NCT05503004

Prehabilitation in Adult Patients Following Selective Cardiac Surgery: A Randomized Controlled Trial

The Second Affilliated Hospital of Zhejiang University, School of Medicine

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Aim: To determine the impact of an evidence-based comprehensive prehabilitation (EBCPrehab) program on pre- and postoperative capacity, functional capacity and health related quality of life (HRQoL) in patients awaiting elective coronary artery bypass graft surgery (CABG) or valvular surgery. Design: A single-center randomized controlled trail. SUBJECTS: Overall 160 preoperative elective cardiac surgery patients will be randomly assigned to an intervention or control group. Intervention: one-week EBCPrehab intervention, including supervised exercise, mindfulness and nutrition assessment. Control group: usual care. Main measures: At baseline, one day before surgery, three days after surgery and before discharge. The following measurements will be performed: six-minute walk test, ICU delirium, health related quality of life and flow state.

Detailed description

Enhanced recovery improves the quality of recovery following cardiac surgery, while the evidence of prehabilitation is still limited. We hypothesize that the implementation of a comprehensive prehabilitation program, including physical, mental and nutrition support could optimize the postoperative outcomes during hospital stay. A randomized controlled study of patients undergoing cardiac surgery with prehabilitation approach, is designed to compare patient outcomes. The samples will be collected from hospital registration and the invention will be conducted before surgery. During the 5-day prehabilitation intervention, patients will receive exercises, mindfulness and nutrition risk assessment. After surgery, the 6-minute walk test, delirium assessment, flow state and health related quality of life will be assessed to explore the effects of prehabilitation on patient outcomes.

Conditions

• Enhanced Recovery
• Prehabilitation
• Cardiac Surgery

Interventions

Type	Name	Description
BEHAVIORAL	Prehabilitation	10 min exercise, 5 min respiratory mindfulness, and preoperative nutrition assessment.
BEHAVIORAL	Standard care	Standard care before surgery

Timeline

• Start date: 2023-01-20
• Primary completion: 2023-12-30
• Completion: 2024-06-01
• First posted: 2022-08-16
• Last updated: 2023-02-21

Locations

1 site across 1 country: China