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

Not Applicable

• Conditions: Enhanced Recovery; Prehabilitation; Cardiac Surgery
• Interventions: Behavioral: Prehabilitation; Behavioral: Standard care

• Registration Number: NCT05503004
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-08-01
• Study First Submitted QC: 2022-08-14
• Study First Posted: 2022-08-16
• Study Start: 2023-01-20
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-21
• Primary Completion: 2023-12-30
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• adult patients awaiting selective coronary artery bypass graft surgery (CABG) or valvular surgery

Exclusion Criteria

• Disability, severe psychiatric disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Prehabilitation	comprehensive prehabilitation program including supervised exercise., mindfulness and nutrition assessment.
Standard care	Standard care	Standard care before surgery

Primary Outcome Measures

Name	Time	Method
Preoperative physical function	up to 1 week	6-minute walk test distance in meters
Postoperative physical function	up to 2 weeks	6-minute walk test distance in meters

Secondary Outcome Measures

Name	Time	Method
ICU delirium	Up to 5 days	Assessed by nurses every shift using the Confusion Assessment Method of the Intensive Care Unit -7 (CAM-ICU-7). The CAM-ICU-7 score ranges from 0-7 with 7 being most severe.
Health related quality of life	up to 4 weeks	Using the The EuroQol 5 Dimension 5 Level (EQ-5D-5L). The EQ-5D-5L defines health conditions based on five dimensions (e.g. mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
Flow State	up to 2 weeks	Using the The Flow State Scale for Occupational Tasks (FSSOT). The total score ranges from 14 to 98 points. The high score is considered to indicate the strong flow state in performing a specific task.
Postoperative delirium	Up to 2 weeks	Assessed by nurses every shift using the 4AT Rapid clinical test for delirium. The 4AT is scored from 0-12. A score of 4 or more suggests delirium.
Gut microbiome diversity	up to 2 weeks	Stool collection and 16s RNA analysis
Short chain fatty acids (SCFAs)	up to 2 weeks	Stool collection and SCFAs quantitative analysis

Trial Locations

Locations (1)

Second Affiliated hospital of Zhejiang university School of medicine; 🇨🇳 Hangzhou, Zhejiang, China