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Impact of Cardiac Rehabilitation Adapted for Patients With Heart Failure

ConditionHeart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorPuerta de Hierro University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cardiac rehabilitation program

    Other intervention

    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.

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: Cardiac rehabilitation group (treatment group)Experimental treatment 1 intervention
Group B: No intervention groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Primary Endpoint: Change in Peak Oxygen Uptake

Change in peak oxygen uptake measured by treadmill cardiopulmonary exercise testing (peak VO₂, measured in ml/kg/min).

Time frame
3 months

Secondary outcomes

1

Change in Functional Permormance assessed by the Short Physical Performance Battery (SPPB) score

Change in the Short Physical Performance Battery (SPPB) score, ranging from 0 (worst physical performance) to 12 (best physical performance).

Time frame
3 months
2

Change in the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) score

Change in the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) overall summary score, ranging from 0 (worst health status) to 100 (best health status)

Time frame
3 and 6 months
3

Change in distance walked (meters) in the 6-Minute Walk Test (6MWT).

Change in distance walked (meters) in the 6-Minute Walk Test (6MWT).

Time frame
3 and 6 months
4

Change in caregiver burden assessed by the Zarit scale

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)

Time frame
3 and 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Puerta de Hierro University Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: