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Cardiac Rehabilitation Program in Patients with Cardiovascular Disease

StatusUnknown
PhaseNot applicable
Started
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Record History

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  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Active, Not Recruiting
  2. Minor Trial status: Not Yet Recruiting to Active, Not Recruitingv3 Show 4 more changesShow less
    • Primary completion date changed from estimate of Nov 30, 2024 to Jul 30, 2024
    • Study completion date: Dec 30, 2024 to Oct 30, 2024
    • Start date changed from estimate of Sep 8, 2024 to Jul 10, 2024
    • Site details revised
  3. Notable Primary completion date: Mar 30, 2024 to Nov 30, 2024v2 Show 4 more changesShow less
    • Start date: Jan 8, 2024 to Sep 8, 2024
    • Study completion date: Mar 30, 2024 to Dec 30, 2024
    • Secondary endpoints revised (39)
    • Study description expanded, about 2 words
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This protocol study aims to evaluate the effectiveness of a cardiac rehabilitation intervention program in patients with cardiovascular diseases to improve both anthropometric and biochemical data, as well as other variables related to cardiovascular disorders (cardiorespiratory fitness, muscle strength, …), and emotional aspects (anxiety, depression). Additionally, this study aims to evaluate the effectiveness of the cardiac rehabilitation program in improving body composition (waist circumference and body fat percentage), blood pressure and health-related quality of life. Objectives: i) To assess the functional capacity of patients with a recent cardiovascular event (acute coronary syndrome, onset heart failure, valve or bypass surgery) or with chronic decompensated cardiovascular disease (valvulopathy, pulmonary hypertension, congenital heart disease, heart failure) chronic), ii) to determine the different cardiorespiratory parameters obtained from cardiopulmonary exercise testing (CPET), iii) to determine the lifestyle habits and cardiovascular risk factors, iv) to develop a cardiac rehabilitation program according to and adapted to the need of each of these patients, v) to estimate the effect of the intervention, both in the muscle strength and in post-intervention CPET, biochemical and anthropometric parameters, v) to estimate the effect of the intervention in the quality of life, anxiety, depression, and adherence to the Mediterranean diet.
Trial Details
NCT Number NCT06211361
Lead Sponsor University of Castilla-La Mancha
Collaborators: Hospital Virgen de la Luz
Conditions
(from sponsor)
Cardiovascular Diseases
Related terms Cardiovascular Diseases, Heart Failure, Myocardial Ischemia
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov