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Enrolling by invitation NCT07373119

Improving Frailty in Patients With Stable Ischemic Heart Disease

No phase Interventional Coronary Heart Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: physiotherapy.
Who it may be relevant to
Registry conditions: Coronary Heart Disease. Basic parameters: from 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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

Interventions

  • Other physiotherapy
    Primary care based physiotherapy groups

Primary outcome measures

  • Short Physical Performance Battery (SPPB) components (balance, gait speed, chair rise) [Time frame: From enrollment to the end of treatment ending after 12 weeks.]
Secondary outcome measures (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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Spain · 1 center
  • Primary Care Centers — Barcelona

Identifiers

NCT: NCT07373119 · ethics committee 25/198-P · Ajuts XB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗