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

Overview

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.

Full Title of Study: “The Second Affilliated Hospital of Zhejiang University, School of Medicine”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2023

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.

Interventions

  • Behavioral: Prehabilitation
    • 10 min exercise, 5 min respiratory mindfulness, and preoperative nutrition assessment.
  • Behavioral: Standard care
    • Standard care before surgery

Arms, Groups and Cohorts

  • Experimental: Intervention group
    • comprehensive prehabilitation program including supervised exercise., mindfulness and nutrition assessment.
  • Active Comparator: Standard care
    • Standard care before surgery

Clinical Trial Outcome Measures

Primary Measures

  • Preoperative physical function
    • Time Frame: up to 1 week
    • 6-minute walk test
  • Postoperative physical function
    • Time Frame: up to 2 weeks
    • 6-minute walk test

Secondary Measures

  • ICU delirium
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

Inclusion Criteria

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

  • Disability, severe psychiatric disease.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Wen Gao, PhD, Principal Investigator, Zhejiang University
  • Overall Contact(s)
    • Wen Gao, PhD, 0086-18989879710, wgao@zju.edu.cn

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