Early bedside personalized rehabilitation for elderly patients with acute decompensated heart failure
| ISRCTN | ISRCTN17793032 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17793032 |
| Sponsor | The Affiliated Hospital of Jiujiang University |
| Funder | Science and Technology Research Project of Jiangxi Provincial Department of Education (GJJ2401806) |
- Submission date
- 22/09/2026
- Registration date
- 23/09/2026
- Last edited
- 23/09/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Acute decompensated heart failure (ADHF) is a sudden worsening of heart failure symptoms and is a common cause of hospitalisation among older adults. Patients with ADHF often experience reduced physical function, muscle weakness, and difficulty returning to normal activities after hospitalisation. Although rehabilitation is beneficial for patients with stable heart failure, the feasibility and safety of starting personalised bedside rehabilitation during the acute phase of ADHF remain unclear.
This study aims to evaluate the feasibility and safety of early bedside personalised rehabilitation in elderly patients with ADHF. The study also aims to explore the potential effects of this rehabilitation strategy on functional capacity and congestion-related conditions before hospital discharge.
Who can participate?
Patients aged 65 years or older who are admitted to the cardiac intensive care unit due to ADHF with severe symptoms
What does the study involve?
Participants will be randomly allocated to either an early bedside personalised rehabilitation group or a usual care group. Participants in the rehabilitation group will receive an individualised bedside rehabilitation programme based on daily functional assessment. The programme includes early mobilisation training, respiratory rehabilitation, progressive sitting and standing exercises, resistance exercises, and walking training according to each participant’s clinical condition and functional capacity. Participants in the usual care group will receive standard medical treatment and routine nursing care according to clinical practice. The intervention will be provided during hospitalisation until discharge under the supervision of trained healthcare professionals.
What are the possible benefits and risks of participating?
Participants may benefit from receiving structured rehabilitation support that may help maintain or improve physical function during hospitalisation. However, individual benefits cannot be guaranteed.
Potential risks include temporary fatigue, shortness of breath, dizziness, changes in heart rate or blood pressure, or other discomfort related to physical activity. The rehabilitation programme will be adjusted according to each participant’s clinical condition, and exercise will be stopped if safety concerns occur.
Where is the study run from?
The Affiliated Hospital of Jiujiang University (China)
When is the study starting and how long is it expected to run for?
January 2024 to August 2025
Who is funding the study?
The Science and Technology Research Project of Jiangxi Provincial Department of Education (GJJ2401806) (China)
Who is the main contact?
Xiao-Yong Zhu, 870496665@qq.com
Contact information
Principal investigator, Public
Department of Cardiology, The Affiliated Hospital of Jiujiang University, Xunyang District
Jiujiang
332000
China
 ORCID ID |
0000-0003-1103-1227 |
|---|---|
| Phone | +86 (0)18879292198 |
| 870496665@qq.com |
Scientific
Department of Cardiology, East Campus, The Affiliated Hospital of Jiujiang University, Xunyang District
Jiujiang
332000
China
| ORCID ID |
0000-0003-1103-1227 |
|---|---|
| Phone | +86 (0)18879292198 |
| 870496665@qq.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Health services research, Treatment |
| Scientific title | Effects of early bedside personalized rehabilitation on functional capacity and congestion relief in acute decompensated heart failure patients prior to discharge: a pilot randomized controlled trial in elderly heart failure patients |
| Study objectives | The primary objective of this pilot randomized controlled trial was to evaluate the feasibility and safety of early bedside personalized rehabilitation in elderly patients with acute decompensated heart failure. The secondary objective was to explore the potential effects of this intervention on pre-discharge functional capacity and congestion status. |
| Ethics approval(s) |
Approved 20/12/2023, Medical Ethics Committee of the Affiliated Hospital of Jiujiang University (Jiujiang University Affiliated Hospital, Xunyang District, Jiujiang, 332000, China; +86 (0)7922180161; jjxysyjyk@163.com), ref: jjuhmer-b-2023-12003 |
| Health condition(s) or problem(s) studied | Acute decompensated heart failure in elderly patients requiring intensive care management |
| Intervention | Participants were randomly assigned in a 1:1 ratio using a random sequence generated by independent statisticians. Allocation was concealed using sequentially numbered opaque envelopes. Participants in the intervention group received an individualized bedside rehabilitation program based on daily functional assessment. The rehabilitation protocol included early mobilization training, respiratory rehabilitation, progressive sitting and standing exercises, and walking training according to patients' clinical condition and functional capacity. The control group received usual care, including standard medical treatment and routine nursing management according to clinical practice. The intervention was conducted during hospitalization until discharge under the supervision of trained healthcare professionals. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 01/08/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Upper age limit | 90 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Age ≥65 years 2. Hospitalized in the cardiac intensive care unit (CICU) due to acute decompensated heart failure (ADHF) with New York Heart Association (NYHA) functional class III–IV 3. Symptoms worsening, including dyspnea, fluid retention, or hypoperfusion, requiring mechanical ventilation or non-invasive ventilation 4. Clinically stabilized and suitable for early bedside rehabilitation |
| Key exclusion criteria | 1. Acute coronary syndrome within 2 days or chest pain within 8 hours 2. Malignant arrhythmias 3. Severe aortic stenosis 4. Aortic dissection 5. Acute myocarditis, acute pericarditis, or acute infective endocarditis 6. Recent embolism or cardiac/venous thrombosis 7. Long-term hemodialysis 8. Previous cognitive impairment 9. Inability to walk independently |
| Date of first enrolment | 09/01/2024 |
| Date of final enrolment | 31/01/2025 |
Locations
Countries of recruitment
- China
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
22/09/2026: Study's existence confirmed by the Medical Ethics Committee of the Affiliated Hospital of Jiujiang University.
