ExCR's Effects and Safety in Vulnerable ADHF Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-17

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Decompensated Heart Failure (ADHF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental group

Exercise rehabilitation

Group Type EXPERIMENTAL

Exercise rehabilitation

Intervention Type BEHAVIORAL

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.

Control group

Conventional rehabilitation

Group Type SHAM_COMPARATOR

Conventional rehabilitation

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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YE Jing

Chief Nurse of the Cardiovascular Intensive Care Unit

Responsibility Role SPONSOR_INVESTIGATOR