Physical Rehabilitation for Older Patients Hospitalized for Heart Failure.
Dalane W Kitzman, David J Whellan, Pamela Duncan...
https://pubmed.ncbi.nlm.nih.gov/33999544Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06161987
Efficacy and Safety of Early Comprehensive Rehabilitation in Patients With ADHF, A Multicenter, Randomized, Controlled Trial.
Led by Guangdong Provincial People's Hospital · Updated on 2025-08-17
140
Participants Needed
1
Research Sites
25 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying patients with Acute Decompensated Heart Failure (ADHF) to evaluate the effects of early comprehensive rehabilitation, including exercise and inspiratory muscle training, on their quality of life. This multi-center, randomized controlled trial will compare these rehabilitation efforts to usual care, aiming to understand their impact on patient well-being and health outcomes over a six-week period. Participants will be randomly assigned to one of two groups: an intervention group receiving a structured rehabilitation program with 18 sessions combining endurance, resistance, balance, mobility, and inspiratory muscle exercises conducted three times weekly over six weeks, beginning during hospital stay and continuing as outpatient care; or a control group receiving usual care with bi-weekly contact from study staff. The study will also track hospital readmission and mortality rates up to six months after discharge. Throughout the study, participants will undergo baseline and week 6 assessments measuring quality of life using the Kansas City Cardiomyopathy Questionnaire and maximal inspiratory pressure as a percentage of predicted value. Additional evaluations include physical performance, frailty, pulmonary function, and monitoring of major adverse cardiovascular events. Follow-up visits will assess rehospitalization rates six months after discharge, with researchers closely monitoring participant progress and safety during the trial.
CONDITIONS
Brief Title
EACH-ADHF: Early Comprehensive Rehabilitation in Patients With ADHF
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- At least one symptom of heart failure upon admission such as difficulty breathing at rest or with exertion, orthopnea, paroxysmal nocturnal dyspnea, or exertional fatigue
- At least two signs of heart failure, including distended jugular veins, enlarged heart silhouette, apex beat displacement, third heart sound, increased venous pressure, pulmonary edema or congestion, peripheral edema, or elevated B-type natriuretic peptide
- Able to perform basic daily living activities independently before admission
- Able to complete baseline assessments and start the study treatment
- Able to walk 4 meters at enrollment, with assistive devices allowed
- Willing to participate, provide written informed consent, and cooperate with follow-up
You will not qualify if you...
- Acute heart failure caused by acute myocardial infarction
- Severe aortic valve stenosis
- Unstable heart rhythm causing hemodynamic instability
- Severe heart failure with high-degree atrioventricular block or inadequate heart rate response during exercise
- Isolated pulmonary hypertension
- Poorly controlled symptomatic orthostatic hypotension
- Hypertrophic obstructive cardiomyopathy
- Stage 5 chronic kidney failure or dialysis
- Liver enzyme levels (ALT or AST) 5 times above normal
- Awaiting heart transplant or ventricular assist device within six months, or post-heart transplant
- Chronic lung disease except COPD, prior lung surgery, or lung function-affecting diseases like scoliosis
- Late-stage illnesses other than heart failure
- Severe mental disorders, cognitive impairment, substance abuse, or addiction
- Severe language, psychological, or physical disabilities preventing participation
- Pregnant or lactating women or those unwilling/unable to use contraception
- Participation in other interventional clinical trials
- Deemed unfit for the study by the researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 weeks
Participants receive either a 6-week comprehensive rehabilitation program with exercise and inspiratory muscle training or usual care with bi-weekly contact from study personnel.
3 visits per week for 6 weeks for the rehabilitation group; bi-weekly contact for the control group
Follow-up
Duration - Up to 6 months
Participants are followed up to assess hospital readmission and mortality rates up to 6 months after discharge.
Periodic assessments up to 6 months after discharge
Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
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Research Team
H
Huan Ma, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Addition of Supervised Exercise Training to a Post-Hospital Disease Management Program for Patients Recently Hospitalized With Acute Heart Failure: The EJECTION-HF Randomized Phase 4 Trial.
Alison M Mudge, Charles P Denaro, Adam C Scott...
https://pubmed.ncbi.nlm.nih.gov/29413370Rehabilitation Therapy in Older Acute Heart Failure Patients (REHAB-HF) trial: Design and rationale.
Gordon R Reeves, David J Whellan, Pamela Duncan...
https://pubmed.ncbi.nlm.nih.gov/28267466Combined aerobic/resistance/inspiratory muscle training as the 'optimum' exercise programme for patients with chronic heart failure: ARISTOS-HF randomized clinical trial.
Ioannis D Laoutaris, Ewa Piotrowicz, Manolis S Kallistratos...
https://pubmed.ncbi.nlm.nih.gov/33624071The Efficacy and Safety of Phase I Cardiac Rehabilitation in Patients Hospitalized in Cardiac Intensive Care Unit With Acute Decompensated Heart Failure: A Study Protocol for a Randomized, Controlled, Clinical Trial.
Linjing Wu, Jiahua Li, Linjian Chen...
https://pubmed.ncbi.nlm.nih.gov/35350537Measuring frailty in heart failure: a community perspective.
Sheila M McNallan, Alanna M Chamberlain, Yariv Gerber...
https://pubmed.ncbi.nlm.nih.gov/24093859Inspiratory muscle training improves blood flow to resting and exercising limbs in patients with chronic heart failure.
Gaspar R Chiappa, Bruno T Roseguini, Paulo J C Vieira...
https://pubmed.ncbi.nlm.nih.gov/184361182022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.
Paul A Heidenreich, Biykem Bozkurt, David Aguilar...
https://pubmed.ncbi.nlm.nih.gov/35363499Validity, reliability, and responsiveness of the Kansas City Cardiomyopathy Questionnaire in anemic heart failure patients.
John A Spertus, Philip G Jones, John Kim...
https://pubmed.ncbi.nlm.nih.gov/18165909Early rehabilitation in older patients hospitalized with acute decompensated heart failure: A retrospective cohort study.
Shiho Takada, Takashiro Kondo, Masatoshi Yasunaga...
https://pubmed.ncbi.nlm.nih.gov/32956621