-and-risk-factors-1970ndas-peer-reviewed-article-IJGM 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
29. 
Organic Law 3/2018, of 5 December, on Data Protection and the Guarantee of 
Digital Rights. BOE no. 294, of 6 December 2018 pages 119788 to 119857. [Cited: 29 
October 2019]. D at: https://www. boe. es/eli/es/lo/2018/12/05/3.  
30.  
Law 41/2002, of 14 November, basic law regulating patient autonomy and rights 
and obligations regarding clinical information and documentation. BOE no. 274 of 
15/11/2002. C 29 October 2019]. D at: https://www. boe. es/buscar/act. php?id=BOE-A-
2002-22188&tn=1&p=20181206.  
31.  
Tsang RC, Chau RM, Cheuk TH, Cheung BS, Fung DM, Ho EY, Ip EM, Ko BP, 
Lee JY, Liu AK, Ng VP, Tang RS, To KW, Tsang CP. The measurement properties of 
modified Rivermead mobility index and modified functional ambulation classification as 
outcome measures for Chinese stroke patients. Physiother Theory Pract. 2014 
Jul;30(5):353-9. doi: 10.3109/09593985.2013.876563. Epub 2014 Jan 8. PMID: 
24400683. 
32.  
Martínez J M, Dueñas R, Onís M C, Aguado C, Albert C, Luque R. Adaptation 
and validation in Spanish of the Pfeiffer questionnaire (SPMSQ) to detect the existence 
of cognitive impairment in people over 65 years of age. Med Clin (Barc) 2001 Jun 
30;117(4):129-34.  
33.  
Sáez-López P, Ojeda-Thies C, Alarcón T, Muñoz Pascual A, Mora-Fernández J, 
González de Villaumbrosia C, Molina Hernández MJ, Montero-Fernández N, Cancio 
Trujillo JM, Díez Pérez A, Prieto Alhambra D, Caeiro Rey JR, Etxebarria Foronda I, 
Gómez Campelo P, Pareja Sierra T, Tarazona-Santabalbina FJ, López-Giménez R, 
Otero Puime A, Navarro-Caste- llanos L, Queipo Matas R, Jiménez Mola S, López-Peña 
T, Cassinello Ogea C, González-Montalvo JI. National Hip Fracture Registry (RNFC): 
first year results and comparison with other Spanish registries and multicentre studies. 
Rev Esp Public Health. 2019;93: October 18 e201910072. 
34.  
Fallah N, Mitnitski A, Searle SD, Gahbauer EA, Gill TM, Rockwood K. Transitions 
in Frailty Status in Older Adults in Relation to Mobility: A Multistate Modeling Approach 
Employing a Deficit Count: A MULTISTATE TRANSITION MODEL OF FRAILTY 
CHANGES. J Am Geriatr Soc [Internet]. 2011 Mar [cited 2020 Feb 27];59(3):524-9. 
Disponible en: http://doi.wiley.com/10.1111/j.1532-5415.2011.03300.x 
35.  
Iriarte E, Araya A-X. Frailty criteria in older people living in the community: an 
update of the literature. Rev Médica Chile [Internet]. 2016 Nov [cited 2020 Feb 
14];144(11):1440-7. 
Available 
from: 
http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-
98872016001100010&lng=en&nrm=iso&tlng=en 
36.  
Viosca E, Martínez JL, Almagro PL, Gracia A, González C. Proposal and 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
Validation of a New Functional Ambulation Classification Scale for Clinical Use. Arch 
Phys Med Rehabil [Internet]. June 2005 [cited 2020 Mar 25];86(6):1234-8. Available 
from: https://linkinghub.elsevier.com/retrieve/pii/S0003999305000651 
37.  
Chau RM, Chan SP, Wong YW, et al.: cAH Reliability and validity of the Modified 
Functional Ambulation Classification in patients with hip fracture. Hong Kong 
Physiotherapy. june 2013; J, 31: 41-44.  
38.  
García S, Cortés A, Viosca E, Escuder A, González C, Querol M. Validation of 
the functional classification of standing at the Hospital de Sagunto. Rehabilitación 
(Madr).2010;44(1):53-59  
39.  
Cid-Ruzafa J, Damián-Moreno J. Assessment of physical disability: the Barthel 
index. Rev Esp Salud Pública [Internet]. March 1997 [cited 10 October 2019];71(2):127-
37. 
Available 
from: 
http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1135-
57271997000200004&lng=es&nrm=iso&tlng=es 
40.  
Cuesta-Vargas AI, Pérez-Cruzado D. Relationship between Barthel index with 
physical tests in adults with intellectual disabilities. SpringerPlus [Internet]. December 
2014 
[cited 
October 
5, 
2019];3(1):543. 
Available 
from: 
https://springerplus.springeropen.com/articles/10.1186/2193-1801-3-543 
41.  
Duffy L, Gajree S, Langhorne P, Stott DJ, Quinn TJ. Reliability (inter-rater 
agreement) of the Barthel Index for assessment of stroke survivors: systematic review 
and 
meta-analysis. 
Stroke. 
2013 
Feb;44(2):462-8. 
doi: 
10.1161/STROKEAHA.112.678615. Epub 2013 Jan 8. PMID: 23299497. 
42.  
Parra-Rodriguez L, Szlejf C, Garcia-Gonzalez AI, Malmstrom TK, Cruz-Arenas 
E, Rosas-Carrasco O. Cross-Cultural Adaptation and Validation of the Spanish-
Language Version of the SARC-F to Assess Sarcopenia in Mexican Community-
Dwelling Older Adults. J Am Med Dir Assoc. Dec 1, 2016;17(12):1142-6.  
43.  
Cuesta Triana F. Assessment of sarcopenia: from research to clinical practice. 
NutriciÃ3n Hospitalaria. 2019;36:999-1000.  
44.  
Haywood KL, Brett J, Tutton E, Staniszewska S. Patient-reported outcome 
measures in older people with hip fracture: a systematic review of quality and 
acceptability. Quality of Life Research. Apr 1, 2017;26(4):799-812.  
45.  
Paulsen A. Patient reported outcomes in hip arthroplasty registries. Dan Med J. 
May 2014;61(5):B4845.  
46.  
Oliver D, Britton M, Seed P, Martin FC, Hopper AH. Development and evaluation 
of evidence based risk assessment tool (STRATIFY) to predict which elderly inpatients 
will fall: case-control and cohort studies. BMJ. October 25, 1997;315(7115):1049-53. 

 RESEARCH PROJECT APPLICATION REPORT 
 
 
 
47.  
M. Enriquez, M. Aranda-Gallardo, J. Canca-Sanchez, M. Vazquez-Blanco, A. 
Moya-Suarez, J.M. Morales-Asencio. Cross-cultural adaptation of the "STRATIFY" 
instrument for the assessment of falls risk Enferm Clin., 27 (2017), pp. 63-140. 
48.  
van de Ree CLP, Landers MJF, Kruithof N, de Munter L, Slaets JPJ, Gosens T, 
et al. Effect of frailty on quality of life in elderly patients after hip fracture: a longitudinal 
study. BMJ Open. July 2019;9(7):e025941. 
 
 

 
 
 
ANNEXES  
Annex I: Barthel Index Questionnaire (Spanish version) for the assessment of level of 
dependency.  
 
 
 
 
 

 
 
 
 
 
 
 
 
 
Annex II: SARC-F Questionnaire (Spanish version) for the assessment of sarcopenia.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
Annex III. Oxford Hip Score for functional capacity and hip pain. 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
Annex IV. Questionnaire EQ-5D-5L for quality of life 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
Annex IV. EQ-5D-5L Quality of Life Questionnaire (continued) 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
Annex V: Work Plan 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
Annex VI: Participant Information Sheet  
PATIENT/PARTICIPANT INFORMATION SHEET 
 
PROTOCOL NO: 
TITLE OF THE STUDY: Effects of a Multimodal Program of Therapeutic Exercise and Functional 
Recovery With Follow-up in the Elderly After Hip Fracture Surgery Using a Digital Application. 
Observational Study. 
RESEARCH GROUP: 
PRINCIPAL INVESTIGATOR: 
Surname, first name: Zambrano Martín, Joaquín 
Professional category: Physiotherapist 
Email: jzambrano@nebrija.es 
CENTRE: Centro Universitario San Rafael Nebrija 
DATE OF SUBMISSION TO THE RESEARCH COMMISSION: 5 January 2021 
 
INTRODUCTION  
We are writing to you to provide you with correct and sufficient information on the development 
of the study in which you are proposed to participate, so that you can evaluate and judge whether 
or not you wish to take part in it. The study has been approved by the Ethics Committee of the 
Research Commission of the Fundación San Juan de Dios and the Clinical Research Ethics 
Committee (CEIC) of the Hospital de la Princesa de Madrid, in accordance with current legislation.  
Our intention is only that you receive sufficient and correct information so that you can evaluate 
and judge whether or not you want to participate in this study. To this end, please read this 
information sheet carefully and we will answer any questions you may have after the explanation. 
In addition, you are welcome to consult with any other person you consider appropriate.  
VOLUNTARY PARTICIPATION  
You should know that your participation in this study is voluntary and that you can decide not to 
participate or change your decision and withdraw your consent at any time (communicating the 
decision in writing to the principal investigator, according to RD 1090/2015 of 4 December), 
without altering the relationship with the healthcare staff or causing any harm to your treatment.  
GENERAL DESCRIPTION OF THE STUDY* :  
The aim is to explore the care process in elderly patients hospitalised for hip fracture, identifying 
aspects for improvement at each point, with the aim of obtaining the highest quality of care, the 
shortest hospital stay with the highest level of independence and avoiding a second fracture. 
 
 

 
 
 
This programme will be carried out during their hospital stay and for one year after they have 
been discharged from hospital.  
The recovery plan has been reviewed and approved in advance by the relevant ethics committees 
in order to ensure that it is not harmful. 
For the statistical study, a group of people will be selected according to established inclusion and 
exclusion criteria, who will undergo the treatment and recovery recommendations established in 
the hospital protocols. 
The programme consists of specific hip fracture recoveryplanre-establishing the mobility, strength 
and balance of the operated patient, and whose objective is to facilitate the return to a functional 
state as close as possible to the state prior to surgery.  
This programme is divided into five phases coinciding with the different levels of the gait 
assessment scale and will be prescribed by your doctor depending on your physical condition 
after surgery. Each level of exercise is designed to achieve certain goals within your recovery and 
the complete programme will last for a total of 16 weeks. The estimated daily exercise time is 40 
minutes, spread over different times of the day for the lower levels (levels 1, 2 and 3) and 
continuously for levels 4 and 5.  
The exercises have been designed so that you can do them comfortably at home without the 
need to purchase any extra materialand they are explained in a simple way in videos that you can 
watch on your mobile phone. They are simple exercises adapted to your state of health that will 
not require any extra effort and will help you to recover. 
A member of the research team,during your hospital visits or viathe mobile app, will give you 
precise instructions on how to perform the exercises at home (frequency and number of 
repetitions). In addition, you will also be told what data you have to record related to the 
performance of the exercises.  
His progress will be monitored by the research team through the different control visits he has to 
make tothe Traumatology Unit of the Hospital de San Juan de Dios de León (at 6 weeks, 4 months 
and a year) and through the application installed on his mobile phone (1st, 3rd, 6th and 12 
months). In each case, a series of tests and questionnaires will be carried out, through which 
different parameters related to their health will be evaluated and data on quality of life and 
functionality inactivities of daily living will be recorded.  
Apart from having the location (telephone andemail) of the principal investigator indicated 
above,you will have the possibility of making any queries related to the exercise protocol and the 
studythe mobile application and periodic video control calls 
It will be of great importance that they maintain all their usual treatments, informing the principal 

 
 
 
investigator of any new developments (drugs, physiotherapy, etc.) that they incorporate while they 
are part of the study, as well as if any adverse effects appear.  
Sample selection process 
The sample will be obtained from patients admitted to the Hospital Functional Recovery Unit 
integrated in the Geriatrics Service of the Hospital San Juan de Dios de León and who meet the 
established inclusion and exclusion criteria. 
 
BENEFITS AND RISKS OF PARTICIPATING IN THE STUDY  
It is considered that the performance of this treatment will improve his functionality after surgery 
and return him to a situation as similar as possible to the one he had prior to the hip fracture. It is 
also considered the possibility that the results of the study will allow the establishment of a 
scientific basis for the use of a functional recovery programme that will enable a better recovery 
and avoid or reduce the possibility of a second fracture.  
Even if you follow the prescribed protocol, you may not gain any health benefit from participating 
in this study.  
None of the previous studies in which exercises similar to yours have been performed have 
described any adverse effects derived from them. Nor is there any added risk from the diagnostic 
tests to be performed. 
 
ALTERNATIVE TREATMENTS  
Your participation in this study will not change your current treatment regimens or prevent you 
from taking a new drug or other treatment that is considered beneficial to the progression of your 
disease.  
The principal investigator of this study will provide more information on request. 
CONFIDENTIALITY  
The processing, communication and transfer of personal data of all participating subjects will 
comply with the provisions of the Organic Law 03/2018, of 05 December, on the Protection of 
Personal Data and Regulation (EU) 2016/679 of the European Parliament and of the Council of 
27 April 2016 on Data Protection (RGPD). In accordance with the provisions of the 
aforementioned legislation, you can exercise your rights of access, modification, opposition and 
cancellation of data, for which you should contact the head of the study Mr. Joaquín Zambrano 
Martín via email jzambrano@nebrija.es or telephone 615378439.  

 
 
 
The data collected for the study will be identified by a code and only the person responsible for 
the study and members of the participating research team will be able to relate this data to you 
and your medical history. Therefore, your identity will not be disclosed to any person except in 
case of medical emergency or legal requirement, but always maintaining the confidentiality of 
these in accordance with current legislation.  
Only the data collected for the study will be transferred to third parties and to other countries, with 
prior notification to the Spanish Data Protection Agency, and under no circumstances will it 
contain information that can directly identify you, such as name and surname, initials, address, 
social security number, etc. In the event of this transfer, it will be for the same purposes of the 
study described and guaranteeing confidentiality with at least the level of protection of the 
legislation in force in our country.  
Access to your personal information will be restricted to the study leader and members of the 
participating research team, health authorities, the Clinical Research Ethics Committee and 
personnel authorised by the sponsor, when required to check the data and procedures of the 
study, but always maintaining the confidentiality of these in accordance with current legislation.  
FINANCIAL COMPENSATION  
Your participation in the study will not entail any costs for you, nor will it be derived in any way 
from  
OTHER RELEVANT INFORMATION  
Any new information concerning the technique used in the study that may affect your willingness 
to participate in the study that is discovered during your participation will be communicated to you 
by your physician as soon as possible.  
If you decide to withdraw consent to participate in this study, no new data will be added to the 
database, and you may request the destruction of all identifiable samples previously retained to 
prevent further analysis.  
You should also be aware that you may be excluded from the study if the study sponsor or 
investigators deem it appropriate, either for safety reasons, because of any adverse events that 
occur, or because they feel that you are not complying with the established procedures. In either 
case, you will receive an adequate explanation of the reason for your withdrawal from the study. 
By signing the attached consent form, you agree to comply with the study procedures outlined to 
you.  
At the end of your participation you will receive the best available treatment that your doctor 

 
 
 
considers most appropriate for your disease, but you may not be able to continue the study 
treatment. Therefore, neither the investigator nor the sponsor makes any commitment to continue 
such treatment outside of this study. 
 
Date 
 
 
 
Signature of the patient/participant.          
 
 
Signature of the investigator. 

 
 
 
 
 
 Pursuant to Organic Law 03/2018, of 05 December, on the Protection of Personal Data and Regulation (EU) 
2016/679 of the European Parliament and of the Council of 27 April 2016 onDataProtection(RGPD), you are hereby 
informed that your personal data will be stored in the files owned by Fundación San Juan de Dios in order to provide 
you with the services you require, as well as to keep you informed about these and other services that may be of 
interest to you. You may exercise your rights of access, rectification, cancellation and opposition by writing to the 
Director, C/ Herreros de Tejada, 3 - 28016 Madrid. If you do not wish to receive information, please tick the 
following box☐ 
Annex VII: Informed consent. 
INFORMED CONSENT 
PROTOCOL NO: 
TITLE OF THE STUDY: Effects of a Multimodal Program of Therapeutic Exercise and Functional 
Recovery With Follow-up in the Elderly After Hip Fracture Surgery Using a Digital Application. 
Observational Study.  
RESEARCH GROUP: 
PRINCIPAL INVESTIGATOR: 
Surname, first name: Zambrano Martín, Joaquín 
Professional category: Physiotherapist 
Email: jzambrano@nebrija.es 
CENTRE: Centro Universitario San Rafael Nebrija 
DEADLINE FOR SUBMISSION TO THE RESEARCH COMMISSION: 5 January 2021 
 
Yo,__________________________________________________________________ 
                                               (name and surname of the study participant) 
 
• 
I have read the information sheet provided to me.  
• 
I was able to ask as many questions about the study as I could think of.  
• 
I have received satisfactory answers to my questions. 
• 
I have received sufficient information about the study. 
• 
I have spoken to: _________________________________________________ 
                                                                                   (name of researcher)  
 
• 
I understand that my participation is voluntary.  
• 
I understand that I can withdraw from the study:  
Ø Whenever you want.  
Ø Without having to explain.  
Ø Without affecting my health care. 
 
I freely agree to participate in the study.  
Date  

 
 
 
 
 
 Pursuant to Organic Law 03/2018, of 05 December, on the Protection of Personal Data and Regulation (EU) 
2016/679 of the European Parliament and of the Council of 27 April 2016 onDataProtection(RGPD), you are hereby 
informed that your personal data will be stored in the files owned by Fundación San Juan de Dios in order to provide 
you with the services you require, as well as to keep you informed about these and other services that may be of 
interest to you. You may exercise your rights of access, rectification, cancellation and opposition by writing to the 
Director, C/ Herreros de Tejada, 3 - 28016 Madrid. If you do not wish to receive information, please tick the 
following box☐ 
 
 
Signature of participantSignature  
of researcher 

 
 
 
 
 
Pursuant to Organic Law 03/2018, of 05 December, on the Protection of Personal Data and Regulation (EU) 2016/679 of the 
European Parliament and of the Council of 27 April 2016 onDataProtection(RGPD), you are informed that your personal 
data will be stored in the files owned by Fundación San Juan de Dios in order to provide you with the services you require, as well 
as to keep you informed about these and other services that may be of interest to you. You may exercise your rights of access, 
rectification, cancellation and opposition by writing to the Director, C/ Herreros de Tejada, 3 - 28016 Madrid. If you do not wish to 
receive information, please tick the following box 
 
CONSENT OF THE LEGAL REPRESENTATIVE  
 
PROTOCOL NO: 
TITLE OF THE STUDY: Effects of a Multimodal Program of Therapeutic Exercise and Functional 
Recovery With Follow-up in the Elderly After Hip Fracture Surgery Using a Digital Application. 
Observational Study.   
RESEARCH GROUP: 
PRINCIPAL INVESTIGATOR: 
Surname, first name: Zambrano Martín, Joaquín 
Professional category: Physiotherapist 
Email: jzambrano@nebrija.es 
CENTRE: Centro Universitario San Rafael Nebrija 
DEADLINE FOR SUBMISSION TO THE RESEARCH COMMISSION: 5 January 2021 
 
Yo,__________________________________________________________________ 
                                                                 (name and surname of the REPRESENTATIVE) 
en calidad de__________________________________________________________ 
                                                                                            (relationship with the participant) 
De___________________________________________________________________ 
                                                                                           (participant's name) 
 
• 
I have read the information sheet provided to me.  
• 
I was able to ask as many questions about the study as I could think of. 
• 
I have received satisfactory answers to my questions. 
• 
I have received sufficient information about the study. 
• 
I have spoken to: _________________________________________________ 
                                                                                   (name of researcher)  
• 
I understand that YOUR participation is voluntary.  
• 
I understand that I can withdraw you from the study:  
Ø Whenever you want.  
Ø Without having to explain.  
Ø Without affecting my health care. 
 
In my presence it was given to _____________________________________________ 
                                                                                 (name and age of participant) 
all relevant information, adapted to their level of understanding. 

 
 
 
 
 
Pursuant to Organic Law 03/2018, of 05 December, on the Protection of Personal Data and Regulation (EU) 2016/679 of the 
European Parliament and of the Council of 27 April 2016 onDataProtection(RGPD), you are informed that your personal 
data will be stored in the files owned by Fundación San Juan de Dios in order to provide you with the services you require, as well 
as to keep you informed about these and other services that may be of interest to you. You may exercise your rights of access, 
rectification, cancellation and opposition by writing to the Director, C/ Herreros de Tejada, 3 - 28016 Madrid. If you do not wish to 
receive information, please tick the following box 
 
 
And I freely consent to that__________________________________ 
                                                                                              (participant's name) 
participate in this study, and I consent to the access and use of the data under the conditions 
detailed in the participant information sheet provided. 
 
Date     
 
 
 
Signature of the representativeSignature of the  
investigated

 
 
 
 
 
 
Annex VIII: Functional recovery programme.