NCT Number: NCT06795737
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100032, China
Baiyu Zhang
PRINCIPAL_INVESTIGATOR
Jing Ye, MSN.
CONTACT
Lei Yang
PRINCIPAL_INVESTIGATOR
Lihua Zhao, MSN.
CONTACT
Lihua Zhao, MSN.
PRINCIPAL_INVESTIGATOR
Wenhui Ding, Prof.
PRINCIPAL_INVESTIGATOR
Xiaoning Han, Ph.D.
PRINCIPAL_INVESTIGATOR
Yimeng Jiang, Ph.D.
PRINCIPAL_INVESTIGATOR
Yuling Wang
PRINCIPAL_INVESTIGATOR
Zhuo Zhao
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
Time frame: From hospitalization to discharge, an average of 12 weeks.
Length of hospitalization will be compared between intervention and control groups at discharge.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Jing Ye, MSN.
CONTACT
Lihua Zhao, MSN.
CONTACT
YE Jing
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07377019
Acute Decompensated Heart Failure (ADHF), Cardio-Renal Syndrome
Svendborg, Denmark
View Trial DetailsNCT07262723
Acute Decompensated Heart Failure (ADHF)
Chittagong, Bangladesh
View Trial DetailsNCT06671067
Acute Decompensated Heart Failure (ADHF), Acute Myocardial Infarction
Kaifeng, Henan, China
View Trial DetailsNCT07038356
Acute Decompensated Heart Failure (ADHF)
Jena, Thuringia, Germany
View Trial Details