NCT07155421

Brief Summary

Acute decompensated heart failure (ADHF) is a severe condition characterized by rapid deterioration of cardiac function, leading to impaired oxygen delivery and multi-organ dysfunction. ADHF often results in reduced physical and respiratory capacity, greater dependence on oxygen support, difficulty performing daily activities, and prolonged hospital stays. In recent years, early exercise-based cardiopulmonary rehabilitation (CPR) has been introduced as part of heart failure management. Evidence suggests that early CPR improves overall health and cardiac function in heart failure patients. However, data regarding its effects in ADHF remain limited. While some studies indicate that early CPR enhances physical function, its impact on respiratory parameters and clinical outcomes is less well established. Cardiopulmonary rehabilitation is a multidisciplinary program designed to promote physical, psychological, and social recovery in patients with cardiovascular and pulmonary diseases. It includes exercise training, education, psychosocial support, and behavioral strategies. Early CPR specifically aims to improve cardiovascular and respiratory functions in heart failure patients. Initiating CPR in the early phase of ADHF may accelerate recovery, strengthen cardiopulmonary function, shorten hospitalization, and improve quality of life. This study aims to evaluate the effects of early CPR on functional capacity, hemodynamic parameters, and respiratory parameters in patients with ADHF.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 4, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

November 10, 2025

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 4, 2025

Status Verified

August 1, 2025

Enrollment Period

21 days

First QC Date

August 25, 2025

Last Update Submit

November 27, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Functional capacity

    It will be evaluated using 6-min walk test according to the guideline of American Thoracic Society

    At baseline and at hospital discharge, up to 14 days after admission

  • Physical performance

    It will evaluated using Short Physical Performance Battery.

    At baseline and at hospital discharge, up to 14 days after admission

Secondary Outcomes (5)

  • Maximum inspiratory and expiratory capacity

    At baseline and at hospital discharge, up to 14 days after admission

  • Hemodynamic responses to exercise

    At baseline and at hospital discharge, up to 14 days after admission

  • Hemodynamic responses to exercise

    At baseline and at hospital discharge, up to 14 days after admission

  • Hemodynamic responses to exercise

    At baseline and at hospital discharge, up to 14 days after admission

  • Subjective symptom responses to exercise

    At baseline and at hospital discharge, up to 14 days after admission

Study Arms (2)

Early cardiopulmonary rehabilitation group

EXPERIMENTAL

Exercise-based cardiopulmonary rehabilitation will be applied to this group during the hospital stay every day for 3 times a day.

Other: Early Cardiopulmonary RehabilitationOther: Routine in-hospital care

Control Group

OTHER

Routine in-hospital care will be applied to this group.

Other: Routine in-hospital care

Interventions

An individualized CPR program including positioning, deep breathing exercises (diaphragmatic and segmental breathing exercises), pursed-lip breathing exercises, breathing exercises using incentive spirometry, and progressive mobilization exercises (in-bed range of motion exercises, sitting, standing, and walking exercises)

Early cardiopulmonary rehabilitation group

Routine in-hospital care for acute decompansated heart failure

Control GroupEarly cardiopulmonary rehabilitation group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients hospitalized with a diagnosis of acute decompensated heart failure
  • Being clinically stable

You may not qualify if:

  • Having diagnosed pulmonary, neurological, renal, liver, gastrointestinal, orthopedic or oncological pathologies
  • Having cardiomyopathy or congestive pericarditis
  • Recent heart surgery in the past 6 months
  • New or suspected thromboembolic event
  • Presence of open wounds, ulcerations or major dermatological diseases in the lower extremities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University- Cerrahpasa, Cardiology Institute

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Kiymet Muammer, PT, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 4, 2025

Study Start

November 10, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

December 4, 2025

Record last verified: 2025-08

Locations