Heart Failure
Conditions
Keywords
Heart Failure, Cardiac rehabilitation, Cardiopulmonary stress test, Functional capacity
Brief summary
The aim of the study is to evaluate whether a tailored cardiac rehabilitation program, initiated during hospitalization and continued after discharge, can improve functional capacity, mobility, and quality of life in patients over 65 years old with heart failure.
Detailed description
If you meet the inclusion criteria and wish to participate, an initial assessment of your clinical and functional status will be conducted during your hospital stay. A computer system will then randomly assign you to one of the following groups: Cardiac Rehabilitation Group (treatment group): You will participate in a mild exercise program during hospitalization (Phase I), including mobility and respiratory exercises adapted to your clinical condition. After discharge, you will enter a structured in-person cardiac rehabilitation program (Phase II) lasting 3 months, consisting of two 1-hour exercise sessions per week (aerobic, strength, inspiratory, and proprioceptive exercises) plus one weekly educational session. Usual Care Group (control group): You will receive standard recommendations for physical activity and general care. At the end of the study, a final consultation will be conducted to assess differences between the two groups in functional capacity and quality of life.
Interventions
Cardiac rehabilitation program, in which patients will attend in person twice weekly (Mondays and Wednesdays or Tuesdays and Thursdays), in groups of up to 8 patients, for 1-hour exercise sessions including aerobic, resistance, respiratory, and balance/proprioceptive components. Sessions will be monitored and supervised by cardiologists, rehabilitation physicians, and physiotherapists. In addition, patients will attend one weekly in-person educational session throughout the 3-month program.
Sponsors
Puerta de Hierro University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients hospitalized for acute heart failure in a stable phase (on a stable dose or tapering intravenous diuretics for at least 48 hours, without intravenous inotropes or vasodilators for \>72 hours). * Baseline functional class II-III * Age ≥ 65 years * Able to walk \>4 meters * Any range of left ventricular ejection fraction
Exclusion criteria
* Moderate to severe dementia * Cardiac or other disease with a life expectancy \<12 months * Institutionalized patients or unable to travel to the rehabilitation center * Functional class I or IV * Uncontrolled arrhythmias * Inability to perform a basic exercise protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint: Change in Peak Oxygen Uptake | 3 months | Change in peak oxygen uptake measured by treadmill cardiopulmonary exercise testing (peak VO₂, measured in ml/kg/min). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Permormance assessed by the Short Physical Performance Battery (SPPB) score | 3 months | Change in the Short Physical Performance Battery (SPPB) score, ranging from 0 (worst physical performance) to 12 (best physical performance). |
| Change in the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) score | 3 and 6 months | Change in the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) overall summary score, ranging from 0 (worst health status) to 100 (best health status) |
| Change in distance walked (meters) in the 6-Minute Walk Test (6MWT). | 3 and 6 months | Change in distance walked (meters) in the 6-Minute Walk Test (6MWT). |
| Change in caregiver burden assessed by the Zarit scale | 3 and 6 months | Change in caregiver burden assessed by the 22-item Zarit Burden Interview (ZBI-22) score (range 0-88, with higher scores indicating greater caregiver burden) |
| Change in body composition parameters assessed by bioelectrical impedance analysis (BIA) | 3 and 6 months | Change in body composition parameters expressed as percentages (%), assessed by bioelectrical impedance analysis (BIA) |
| Number of participants experiencing all-cause mortality, heart failure decompensation, or heart failure-related hospitalization during follow-up | 3 and 6 months | All-cause mortality will be confirmed by medical records or death certificate. Heart failure decompensation will be defined as worsening of heart failure symptoms requiring urgent medical visit, treatment adjustment, or hospital admission. Heart failure-related hospitalizations will be collected from hospital records. Data will be aggregated as the number and percentage of participants experiencing each event during the study period |
| Change in Frailty status assessed by FRAIL scale | 3 and 6 months | Change in FRAIL scale (range 0-5, higher scores indicate greater frailty) |
| Change in emotional status assessed by the Hospital Anxiety and Depression Scale (HADS) | 3 and 6 months | Change in emotional status, measured using the Hospital Anxiety and Depression Scale (HADS), with subscales for anxiety and depression ranging from 0 to 21, where higher scores indicate greater symptom severity |
| Change in Nutritional Status assessed using the Mini Nutritional Assessment (MNA) score | 3 and 6 months | Change in nutritional status, assessed using the Mini Nutritional Assessment (MNA) score (range 0-30, with higher scores indicating better nutritional status) |
| Change in Maximal Inspiratory Pressure (MIP) | 3 and 6 months | Change in maximal inspiratory pressure (MIP) measured in cmH₂O, with higher values indicating greater respiratory muscle strength |
| Patient satisfaction | 6 months | Patient satisfaction with the cardiac rehabilitation program, rated from 0 to 10, being 10 the highest mark |
| Patient adherence | 3 months | Patient adherence to cardiac rehabilitation sessions, rated from 0 to 100%, being 100% the highest mark |
| Change in basic functional independence assessed by the Barthel Index | 3 and 6 months | Change in basic functional independence assessed by the Barthel Index (range 0-100, with higher scores indicating greater independence) |
| Change in maximal expiratory pressure (MEP) | 3 ad 6 months | Change in maximal expiratory pressure (MEP) measured in cmH₂O, with higher values indicating greater respiratory muscle strength |
Countries
Spain
Contacts
CONTACTMargarita Calvo-Lopez, MD
CONTACTJuan Carlos Lopez Azor, MD, PhD
PRINCIPAL_INVESTIGATORMargarita Calvo-LOpez, MD
Hospital Universitario Puerta de Hierro
Outcome results
None listed