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NCT Number: NCT07350941

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac rehabilitation program

Other

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 outcomes

  1. Primary Endpoint: Change in Peak Oxygen Uptake

    Time frame: 3 months

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

Secondary outcomes

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

    Time frame: 3 months

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

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

    Time frame: 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)

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

    Time frame: 3 and 6 months

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

  4. Change in caregiver burden assessed by the Zarit scale

    Time frame: 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)

  5. Change in body composition parameters assessed by bioelectrical impedance analysis (BIA)

    Time frame: 3 and 6 months

    Change in body composition parameters expressed as percentages (%), assessed by bioelectrical impedance analysis (BIA)

  6. Number of participants experiencing all-cause mortality, heart failure decompensation, or heart failure-related hospitalization during follow-up

    Time frame: 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

  7. Change in Frailty status assessed by FRAIL scale

    Time frame: 3 and 6 months

    Change in FRAIL scale (range 0-5, higher scores indicate greater frailty)

  8. Change in emotional status assessed by the Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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

  9. Change in Nutritional Status assessed using the Mini Nutritional Assessment (MNA) score

    Time frame: 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)

  10. Change in Maximal Inspiratory Pressure (MIP)

    Time frame: 3 and 6 months

    Change in maximal inspiratory pressure (MIP) measured in cmH₂O, with higher values indicating greater respiratory muscle strength

  11. Patient satisfaction

    Time frame: 6 months

    Patient satisfaction with the cardiac rehabilitation program, rated from 0 to 10, being 10 the highest mark

  12. Patient adherence

    Time frame: 3 months

    Patient adherence to cardiac rehabilitation sessions, rated from 0 to 100%, being 100% the highest mark

  13. Change in basic functional independence assessed by the Barthel Index

    Time frame: 3 and 6 months

    Change in basic functional independence assessed by the Barthel Index (range 0-100, with higher scores indicating greater independence)

  14. Change in maximal expiratory pressure (MEP)

    Time frame: 3 ad 6 months

    Change in maximal expiratory pressure (MEP) measured in cmH₂O, with higher values indicating greater respiratory muscle strength

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Carlos Lopez Azor, MD, PhD

CONTACT

[email protected]

+34628026462

Margarita Calvo-Lopez, MD

CONTACT

[email protected]

+34637090285

Sponsors and collaborators

Lead sponsor

Puerta de Hierro University Hospital

Other

Registry information

Official study title

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

Acronym: RAP-IC

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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