ExCR's Effects and Safety in Vulnerable ADHF Patients

January 26, 2025 updated by: YE Jing

Effectiveness and Safety of Exercise-based Cardiac Rehabilitation (ExCR) During the Vulnerable Period in Patients with Acute Decompensated Heart Failure (ADHF): a Randomized Controlled Trial

Exercise-based cardiac rehabilitation has become a key component of the comprehensive care system for patients with stable heart failure (HF). However, due to hemodynamic instability and functional decline in early ADHF, most HF rehab studies exclude current/recent ADHF exacerbations. Currently, ADHF management strategies lack robust evidence, and the timing, duration, and frequency of exercise interventions need further validation globally.

This study aims to address the following issues:

Develop an exercise management program for ADHF patients, verify its feasibility, and determine the safety and applicability of early exercise rehabilitation; Evaluate the improvement of participants in terms of physical function, cardiac function, and quality of life.

The research team will compare the formulated exercise rehabilitation program with conventional rehabilitation guidance to verify its feasibility and effectiveness.

Participants will:

Physicians and rehabilitation therapists will comprehensively assess the participants' conditions to determine the start time of rehabilitation training. Based on the patients' cardiac function, muscle strength, and heart failure-related clinical indicators, rehabilitation training is divided into two stages (the first stage is early in-hospital training, and the second stage is self-directed training after discharge). Exercise types mainly include respiratory training, bed activities, rehabilitation pedaling, and resistance training. Rehabilitation therapists and nurses will monitor participants' vital signs during the exercise process and choose the appropriate exercise intensity based on the participants' level of fatigue.

The exercise rehabilitation program will be evaluated and adjusted every two weeks for a total period of 12 weeks.

At the time of enrollment, discharge, two weeks after discharge, and four weeks after discharge, participants will need to complete questionnaires, including demographic and disease condition surveys, grip strength tests, Activities of Daily Living (ADL) scales, Short Physical Performance Battery (SPPB) scales, Minnesota Living with Heart Failure Questionnaire (MLHFQ) scales, and 6-minute walk tests, etc.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100032
        • Peaking University First Hospital
        • Contact:
          • Yuling Wang
        • Contact:
          • Lei Yang
        • Contact:
        • Contact:
        • Contact:
          • Yimeng Jiang, Ph.D.
        • Contact:
          • Lihua Zhao, MSN.
        • Contact:
          • Wenhui Ding, Prof.
        • Contact:
          • Xiaoning Han, Ph.D.
        • Contact:
          • Baiyu Zhang
        • Contact:
          • Zhuo Zhao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Hospitalized for ADHF for over 24 hours.
  2. Age 18-80 years.
  3. At least one acute heart failure symptom: dyspnea at rest or exertion, fatigue, orthopnea, or paroxysmal nocturnal dyspnea.
  4. At least two heart failure signs: confirmed pulmonary congestion or edema on exam or chest X-ray, jugular venous distension, peripheral edema, rapid weight gain (>2 kg in 3 days), or elevated BNP (≥100 ng/L) and NT-proBNP (≥300 ng/L).
  5. Change in heart failure treatment plan with initiation or increased dosage of: diuretics, vasodilators, positive inotropic agents (e.g., digoxin), or other neurohormonal modulators (ACEI/ARB/ARNI, β-blocker, MRA).

Exclusion Criteria:

  1. Indications for urgent cardiovascular surgery (e.g., heart transplantation, left ventricular assist device).
  2. Cardiogenic shock.
  3. Recent deep vein thrombosis.
  4. Severe cardiovascular diseases (e.g., severe aortic stenosis, mitral regurgitation).
  5. GFR <30 ml/min or need for dialysis during the study.
  6. Severe COPD (FEV1/FVC <0.7 post-bronchodilator, with severe defined as 30% ≤ FEV1 <50% predicted, and very severe as FEV1 <30% predicted).
  7. Severe frailty (Clinical Frailty Scale CFS ≥7).
  8. Mental, psychological, cognitive disorders, or substance dependence.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Exercise rehabilitation
Behavioral: Exercise rehabilitation
The experimental group's protocol consists of two stages: in-hospital Phase I and post-discharge self-training. For Phase I, cardiac and rehab specialists assess NYHA classification, muscle strength, and mobility to create an exercise plan, supervised by therapists and nurses. Phase II involves twice-weekly outpatient rehab for 24 sessions and weekly remote guidance with WeChat and wristbands to track vitals, totaling 12 remote sessions. Exercise prescriptions are customized based on 6MWTD outcomes, with ongoing support from rehab staff and nurses.
Sham Comparator: Control group
Conventional rehabilitation
Behavioral: Conventional rehabilitation

Health Education: Nurses provide manuals on heart failure causes, treatment, diet, exercise (detailing frequency, intensity, duration, types, and safety), and self-monitoring to control group patients.

Outpatient Follow-up: Post-discharge, heart failure patients have follow-ups at 2 weeks, 1 month, 2 months, and 3 months. A multidisciplinary team of doctors, pharmacists, and nurses handles these, with doctors for assessment, pharmacists for medication education, and nurses for self-care assessment and education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the 6-minute walking test distance
Time Frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Assess the changes in participants' 6MWT distance at baseline and 1, 2, and 3 months post-discharge.
From enrollment to the end of the 12-week exercise rehabilitation intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left Ventricular Ejection Fraction （LVEF%）
Time Frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Assess the changes in participants' LVEF% at baseline and 1, 2, and 3 months post-discharge.
From enrollment to the end of the 12-week exercise rehabilitation intervention.
Brain Natriuretic Peptide（BNP）
Time Frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Assess the changes in participants' BNP at baseline and 1, 2, and 3 months post-discharge.
From enrollment to the end of the 12-week exercise rehabilitation intervention.
NYHA class
Time Frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Assess the changes in participants' NYHA class at baseline and 1, 2, and 3 months post-discharge.
From enrollment to the end of the 12-week exercise rehabilitation intervention.
Grip strength
Time Frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Assess grip strength using a dynamometer（CAMRY brand electronic hand dynamometer）; participants squeeze twice with their dominant hand and record the average.
From enrollment to the end of the 12-week exercise rehabilitation intervention.
Length of hospitalization
Time Frame: From hospitalization to discharge, an average of 12 weeks.
Length of hospitalization will be compared between intervention and control groups at discharge.
From hospitalization to discharge, an average of 12 weeks.
Short Physical Performance Battery（SPPB）
Time Frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
SPPB : Assesses physical performance with three tests: balance, 4-meter gait speed, and repeated chair stands. Each test scores 0-4; total score 0-12. Scores: 0-6 (poor), 7-9 (moderate), 10-12 (good).The SPPB scale will assess participants' physical performance at enrollment and 1, 2, and 3 months post-discharge.
From enrollment to the end of the 12-week exercise rehabilitation intervention.
Activities of Daily Living（ADL）
Time Frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Barthel Index: 10 items (feeding, bathing, grooming, dressing, bowel control, bladder control, toilet use, transfers, walking, stairs). Each item scored 0, 5, 10, 15; total 0-100. ≤40: severe dependence; 41-60: moderate; 61-99: mild; 100: independent. Higher scores indicate greater self-care ability.The Barthel Index will be used to assess ADL changes in participants at baseline and 1, 2, and 3 months post-discharge.
From enrollment to the end of the 12-week exercise rehabilitation intervention.
Quality of life using MLHFQ scale
Time Frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
MLHFQ scale: 21-item questionnaire assessing heart failure's impact on quality of life over the past month. Three domains: physical (8 items), emotional (5 items), and other (8 items). Each item scored 0-5 (0=none, 1=rarely, 2=occasionally, 3=sometimes, 4=often, 5=always). Total score: 0-105. Higher scores indicate worse quality of life; lower scores indicate better quality of life.The Minnesota Living with Heart Failure Questionnaire will be used to assess QoL changes in participants at baseline and 1, 2, and 3 months post-discharge.
From enrollment to the end of the 12-week exercise rehabilitation intervention.
Degree of frailty.
Time Frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Clinical Frailty Scale: 1-9 scale (very fit, well, managing well, vulnerable, mildly frail, moderately frail, severely frail, very severely frail, terminally ill). Score ≥5 indicates frailty.The Clinical Frailty Scale will be used to assess frailty changes in participants at baseline and at 1, 2, and 3 months post-discharge.
From enrollment to the end of the 12-week exercise rehabilitation intervention.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-month all-cause readmission rate
Time Frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
The 3-month all-cause readmission rate of study participants post-discharge.Assessment at 3 months post-discharge.
From enrollment to the end of the 12-week exercise rehabilitation intervention.
3-month all-cause mortality rate
Time Frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
The 3-month all-cause mortality rate of study participants post-discharge.Assessment at 3 months post-discharge.
From enrollment to the end of the 12-week exercise rehabilitation intervention.
Adverse events
Time Frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Adverse events will be monitored and recorded throughout the study. Data will be collected on falls, injuries, musculoskeletal issues, major cardiovascular events, and any other events potentially related to study protocol implementation.
From enrollment to the end of the 12-week exercise rehabilitation intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

YE Jing

Investigators

  • Study Chair: Jing Ye, MSN., Peaking University First Hospital
  • Study Director: Yimeng Jiang, Ph.D., Peaking University First Hospital
  • Principal Investigator: Lihua Zhao, MSN., Peaking University First Hospital
  • Principal Investigator: Wenhui Ding, Prof., Peaking University First Hospital
  • Principal Investigator: Xiaoning Han, Ph.D., Peaking University First Hospital
  • Principal Investigator: Lei Yang, Peaking University First Hospital
  • Principal Investigator: Yuling Wang, Peaking University First Hospital
  • Principal Investigator: Baiyu Zhang, Peaking University First Hospital
  • Principal Investigator: Zhuo Zhao, Peaking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 17, 2025

Primary Completion (Estimated)

February 17, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

January 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 26, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Peaking UFH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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