Impact of Cardiac Rehabilitation Adapted for Patients With Heart Failure (RAP-IC)

Majadahonda Iron Gate University

Status: Not yet enrolling

Conditions: Heart Failure

Treatments: Other: Cardiac rehabilitation program

Study type: Interventional

Funder types: Other

Identifiers

NCT07350941

PI 195/25

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Cardiac rehabilitation group (treatment group)

Experimental group

Description:

3 months of a 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:

Other: Cardiac rehabilitation program

No intervention group

No Intervention group

Description:

General exercise and educational recommendations