Impact of a Program Aimed at Improving Frailty in Patients With Stable Ischemic Heart Disease in Primary Care: Fragicor Study
Phase: NA
Conditions: Coronary Heart Disease
Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

FRAGICOR Study Protocol –  
Impact of a  Program Aimed at Improving Frailty in Patients with Stable Ischemic 
Heart Disease in Primary Care: Fragicor Study 
 
 
Brief title:  Improving Frailty in Patients with Stable Ischemic Heart Disease 
Date: 01/22/2026 
PI: Miguel Angel Muñoz 
 
 

 
SUMMARY 
 
The progressive aging of the population leads to an increase in frailty, with the 
consequent risk of falls, hospitalization, and institutionalization. Frailty has been 
described as an important predictor of falls, disability, and mortality in older adults. 
People with frailty have a higher prevalence of coronary heart disease, which is 
especially relevant given the greater risk of bleeding associated with falls in these 
patients. 
Lifestyle‑based interventions — such as physical exercise and nutrition — as well as the 
management of chronic diseases, may be effective in preventing adverse events. 
Objectives: We propose a multimodal before‑and‑after interventional study in a 
population aged 70 years and older with stable ischemic heart disease, aiming to 
improve frailty and reduce the risk of falls. The study will be conducted in five primary 
care centers in Barcelona. Patients will be selected by the healthcare professionals 
responsible for their care, and the intervention will be delivered by their physicians, 
nurses, and physiotherapists. 
After verifying inclusion and exclusion criteria, patients will sign the informed consent 
and participate in twelve physiotherapy sessions, being assigned to specific frailty 
groups. Sociodemographic and clinical variables will be recorded, and specific frailty 
tests will be administered at baseline and at the end of the study. Measurements will be 
compared after twelve sessions. At the end of the intervention, a recommendation sheet 
will be provided to participants. Three months after completing the intervention, 
frailty‑related variables will be reassessed, and adherence to recommendations. The 
research team will have access to clinical records for up to 6 months to ensure all 

variables are documented. Descriptive statistics will be performed, and pre‑post values 
will be compared using the paired t‑test for normally distributed data and the Wilcoxon 
signed‑rank test for non‑parametric data. Qualitative variables will be expressed as 
absolute frequencies and percentages, and compared using McNemar’s test. 
The protocol has been submitted for approval to the Ethics Committee of the IDIAP Jordi 
Gol Research Institute and has been agreed upon by the research team and the 
management of all participating centers. 
 
 
INTRODUCTION 
The population attended in primary care is increasingly older and presents greater 
comorbidity. This situation leads to an increase in frailty and its associated risks: falls, 
hospitalization, and institutionalization (1). Frailty has been identified as an important 
predictor of falls, disability, and mortality in older adults (2). Its prevalence increases with 
age and ranges between 12% and 45% among individuals over 65 years, depending on 
whether they live in the community or in institutionalized settings (3,4). 
 
The World Health Organization defines frailty as “an age‑related decline in physiological 
systems that results in decreased intrinsic capacity reserves, conferring greater 
vulnerability to stressors and increasing the risk of adverse health outcomes” (5). Early 
detection has proven effective in achieving reversibility in its initial stages. The 
ADVANTAGE Joint Action, involving 22 EU member states and 38 organizations, 
recommends the Short Physical Performance Battery (SPPB) for early diagnosis (6). 
 
 

The Spanish National Health System’s consensus on frailty and fall prevention 
recommends opportunistic screening for frailty in individuals over 70 years old who are 
not dependent (Barthel ≥ 90 points) in primary care (7). 
 
Lifestyle‑based interventions — such as physical exercise and nutrition — along with 
optimal management of chronic diseases, have proven effective in preventing adverse 
outcomes (8). Among these, exercise‑based interventions focusing on strength training 
show the best results, outperforming aerobic training, with superior benefits when 
performed in group settings rather than individually (1). 
 
The SPRINTT study concluded that in patients with SPPB scores between 3 and 7, a 
complete multimodal intervention reduced disability, particularly in women (9). 
 
Additionally, it is known that frail older adults have a higher prevalence of coronary heart 
disease (10). The EPESE study demonstrated a two‑fold higher risk of coronary 
mortality when coronary disease coexisted with impaired mobility (11). 
 
One of the pillars of secondary prevention in ischemic heart disease is low‑dose 
antiplatelet therapy (12), yet this treatment carries bleeding risks (13), making falls 
particularly severe. Furthermore, dual antiplatelet therapy with aspirin and clopidogrel 
should not extend beyond one year after the acute episode (14). 
 
Frailty also increases the risk of bleeding in patients with acute coronary syndrome (15). 
The clinical picture becomes even more complex when atrial fibrillation coexists with 
ischemic heart disease. Atrial Fibrillation (AF) incidence among patients with ischemic 
heart disease ranges from 6–21% (16), while 20–30% of AF patients will develop 

ischemic heart disease (17), often requiring concurrent anticoagulant and antithrombotic 
therapy, increasing bleeding risk. 
 
Therefore, it is essential to identify patients with ischemic heart disease at high risk for 
frailty and to implement strategies to prevent or improve frailty when already present — 
both due to the intrinsic consequences of frailty and its specific prognostic impact in this 
population. 
 
 
 

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HYPOTHESIS 
1. The application of a multimodal frailty-prevention program may be effective in 
reducing frailty in patients with stable coronary artery disease. 
2. The application of a multimodal frailty-prevention program may be effective in 
reducing the risk of falls in patients with stable coronary artery disease. 
3. The application of a multimodal frailty-prevention program may improve muscle 
strength in patients with stable coronary artery disease. 
4. The application of a multimodal frailty-prevention program may improve quality of 
life in patients with stable coronary artery disease. 
5. The application of a multimodal frailty-prevention program may improve clinical 
and laboratory parameters in patients with stable coronary artery disease. 
6. The improvements obtained may be maintained three months after completion of 
the in-person intervention. 
 
OBJECTIVES 
General Objective 
To evaluate the effect of a multimodal preventive intervention consisting of group 
physiotherapy sessions, nutritional recommendations, and medication review on frailty 
parameters in a group of patients aged 70 years and older with stable ischemic heart 
disease. 

Specific Objectives 
1. To analyze whether the application of an intensive group program to address 
frailty in patients with stable ischemic heart disease leads to a lower risk of falls. 
2. To determine whether this program is accompanied by an improvement in 
muscle strength. 
3. To evaluate changes in quality of life perceived by patients as a result of the 
program. 
4. To assess changes in clinical and laboratory parameters in these patients. 
5. To determine whether the results obtained are maintained three months after 
completion of the in-person intervention. 
 
DESIGN 
Experimental before-and-after study in which the effect of a multimodal preventive 
intervention on frailty parameters will be evaluated in a group of patients with stable 
ischemic heart disease. 
 
INCLUSION CRITERIA 
 
Age ≥ 70 years  
 
Diagnosis of coronary artery disease (International Classification Diseases (ICD)-
10 I20–I25)  
 
Canadian Cardiovascular Society Class I 
 
Low cardiovascular risk according to exclusion criteria 

 
Barthel Index ≥ 90 
EXCLUSION CRITERIA 
(adapted from the SPRINTT study)  
 Inability or refusal to provide informed consent (advanced dementia, 
severe psychiatric illness) 
 Inability to perform protocol procedures  
 Severe mobility-limiting conditions (Parkinson’s disease, progressive 
neurological disorders, disabling joint disease)  
 Recent (<6 months) unstable angina, myocardial infarction, coronary 
revascularization or angioplasty  
 Deep venous thrombosis or pulmonary embolism in the last 6 months  
 Recent stroke (<6 months) 
 Heart failure  in New York Heart Assocaition functional status (NYHA)  III-
IV 
 Left ventricular ejection fraction < 50% 
 
Symptomatic valvular heart disease 
 
 
 

SAMPLE SIZE (BEFORE–AFTER, MATCHED MEANS IN A SINGLE GROUP) 
Accepting an alpha risk of 0.05 and a statistical power >0.8 in a two-sided test, at least 
63 subjects are required to detect as statistically significant a difference ≥1 point on the 
SPPB scale. A common standard deviation of 2.7 is estimated. A 10% loss to follow-up 
is assumed. (Pandey A et al. JAMA Cardiol. 2023) (21–23). 
 
SETTING AND SAMPLE SELECTION 
The physician responsible for the patient will generate a list of potential participants 
based on the diagnosis (ICD-10 I20–I25) and age (≥70 years). 
The physiotherapist may also identify patients from lists of individuals with ischemic 
heart disease who have already been treated. 
The family physician or the physiotherapist at the reference Primary Care Center (CAP), 
if the physician delegates, will call the patient by phone for the inclusion visit, informing 
them about the study. Participants will be selected using consecutive sampling from the 
lists until the required sample size is reached. 
Distribution of sample size among centers: 
 
Primary Healthcare Center (PHC)  Adrià: 16 patients (2 physiotherapists) 
 
(PHC)   Pare Claret: 16 patients (2 physiotherapists) 
 
(PHC)   Passeig de Sant Joan: 12 patients (1 physiotherapist) 
 
(PHC)   Sant Martí de Provençals: 24 patients (3 physiotherapists) 
 
(PHC)   La Mina: 16 patients (2 physiotherapists) 

The physician will evaluate the patient, verify inclusion and exclusion criteria, and 
request any complementary tests needed to complete baseline data. 
Patients who meet the inclusion criteria and sign the informed consent will be referred to 
the physiotherapist. It will be recorded in the patient’s medical record that they have 
signed the consent. 
The consent forms will be centralized at the Barcelona Research Support Unit. 
The physiotherapist will arrange a first appointment at which they will assess each 
participant’s frailty parameters. Once the required number of patients has been reached 
for each group, they will schedule the group sessions. 
The physiotherapist will inform the physician about the results of the tests for their 
patients, in case the physician considers it appropriate to intervene. 
OUTCOME VARIABLES 
 
Variable name 
Type 
Instrument / scale 
Time points (visits) 
Coding / 
units 
Gerontopole score 
Quantitative 
Gerontopole Frailty 
Screening Tool 
(seven questions) 
Baseline, post-
intervention, 3 months 
1 or more 
questions 
means frailty  
SPPB total score 
Quantitative 
Short Physical 
Performance Battery 
Baseline, post-
intervention, 3 months 
 <10 points 
means frailty 
SPPB components 
Quantitative SPPB subtests 
Same as above 
0–4 points 

Variable name 
Type 
Instrument / scale 
Time points (visits) 
Coding / 
units 
(balance, gait speed, 
chair rise) 
measured in seconds 
to perform the prove 
each 
Handgrip strength 
Quantitative 
GRIPX digital hand 
dynamometer 
Baseline, post-
intervention, 3 months 
kg (best of 2 
attempts) 
Goldberg anxiety score 
Quantitative 
Goldberg Anxiety 
and Depression 
Scale (9 questions) 
Baseline, post-
intervention, 3 months 
>=4 afirmative 
questions 
means anxiety 
Goldberg depression 
score 
Quantitative 
Goldberg Anxiety 
and Depression 
Scale (9 questions) 
Baseline, post-
intervention, 3 months 
>=4 afirmative 
questions 
means 
depression 
EuroQol  
Visual Analogic Scale 
Quantitative EQ-5D VAS 
Baseline, post-
intervention, 3 months 
0–100 
Number of falls 
Count 
Patient report / 
calendar 
During intervention, 3-
month follow-up 
Count 
Major Adverse 
Cardiovascular Events 
(MACE) / angina 
Binary 
Clinical record 
Throughout study 
0 = no, 1 = 
yes 
(withdrawal) 
Adherence to home 
program 
Quantitative Exercise calendar 
3-month follow-up 
Number of  
sessions 
attended 
 

Changes in the following variables will be evaluated with respect to their baseline values: 
Gerontopole Frailty Screening Tool (first and last visit) 
This is a tool designed to identify frail older people in primary care, allowing early 
detection and the implementation of preventive and personalized care strategies. 
It assesses 6 parameters: weight loss, fatigue, gait speed, loss of mobility, memory 
complaints, and living alone. It also includes a subjective question for the healthcare 
professional. 
 
Record the score for each item. 
 
Calculate the total score. 
SPPB Scale (Short Physical Performance Battery) – First and last visit 
It measures balance, gait speed, and lower-limb strength. 
 
Record the total number of seconds in each exercise and categorize it according 
to the validated instructions of the test. 
Balance test: 
If the patient maintains the position for more than 10 seconds, record up to a maximum 
of 20 seconds. 
Gait speed and chair-stand tests: 
If the patient exceeds the maximum times (>8.70 and >60 seconds, respectively), do not 
insist on continuing the test and assign the corresponding score according to the scale. 

Hand Grip Strength (Dynamometer) 
Recorded at the first and last visit (best of two attempts). Measures isometric handgrip 
strength in kilograms. 
Goldberg Anxiety and Depression Scale 
First and last visit. 
Number of falls throughout the study 
EuroQol-5D 
First and last visit. 
Major Adverse Cardiovascular Events (MACE) or angina 
(Reason for withdrawal from the study). 
 
INDEPENDENT VARIABLES 
 
Variable name 
Type 
Source 
Time point 
Coding / units 
Age 
Quantitative 
Clinical record 
/ interview 
Baseline 
Years 
Sex 
Categorical 
Clinical record Baseline 
Female / Male / Non-binary 
Sistolic blood 
pressure / 
Quantitative 
Blood pressure 
measurement 
Baseline, 3 
months 
mmHg 

Variable name 
Type 
Source 
Time point 
Coding / units 
Diastolic blood 
Pressure 
Heart rate 
Quantitative 
Clinical record Baseline 
bpm 
Hemoglobin 
Quantitative 
Laboratory 
Baseline, 3 
months 
g/dL 
Red blood cell 
count 
Quantitative 
Laboratory 
Baseline, 3 
months 
10^6/µL 
Glucose 
Quantitative 
Laboratory 
Baseline, 3 
months 
mg/dL 
Glycated 
haemoglobin 
Quantitative 
Laboratory 
Baseline, 3 
months 
% 
Total cholesterol 
Quantitative 
Laboratory 
Baseline, 3 
months 
mg/dL 
Low density 
Lipoprotein  
cholesterol 
Quantitative 
Laboratory 
Baseline, 3 
months 
mg/dL 
High density 
Lipoprotein  
cholesterol 
Quantitative 
Laboratory 
Baseline, 3 
months 
mg/dL 
Transaminases 
Quantitative 
Laboratory 
Baseline, 3 
months 
U/L 
Glomerular 
Quantitative 
Laboratory 
Baseline, 3 
mL/min/1.73m² 

Variable name 
Type 
Source 
Time point 
Coding / units 
filtration 
months 
Comorbidities 
Categorical 
Clinical record Baseline 
(yes/no) 
Medication  
Categorical 
Medication list Baseline 
Betablockers, 
renne/angiotensine 
inhibitors, Calcium cannel 
blockers, diuretics, 
antiplatelets, 
 
 
 
 
 
 
ETHICAL ASPECTS 
Eligible candidates will sign the informed consent form. All procedures will be explained 
to participants in detail. 
The informed consent form includes a statement allowing the investigating physicians on 
the team to review participants’ medical records throughout the study to identify clinical 
events and extract data relevant to this research. All personal data collected for the 
study will always be used in anonymized form (see below). 

There is no potential ethical conflict regarding confidentiality when identifying suitable 
candidates or reviewing medical records, since these tasks are exclusively assigned to 
the physicians responsible for the participants’ care. 
There are no potential conflicts of interest among the members of the research team. 
Data recorded, both from the medical record and from face-to-face visits, will be entered 
in coded form into a data collection sheet stored at each participating center, which will 
be sent regularly to the Barcelona Research Support Unit, where the information will be 
centralized. When a participant meets criteria compatible with those for exclusion, they 
will be immediately withdrawn from the study and their physician will be informed. If they 
present chest pain or symptoms compatible with acute coronary syndrome, urgent 
clinical protocols will be activated and their physician will be informed as soon as 
possible. In that case, the participant will be withdrawn from the study. 
When the project is completed, all collected information will be destroyed five years later. 
The results will be presented in aggregate form in reports and written publications, 
always anonymously, so their name or any other identifying information will be removed. 
Physiotherapists will inform the physicians responsible for the patients of any issues that 
may influence therapeutic management during the study. 
The principal investigators will assess the outcome variables at the end of the study. 
The reference healthcare professionals are responsible for proposing participation in the 
study to selected individuals, explaining the type of study that is to be carried out, and 
obtaining their written informed consent. All data will be obtained through interview, 
physical examination, and review of the medical record. 

The study will be conducted in accordance with the latest revision of the Declaration of 
Helsinki (2013): 
https://www.idiapjgol.org/images/investigacion/declaracion_helsinki_2013.pdf 
Likewise, the Code of Good Research Practice in Primary Care Research of IDIAP Jordi 
Gol (2015) will be followed. The protocol has been approved  by the IDIAP Jordi Gol 
Research Ethics Committee (CEI) (Reference Number: 25/198-P). 
The investigators undertake to maintain data confidentiality and not to use the data for 
any other purpose. 
Confidentiality of Data 
The European Union legislation on personal data will be observed, in particular 
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 
2016 on data protection, as well as Spanish Organic Law 3/2018 of 5 December on 
Personal Data Protection and guarantee of digital rights. 
Information will be recorded in coded form and stored in a password-protected Excel 
database on computers belonging to the Catalan Health Institute (ICS). The data 
required to decode the information will be kept in a separate, password-protected file 
accessible only to the investigators. 
Use of Data 
 
Identification of data and individuals processing them. 
The variables needed for the study come from interviews conducted with 
informed consent, which includes access to the data recorded in the electronic 
medical record (e-CAP). Information will be recorded in coded form and stored in 
a protected Excel database on ICS computers, and the data required for 

decoding will be in another password-protected file accessible only to the 
investigators. The Catalan Health Institute will act as the data controller in the 
context of this study, and the project database will be hosted on ICS servers. 
 
Identification of uses and legal basis. 
The variables necessary to carry out the study will be obtained directly from 
project participants and from review of their clinical records with their consent. 
 
Tools used for data processing. 
Project data will be stored on the institution’s servers. 
 
International data transfers. 
No international transfer of data is planned. 
 
High-risk data processing. 
The project does not meet the conditions that would require a specific Data 
Protection Impact Assessment. 
 
Information sheet and consent form content. 
The participant information sheet and consent form will include a section on data 
processing (see Annex). 
 
POTENTIAL HEALTH RISKS FOR PARTICIPANTS 
The activities planned in the group sessions are not expected to increase participants’ 
risk, nor do they differ from those already carried out in existing frailty groups. Health, 
physical strength, balance, and quality of life are expected to improve during the 
intervention. As participants are in a stable phase of their disease, no adverse effects 
related to the intervention are expected. 

This is not a cardiac rehabilitation project, as it will only include clinically stable patients 
who have not experienced a cardiovascular event in the previous six months. 
 
 
STATISTICAL ANALYSIS 
A before-and-after design will be used to evaluate changes in the variables of interest 
after the intervention. 
Quantitative variables will be summarized using means and standard deviations when 
normally distributed, and medians and interquartile ranges when they are not. The 
normality of the variables will be assessed using the Shapiro–Wilk test. 
To compare the values before and after the intervention, the paired t-test will be used for 
normally distributed data, and the Wilcoxon signed-rank test for non-parametric data. 
Qualitative variables will be expressed as absolute frequencies and percentages, and 
compared using McNemar’s test. 
A statistical significance level of p < 0.05 will be adopted. 
A difference of 1 point on the SPPB scale will be considered clinically significant. A 
common standard deviation of 2.7 and a 10% loss to follow-up are assumed (Pandey A 
et al. JAMA Cardiol. 2023) (21–23). 
Data analysis will be performed using the R statistical software package. 
 

 
BUDGET 
The project starts without an assigned budget. 
However, during its development, the team plans to apply for competitive calls. 
This is a pilot project. Depending on the results obtained, the research team will consider 
applying for calls from the Instituto de Salud Carlos III and similar funding bodies. 
 
 
 
 
TIMELINE OF INTERVENTIONS 
 
Visit  
Responsible 
professional 
Timing 
Main activities / assessments 
Screening / Inclusion visit 
Family physician before intervention 
Eligibility, inclusion/exclusion, 
clinical history, consent, Barthel, 
ECG, labs 
Baseline physiotherapy visit Physiotherapist 
Week 0 
Gerontopole, SPPB, handgrip, 
Goldberg, EQ-5D, walking test, 
fall risk 

Visit  
Responsible 
professional 
Timing 
Main activities / assessments 
Group sessions 1–12 
Physiotherapist 
Weeks 1–12 (1 
session/week) 
Warm-up, aerobic training, 
strength, balance, cool-down 
Post-intervention 
physiotherapy visit  
Physiotherapist 
Week 12–13 
Gerontopole, SPPB, handgrip, 
Goldberg, EuroQool-5D, walking 
test; home program 
3-month follow-up 
physiotherapy visit 
Physiotherapist 
3 months after last 
session 
Adherence, falls, SPPB, 
handgrip, Goldberg, walking test, 
EuroQool-5D -5D 
3-month follow-up physician 
visit 
Family physician 
3 months after last 
session 
Clinical parameters (BP), labs, 
review of events 
Continuous follow-up 
(medical record review) 
Research team 
physicians 
Up to 6 months 
after intervention 
Recording MACE, angina, other 
relevant events 
 
BASELINE FAMILY PHYSICIAN VISIT 
After explaining the reason for the appointment, the physician will inform the patient 
about the objective of the study. 
They will verify that all variables required to start the study are available and request 
those not updated (older than six months). 
Medication review: 
Evaluate the appropriateness of chronic use of benzodiazepines, neuroleptics, first-

generation antihistamines, vasodilators, and opioids. Review cardiovascular treatments, 
including antiplatelets. 
Barthel Index (see Annex; https://www.samiuc.es/indice-de-barthel/) 
The physician will question the patient regarding exclusion criteria. 
Patients who meet all inclusion criteria and none of the exclusion criteria will receive the 
informed consent form and will be referred to the physiotherapist, who will conduct an 
interview and schedule the intervention sessions. 
 
 
 
 
PHYSICIAN RESPONSIBLE: _________ ID: _________ 
VERIFY INCLUSION CRITERIA (all three must be met) 
 
Age ≥ 70 years – YES / NO 
 
ICD-10 diagnosis (I20–I25) – YES / NO 
 
Barthel Index > 90 – YES / NO 
VERIFY EXCLUSION CRITERIA 
(Exclusion if any criterion is present) 
Recent cardiovascular disease < 6 months – YES / NO 
 
Unstable angina – YES / NO 

 
Myocardial infarction – YES / NO 
 
Coronary revascularization surgery / angioplasty – YES / NO 
 
Venous thrombosis / pulmonary thromboembolism – YES / NO 
 
Stroke – YES / NO 
 
Heart failure NYHA III–IV – YES / NO 
 
Documented ejection fraction < 50% – YES / NO 
 
Symptomatic valvular disease – YES / NO 
 
Uncontrolled severe arrhythmias – YES / NO 
 
Advanced peripheral arterial disease – YES / NO 
 
Advanced renal insufficiency (eGFR < 30) – YES / NO 
 
Severe depression or mental illness – YES / NO 
 
Institutionalized patients – YES / NO 
 
Life expectancy < 12 months – YES / NO 
 
Inability to participate in the study – YES / NO 
Biological sex 
 
Female / Male / Non-binary 
Check comorbidities: 
 
Ischemic heart disease I20–I25: 
o 
Record specific ICD-10 diagnosis (AMI, chronic ischemic heart disease, 
etc.) 
o 
Date of diagnosis (dd/mm/yyyy) 
o 
Date of last hospital admission or emergency visit (if not recorded, ask 
the patient) 

 
Previous stroke – YES / NO 
o 
If YES: date of diagnosis and date of last admission 
 
Peripheral arterial disease – YES / NO 
 
Hypertension – YES / NO 
 
Atrial fibrillation – YES / NO 
 
Chronic Obstructive Pulmonary Disease – YES / NO 
 
Diabetes mellitus – YES / NO 
 
Check if there is a laboratory test within the last 6 months 
(if not, request): 
Complete blood count, glucose, Glycosilated haemoglobine, transaminases, lipids, 
glomerular filtration rate 
Check if there are BP and BMI measurements within the last 6 months 
(if not, obtain them during the visit): 
 
Systolic blood pressure 
 
Diastolic blood pressure 
 
Body Mass Index 
Check if there is an Electrocardiogram from the last year (if not, request one): 
 
Present: YES / NO 
 
Severe arrhythmia: YES / NO 
 
Acute ischemia: YES / NO 
Medication review: 

Mark YES / NO for: 
 
Beta-blockers 
 
Antiplatelet agents 
 
Anticoagulants 
 
Calcium antagonists 
 
Renine-angiotensine inhibitors 
 
Diuretics (thiazide/loop) 
 
Sodium-glucose co-transporter 2 inhibitors  
 
Neuroleptics 
 
Benzodiazepines 
 
DIETARY RECOMMENDATIONS 
Provide dietary recommendations from the Spanish Heart Foundation (Fundación 
Española del Corazón): 
Available at: 
https://fundaciondelcorazon.com/phocadownload/recursos-
didacticos/dietas/Nuevas2021/DIETA%20ENFERMEDAD%20CORONARIA.pdf 
 
 
 

FIRST VISIT WITH THE PHYSIOTHERAPIST 
The first visit will focus on four areas: frailty, fall risk assessment, quality of life, and 
psychological distress. 
FRAILTY ASSESSMENT 
The physiotherapist will schedule the appointment, reinform the patient about the 
purpose of the study, and perform frailty screening. 
Actions: 
 
Gerontopole Frailty Screening Tool 
 
Short Physical Performance Battery (SPPB) 
During this visit, the time (in seconds) required to perform each activity will be recorded 
on a data collection sheet. 
 
Determination of grip strength using the GRIPX Digital Hand Dynamometer 
(automatic handgrip force meter). 
FALL RISK ASSESSMENT 
Falls Risk Scale (Spanish Consensus). 
According to the Spanish consensus guidelines for fall prevention (27), the patient will be 
asked: 
 
Have you had any fall in the last year that required healthcare attention? 
 
Have you had two or more falls in the last year? 

 
Do you have any gait disorder considered significant? 
(This question will be considered positive if the performance test used for frailty 
screening is abnormal; frailty according to SPPB). 
Interpretation: 
 
Negative answers to all three questions: Low risk 
 
Positive answer to any of the three questions: High risk 
Home fall risk factors will also be reviewed. 
QUALITY OF LIFE ASSESSMENT 
 
EuroQol-5D 
ANXIETY-DEPRESSION ASSESSMENT 
 
Goldberg Scale (see Annex) 
 
FACE-TO-FACE VISIT (INDIVIDUAL) –  (INITIAL PHYSIOTHERAPY VISIT) 
 
Gerontopole Frailty Screening Tool 
 
SPPB scale (record seconds with stopwatch as well as the categorical score) 
 
Goldberg anxiety/depression scale 
 
EuroQol-5D 
 
Walking Test (time in seconds) 
 
Handgrip strength (record numerically the best of two attempts) 
 

 
Structure and content of group physiotherapy sessions 
Session Duration Components 
Description / examples 
Target 
intensity 
(Borg) 
1 
50 min 
Introduction, 
education 
Group introduction, objectives, 
rules, therapeutic exercise 
principles, Borg scale 
– 
2–12 
50 min 
Warm-up 
Global mobility, joint range-of-
motion exercises 
3–4 
 
Aerobic 
component 
Walking, side steps, stepping 
up/down, adapted to patient 
characteristics 
3–4 
Interval training 20″ work / 15″ rest × 8 sets 
3–4 
Balance 
Static and dynamic balance 
exercises 
3–4 
Strength 
Upper and lower limb strengthening 
(with/without resistance) 
3–4 
Cool-down 
Stretching, breathing, relaxation ± 
simple game 
2–3 
 
 
 

 
 
INDIVIDUAL PHYSIOTHERAPY VISIT (FINAL) 
 
Gerontopole Frailty Screening Tool 
 
SPPB scale (record seconds and categorical score) 
 
Goldberg anxiety/depression scale 
 
EuroQol-5D 
 
Walking test (seconds) 
 
Handgrip strength (best of two attempts) 
Participants will be invited to continue an exercise program at home. 
They will receive recommendation sheets and will be asked to carry out the exercises 
twice a week. They will also be invited to record on a calendar the days on which they 
perform the activities and to bring it to the visit three months later. 
 
VISIT 3 MONTHS AFTER COMPLETING THE INTERVENTION 
PHYSIOTHERAPIST 
Will assess adherence to the program three months after the end of the intervention: 
 
Measure: number of days the agreed exercises were performed according to the 
calendar provided. 
 
Ask about number of falls. 

The following variables will be assessed: 
 
SPPB 
 
Hand dynamometry (handgrip) 
 
Goldberg scale 
 
Walking test 
 
EuroQol-5D 
FAMILY PHYSICIAN 
Clinical parameters: 
 
Systolic blood pressure (SBP) 
 
Diastolic blood pressure (DBP) 
Laboratory test  
 
 

ANNEXES 
 
SPPB scoring system: 
Balance (0–4 points), gait speed (0–4 points), chair-rise test (0–4 points); total 
(0–12 points). 
https://www.revespcardiol.org/es-recomendaciones-seccion-cardiologia-geri-
articulo-S0300893218303579 
 
Barthel Index 
 
Goldberg Anxiety and Depression Scale: 
https://www.redpal.es/wp-
content/uploads/2018/12/AnsiedadDepresio%CC%81nGoldberg.pdf 
 
EuroQol-5D 
 
Exercise scheme: 
o 
Warm-up 
o 
Balance 
o 
Strength work without resistance 
o 
Strength work with resistance 
 
Model of patient information sheet: including all paragraphs describing aims, 
voluntary participation, confidentiality, data protection, rights of 
access/rectification/erasure, and contact with investigators and Data Protection 
Officer, as per the original Spanish document. 
 
Informed consent model, including all YES/NO items about: 
o 
Having read the information sheet 
o 
Understanding risks and benefits 
o 
Voluntary nature of participation 
o 
Nature of physiotherapist-led visits 

o 
Confidentiality 
o 
Access to the clinical record by investigators 
o 
Communication of clinically relevant findings 
o 
Authorization for access to the clinical record for 6 additional months after 
the intervention 
With fields for: 
o 
Participant name and signature 
o 
Investigator name and signature 
o 
Date and place 
 
National falls prevention leaflet: 
https://www.sanidad.gob.es/areas/promocionPrevencion/lesiones/ocioHogar/doc
umentosTecnicos/docs/Prevenir_caidas_en_el_hogar.pdf 
 
 
 

INVESTIGATORS AND PARTICIPATING CENTERS 
GRECAP (PRIMARY CARE CARDIOVASCULAR RESEARCH GROUP) 
Name 
Role in the project 
Affiliation 
Mercè López Grau Principal Investigator 
PHC  Passeig de Sant Joan – 
GRECAP, ICS–IDIAP 
Miguel Angel 
Muñoz 
Co-Principal Investigator / 
Protocol lead 
PHC Joanic (Pare Claret) – GRECAP, 
ICS–IDIAP 
Jose María Verdú Co-investigator 
PHC Sant Martí de Provençals 
Ernest Vinyoles 
Co-investigator 
PHC La Mina 
Nuria Soldevila 
Co-investigator 
PHC La Mina 
Victoria Cendrós 
Co-investigator 
PHC Adrià 
José Luis del Val 
Methodology advisor 
Primary Care Management 
Deapartment, ICS Barcelona 
Elena Navas 
Statistician 
Priamry Care Research Unit Barcelona 
Miquel Gual 
Santandreu 
Cardiology advisor 
Hospital Sant Pau 
 
 
 

PHYSIOTHERAPISTS: 
(names and centers) 
 
Víctor Quartim Nobre – Passeig de Sant Joan 
 
Gema Duño Escagedo – Sant Martí 
 
Olga Bernat Rubio – Sant Martí 
 
Mercedes Orive Romero – Sant Martí 
 
Víctor Arias Alvarín – Adrià 
 
Mireia Fernández Meseguer – Adrià 
 
Natalia Blanco García – Joanic / Pare Claret 
 
Sergio García González – Joanic / Pare Claret 
 
Ferran Guitart Clermont – La Mina 
 
Marc Trujillo Pérez – La Mina 
Steering Committee: 
 
Mercè López 
 
Miguel Angel Muñoz 
 
PUBLICATION POLICY 
The publication of three articles in peer-reviewed journals is envisaged. 
The main article will analyze the effect of the intervention. 
Mercè López and Miguel Angel Muñoz are the originators of the project and have 
developed the protocol; therefore, they will appear as first and last authors, and 

corresponding author respectively, in all publications and communications derived from 
the study. 
In addition, three further GRECAP members will be listed as co-authors in the articles 
submitted for publication. If the journal allows it, four physiotherapists will be included as 
co-authors; if not, they will all be acknowledged in the Acknowledgments section. 
 
 

 

INFORMED CONSENT 
 
NAME AND SURNAME: 
ID Number:.... 
Postal Address... 
Email (if applicable)… 
Who informed you: 
Participant's Doctor:.... 
 
Please  select YES or  NO in the following qüestions: 
I have read the Patient Information Sheet, I understand the risks and benefits involved, that 
my participation is voluntary, and that I can withdraw or request the removal of my data 
and/or samples at any time. 
YES                   NO 
I understand that my participation in the study consists of visits by the physiotherapist at 
my health center to improve frailty. 
YES                   NO 
I understand that the study information will be confidential and that no unauthorized 
person will have access to the data or samples. 
YES                   NO 
I know how to contact the researchers if needed. 
YES                   NO 
I authorize the study doctors (unless there are any objections, this will be my doctor, who 
invited me to participate) to access my medical records for the duration of the study 
intervention and the analysis of the results. I authorize the research team to communicate 
to me any clinical data obtained during the study that is relevant to my health. 
YES                   NO 
I authorize the study physicians (unless there are any objections, this will be my own 
physician, who invited me to participate) to access my medical records annually for an 
additional six years after the study intervention has ended. 

YES                   NO 
Participant: Name and signature 
Researcher: Name and signature 
Date and Place