Clinical trial NCT04919083: Exercise Program and Follow-up in the Elderly After Hip Fracture Surgery Using a Digital Application.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hip Fractures
Keywords: Hip fractures
Physiotherapy
Functional capacity
Frail elderly
Lead sponsor: Zamar Fisioterapia
Sponsor class: OTHER
Collaborators: name: Hospital San Juan de Dios, Spain
name: Universidad de Murcia
First posted: 2021-06-09
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief 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 Ambispective observational study of 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 of orthogeriatrics for 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.

Detailed description: This research project is intended to be carried out in the Functional Recovery Unit integrated in the Orthogeriatrics Service of the San Juan de Dios Hospital 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 collected participants will be informed of the purpose of the study and their written informed consent will be requested.

Description of the process:

* Candidate selection: the patient will be cared for by orthogeriatrics unit according 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 patient is 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: 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 with osteoporotic hip fracture in 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.

Subsequently, the patient will be informed of 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.

Profiles of patients whose clinical circumstances permit, a corroborated history should be taken, including:

* Premorbid function and mobility.
* Available social support (including whether the patient already has a caregiver or whether someone is willing and able to provide such support)
* Relevant current clinical conditions
* State of mind.

  * Hip Surgery.
  * Recovery programme (protocol of action that replaces the usual practice developed previously):
* 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. This programme is part of the standard treatment protocol implemented since January 2021 by the Orthogeriatrics Unit of the San Juan de Dios Hospital.

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 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 platform to 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 Statistical Package for the Social Sciences programme. The mean, median and standard deviation of each of the variables will be calculated. Based on the data obtained from the existing literature, 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 qualitative will 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.

Eligibility criteria: Inclusion Criteria:

* Patients referred from the Emergency Service of the León Assistance Complex (CAULE), confirmation of the medical diagnosis of hip fracture by means of Antero-Posterior and Lateral radiography.
* Be over 65 years of age.
* Be able to walk before the fracture with or without the help of instruments or people.
* Have signed the informed consent to participate in the research project.
* With access to a mobile phone with the option to install applications.

Exclusion Criteria:

* Multiple trauma patients will be excluded.
* Metastatic origin of the fracture.
* Periprosthetic fracture.
* Patients with cognitive impairment that makes it impossible for them to use a mobile phone with applications and who are not accompanied by a responsible person during the recovery process.

Primary outcomes:
measure: Functional Ambulation Classification-1d.
timeFrame: First day
measure: Functional Ambulation Classification-3dQX.
timeFrame: 3 days after surgery
measure: Functional Ambulation Classification-6W.
timeFrame: 6 weeks
measure: Functional Ambulation Classification-16W.
timeFrame: 16 weeks
measure: Functional Ambulation Classification-1Y.
timeFrame: 1 year
Secondary outcomes:
measure: Short Portable Mental Status Questionnaire 1d
timeFrame: First day
measure: Short Portable Mental Status Questionnaire 3dQx
timeFrame: 3 days after surgery
measure: Mobility prior to the fracture, according to the Spanish national registry of hip fractures due to fragility 1d.
timeFrame: First day
measure: Mobility prior to the fracture, according to the Spanish national registry of hip fractures due to fragility 3dQx.
timeFrame: 3 days after surgery
measure: Mobility prior to the fracture, according to the Spanish national registry of hip fractures due to fragility 6W.
timeFrame: 6 weeks
measure: Mobility prior to the fracture, according to the Spanish national registry of hip fractures due to fragility 16W.
timeFrame: 16 weeks
measure: Mobility prior to the fracture, according to the Spanish national registry of hip fractures due to fragility 1Y.
timeFrame: 1 year
measure: Barthel Index 1d.
timeFrame: First day
measure: Barthel Index 3dQx
timeFrame: 3 days after surgery
measure: Barthel Index 6W
timeFrame: 6 weeks
measure: Barthel Index 16W
timeFrame: 16 weeks
measure: Barthel Index 1Y
timeFrame: 1 year
measure: SARC-F questionnaire (Sarcopenia Screening) 1d
timeFrame: First day
measure: SARC-F questionnaire (Sarcopenia Screening) 3dQx
timeFrame: 3 days after surgery
measure: SARC-F questionnaire (Sarcopenia Screening) 6W
timeFrame: 6 weeks
measure: SARC-F questionnaire (Sarcopenia Screening) 16W
timeFrame: 16 weeks
measure: SARC-F questionnaire (Sarcopenia Screening) 1Y
timeFrame: 1 year
measure: Oxford Hip Score 1d
timeFrame: First day
measure: Oxford Hip Score 3dQx
timeFrame: 3 days after surgery
measure: Oxford Hip Score 6W
timeFrame: 6 weeks
measure: Oxford Hip Score 16W
timeFrame: 16 weeks
measure: Oxford Hip Score 1Y
timeFrame: 1 year
measure: STRATIFY 1d.
timeFrame: First day
measure: STRATIFY 3dQx
timeFrame: 3 days after surgery
measure: STRATIFY 6W
timeFrame: 6 weeks
measure: STRATIFY 16W
timeFrame: 16 weeks
measure: STRATIFY 1Y
timeFrame: 1 year
Other outcomes:
Locations:
city: León
country: Spain
facility: Hospital San Juan de Dios de León
state: Castilla Y León
Study officials:
affiliation: Centro Universitario San Rafael
name: Joaquín Zambrano Martín, MSC PT
role: PRINCIPAL_INVESTIGATOR
References: