Impact of Cardiac Rehabilitation Adapted for Patients With Heart Failure
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: Cardiac rehabilitation program.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 65 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 →
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Official title
RAP-IC Study: Impact of Cardiac Rehabilitation Adapted for Patients With Heart Failure
Overview
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
- Other Cardiac rehabilitation program
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.
Primary outcome measures
- Primary Endpoint: Change in Peak Oxygen Uptake [Time frame: 3 months]
Secondary outcome measures (12)
- Change in Functional Permormance assessed by the Short Physical Performance Battery (SPPB) score [Time frame: 3 months]
- Change in the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) score [Time frame: 3 and 6 months]
- Change in distance walked (meters) in the 6-Minute Walk Test (6MWT). [Time frame: 3 and 6 months]
- Change in caregiver burden assessed by the Zarit scale [Time frame: 3 and 6 months]
- Change in body composition parameters assessed by bioelectrical impedance analysis (BIA) [Time frame: 3 and 6 months]
- Number of participants experiencing all-cause mortality, heart failure decompensation, or heart failure-related hospitalization during follow-up [Time frame: 3 and 6 months]
- Change in Frailty status assessed by FRAIL scale [Time frame: 3 and 6 months]
- Change in emotional status assessed by the Hospital Anxiety and Depression Scale (HADS) [Time frame: 3 and 6 months]
- Change in Nutritional Status assessed using the Mini Nutritional Assessment (MNA) score [Time frame: 3 and 6 months]
- Change in Maximal Inspiratory Pressure (MIP) [Time frame: 3 and 6 months]
- Patient satisfaction [Time frame: 6 months]
- Patient adherence [Time frame: 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital Universitario Puerta de Hierro — Majadahonda
Identifiers
NCT: NCT07350941 · PI 195/25