NCT06161987

EACH-ADHF: Early Comprehensive Rehabilitation in Patients With ADHF

Efficacy and Safety of Early Comprehensive Rehabilitation in Patients With ADHF, A Multicenter, Randomized, Controlled Trial.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

EACH-ADHF: Early Comprehensive Rehabilitation in patients with ADHF study is a multi-center, parallel-group, randomized controlled trial designed to evaluate the effects of the early comprehensive rehabilitation including exercise and inspiratory muscle training, over a period of 6 weeks, on the quality of life of patients with ADHF.

Detailed description

Guangdong Provincial People's Hospital will be the lead center, with an additional 8 hospitals designated as satellite centers for the study. To sum up, these centers will recruit a total of 140 consenting patients. Following informed consent and baseline testing, the participants will be randomized in a 1:1 fashion to receive a 6-week progressive, comprehensive exercise training and inspiratory muscle training or attention control. The intervention group will receive an 6-week exercise program consisting of endurance, resistance, balance, mobility, and inspiratory muscle training. The comprehensive rehabilitation will begin during the patient's stay and continue to the outpatient clinic. The control group will receive usual care with bi-weekly contact from study personnel. The primary outcomes of the study are improvements in the summary score of KCCQ and PImax%pred, while secondary endpoints include the impact on physical function, cardiac function, psychological status, and major adverse cardiovascular events (MACE). Additionally, the study will also explore the effects of comprehensive rehabilitation on hospital readmission and mortality rates, with follow-up assessments planned up to 6 months after discharge.

Conditions

• Acute Decompensated Heart Failure

Interventions

Type	Name	Description
BEHAVIORAL	Early comprehensive rehabilitation	Patients randomized to the rehabilitation intervention group will be offered comprehensive rehabilitation plan containing 18 sessions of a structured outpatient-based exercise program over 6 weeks (3 times per week).

Timeline

• Start date: 2023-12-01
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2023-12-08
• Last updated: 2025-08-17

Locations

1 site across 1 country: China