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

Cardiac Surgery Clinical Trial

Official title:

The Second Affilliated Hospital of Zhejiang University, School of Medicine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05503004
• Other study ID #: 20220630
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cardiac Surgery
• Enhanced Recovery
• Prehabilitation

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