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

RAP-IC Study: Impact of Cardiac Rehabilitation Adapted for Patients With Heart Failure

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Cardiac rehabilitation program

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.

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Margarita Calvo-Lopez, MD; Phone Number: +34637090285; Email: margarita.calvo@salud.madrid.org
• Study Contact Backup: Name: Juan Carlos Lopez Azor, MD, PhD; Phone Number: +34628026462; Email: lopez.gcia.juan.carlos@gmail.com

Study Locations

• Spain
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro
      • Contact: Margarita Calvo-Lopez, MD; Phone Number: +34637090285; Email: margarita.calvo@salud.madrid.org
      • Contact: Juan Carlos López Azor, MD, PhD; Phone Number: +34 628026462; Email: lopez.gcia.juan.carlos@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiac rehabilitation group (treatment group); 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.	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.
No Intervention: No intervention group; General exercise and educational recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3 months
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)	3 and 6 months
Change in distance walked (meters) in the 6-Minute Walk Test (6MWT).	Change in distance walked (meters) in the 6-Minute Walk Test (6MWT).	3 and 6 months
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)	3 and 6 months
Change in body composition parameters assessed by bioelectrical impedance analysis (BIA)	Change in body composition parameters expressed as percentages (%), assessed by bioelectrical impedance analysis (BIA)	3 and 6 months
Number of participants experiencing all-cause mortality, heart failure decompensation, or heart failure-related hospitalization during follow-up	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	3 and 6 months
Change in Frailty status assessed by FRAIL scale	Change in FRAIL scale (range 0-5, higher scores indicate greater frailty)	3 and 6 months
Change in emotional status assessed by the Hospital Anxiety and Depression Scale (HADS)	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	3 and 6 months
Change in Nutritional Status assessed using the Mini Nutritional Assessment (MNA) score	Change in nutritional status, assessed using the Mini Nutritional Assessment (MNA) score (range 0-30, with higher scores indicating better nutritional status)	3 and 6 months
Change in Maximal Inspiratory Pressure (MIP)	Change in maximal inspiratory pressure (MIP) measured in cmH₂O, with higher values indicating greater respiratory muscle strength	3 and 6 months
Patient satisfaction	Patient satisfaction with the cardiac rehabilitation program, rated from 0 to 10, being 10 the highest mark	6 months
Patient adherence	Patient adherence to cardiac rehabilitation sessions, rated from 0 to 100%, being 100% the highest mark	3 months
Change in basic functional independence assessed by the Barthel Index	Change in basic functional independence assessed by the Barthel Index (range 0-100, with higher scores indicating greater independence)	3 and 6 months
Change in maximal expiratory pressure (MEP)	Change in maximal expiratory pressure (MEP) measured in cmH₂O, with higher values indicating greater respiratory muscle strength	3 ad 6 months

Collaborators and Investigators

• Sponsor: Puerta de Hierro University Hospital
• Investigators: Principal Investigator: Margarita Calvo-LOpez, MD, Hospital Universitario Puerta de Hierro

Study record dates

Study Major Dates

• Study Start (Estimated): January 30, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: December 31, 2025
• First Submitted That Met QC Criteria: January 10, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 10, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Heart Failure; Cardiac rehabilitation; Functional capacity; Cardiopulmonary stress test
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: PI 195/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD collected throughout the trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No