Improving Frailty in Patients With Stable Ischemic Heart Disease (FRAGICOR)

January 22, 2026 updated by: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Impact of a Program Aimed at Improving Frailty in Patients With Stable Ischemic Heart Disease in Primary Care: Fragicor Study

The goal of this clinical trial is to improve the frailty in old patients who have a cardiac disease .

Researchers will determine the improvement in the instability and the strength along twelve sessions based on guided exercises and mobility techniques made by physiotherapists. Research team will also evaluate the medications and diet, as well as laboratory and clinical tests.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Intitial visit to measure quality of life, instability and strenght, followed by twelve sessions, one each week will be performed

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Select...
      • Barcelona, Select..., Spain, 08007
        • Primary Care Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with stable coronary heart disease
older than 70 years, idependents in ADL
Other: physiotherapy
Primary care based physiotherapy groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Physical Performance Battery (SPPB) components (balance, gait speed, chair rise)
Time Frame: From enrollment to the end of treatment ending after 12 weeks.
Improvement in baseline values: each of the three component scores <= 4 points, and tests consists of: balance test, Gait speed and chair-stand tests. Maximum possible is 12 points and under 10 points means frailty
From enrollment to the end of treatment ending after 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Euroqol5D Goldberg Anxiety and Depression Scale Number of falls throughout the study Major Cardiovascular events Adherence to the program
Time Frame: from the baseline to 12 weeks of intervention

Euroqol5D measures the Quality of life through an Analogic Visual Scale, which ranks from 0 (worst) to100(best) Goldberg anxiety and depression scales measure the probabilty of suffering from anxiety or depression. The tests consist in a total of 9 questions for each dimension. A score of >=4 in any of the dimensions suggest pathology.

Adherence to the program will be evbaluated counting the attendance to the sessions. More than 9 sessions will be considerated good adherence
from the baseline to 12 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Actual)

December 30, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ethics committee 25/198-P
  • Ajuts XB (Other Grant/Funding Number: Catalan Institute of Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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