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

The Second Affilliated Hospital of Zhejiang University, School of Medicine

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgery; Prehabilitation; Enhanced Recovery
• Intervention / Treatment: Behavioral: Prehabilitation; Behavioral: Standard care

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wen Gao, PhD; Phone Number: 0086-18989879710; Email: wgao@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Second Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Wen Gao, PhD; Phone Number: 0571-87783887; Email: wgao@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Disability, severe psychiatric disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; comprehensive prehabilitation program including supervised exercise., mindfulness and nutrition assessment.	Behavioral: Prehabilitation; 10 min exercise, 5 min respiratory mindfulness, and preoperative nutrition assessment.
Active Comparator: Standard care; Standard care before surgery	Behavioral: Standard care; Standard care before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative physical function	6-minute walk test distance in meters	up to 1 week
Postoperative physical function	6-minute walk test distance in meters	up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU delirium	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.	Up to 5 days
Health related quality of life	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).	up to 4 weeks
Flow State	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.	up to 2 weeks
Postoperative delirium	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.	Up to 2 weeks
Gut microbiome diversity	Stool collection and 16s RNA analysis	up to 2 weeks
Short chain fatty acids (SCFAs)	Stool collection and SCFAs quantitative analysis	up to 2 weeks

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Wen Gao, PhD, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2023
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 14, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 20220630

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No