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Enrolling by Invitation

NCT Number: NCT07373119

Improving Frailty in Patients With Stable Ischemic Heart Disease

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.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Frailty Heart Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Primary Care Centers

Barcelona, Select..., 08007, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiotherapy

Other

Primary care based physiotherapy groups

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Registry information

Official study title

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

Acronym: FRAGICOR

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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