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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05503004
Other study ID # 20220630
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 20, 2023
Est. completion date June 1, 2024

Study information

Verified date June 2022
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Wen Gao, PhD
Phone 0086-18989879710
Email wgao@zju.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date June 1, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - adult patients awaiting selective coronary artery bypass graft surgery (CABG) or valvular surgery Exclusion Criteria: - Disability, severe psychiatric disease.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Second Affiliated hospital of Zhejiang university School of medicine Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Preoperative physical function 6-minute walk test distance in meters up to 1 week
Primary Postoperative physical function 6-minute walk test distance in meters up to 2 weeks
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Gut microbiome diversity Stool collection and 16s RNA analysis up to 2 weeks
Secondary Short chain fatty acids (SCFAs) Stool collection and SCFAs quantitative analysis up to 2 weeks
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