NCT05393362Completed
Effectiveness of a Cardiac Rehabilitation Program in Elderly Patients With Heart Failure.
Effectiveness of a Cardiac Rehabilitation Program on Biomechanical, Imaging, and Physiological Biomarkers in Elderly Patients With Heart Failure.
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
The main objective of the study is to assess the effectiveness of a cardiac rehabilitation program on functionality, measured by kinematic analysis, cardiorespiratory capacity, and ventricular ejection fraction in elderly patients with heart failure (HF). Other objectives will be; 1) to validate the kinematic analysis as an objective functional assessment that allows performing a functional stratification based on the severity of impairment ("kinematic phenotypes"), as well as to identify those patients who responders or are not responders to the cardiac rehabilitation program; 2) to develop a functional index that includes objective functional parameters, biomechanical biomarkers (heart and musculoskeletal echography) and physiological biomarkers (maximum consumption of oxygen (VO2 max), maximum heart rate (HR max) and blood lactate levels; 3) to analyse the degree of concordance of biomechanical biomarkers with functional tests normally used in clinical practice and with imaging and physiological biomarkers. A randomized, controlled, crossover clinical trial will be carried out at the Hospital Regional Universitario de Málaga. Clinically stable HF patients ≥70 years old will be included. The cardiac rehabilitation program will last 12 weeks and will follow the recommendations of the European Association of Cardiovascular Prevention and Rehabilitation. The patients will perform different functional tests, which will be at baseline, at 3 months and 6 months of follow-up.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 65 (actual)
- First submitted
- 16 May 2022
- Start date
- 7 Mar 2023
- Primary completion date
- 1 Jul 2025
- Lead sponsor
- University of Malaga
- Diseases
- Heart failure
- NCT number
- NCT05393362
What you commit to
- Study type: Interventional
- Participants enrolled: 65
- From 7 Mar 2023 to the primary completion date, 1 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participants with cardiac pathologies that do not have an HF situation
Other
- Score on the NYHA scale equal to 4.
- Hospitalization in a period of time equal to or less than 3 months.
- Score on the Mini-Mental scale (MMSE) below 24.
- Inability to get up from the chair at least 5 times
- Inability to walk.
- Inability to walk independently without a gait assist device (cane, crutch, or walker).
- Participation in an experimental study where they receive treatment.
- Inability to provide informed consent.
Who the study is looking for
- Subjects older than 70 years.
- Subjects diagnosed with Heart Failure (HF) followed by the Heart Failure Unit.
- Subjects will be able or filling out questionnaires and perform functional tasks;
- Clinical stability.
- Patients receive optimal treatment.
Age in the registry: 70 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Antonio Cuesta Vargas Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.