NCT07350941

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
20mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Jan 2026Jan 2028

First Submitted

Initial submission to the registry

December 31, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

December 31, 2025

Last Update Submit

January 10, 2026

Conditions

Heart Failure

Keywords

Heart FailureCardiac rehabilitationCardiopulmonary stress testFunctional capacity

Outcome Measures

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).

    3 months

Secondary Outcomes (14)

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

    3 months

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

    3 and 6 months

  • 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

    3 and 6 months

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

    3 and 6 months

  • +9 more secondary outcomes

Study Arms (2)

Cardiac rehabilitation group (treatment group)

EXPERIMENTAL

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

No intervention group

NO INTERVENTION

General exercise and educational recommendations

Interventions

Cardiac rehabilitation programOTHER

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.

Cardiac rehabilitation group (treatment group)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Margarita Calvo-LOpez, MD

    Hospital Universitario Puerta de Hierro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Margarita Calvo-Lopez, MD

CONTACT

+34637090285margarita.calvo@salud.madrid.org

Juan Carlos Lopez Azor, MD, PhD

CONTACT

+34628026462lopez.gcia.juan.carlos@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 31, 2025

First Posted

January 20, 2026

Study Start

January 30, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

All IPD collected throughout the trial

Locations

ES(1)