Acute Decompensated Heart Failure (ADHF)
Conditions
Keywords
Acute Decompensated Heart Failure (ADHF)；Vulnerable Phase；Exercise Rehabilitation；RCT
Brief summary
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.
Interventions
BEHAVIORALExercise 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.
BEHAVIORALConventional 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.
Sponsors
YE Jing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the 6-minute walking test distance | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grip strength | 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. |
| Activities of Daily Living（ADL） | 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. |
| Quality of life using MLHFQ scale | 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. |
| Degree of frailty. | 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. |
| Left Ventricular Ejection Fraction （LVEF%） | 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. |
| Brain Natriuretic Peptide（BNP） | 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. |
| NYHA class | 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. |
| Length of hospitalization | From hospitalization to discharge, an average of 12 weeks. | Length of hospitalization will be compared between intervention and control groups at discharge. |
| Short Physical Performance Battery（SPPB） | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 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. |
| 3-month all-cause mortality rate | 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. |
| 3-month all-cause readmission rate | 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. |
Countries
China
Contacts
Primary ContactJing Ye, MSN.
Backup ContactLihua Zhao, MSN.
Outcome results
None listed