Clinical trial NCT05503004: Prehabilitation in Adult Patients Following Selective Cardiac Surgery: A Randomized Controlled Trial
Official title: The Second Affilliated Hospital of Zhejiang University, School of Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Enhanced Recovery
Prehabilitation
Cardiac Surgery
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Disability, severe psychiatric disease.

Primary outcomes:
measure: Preoperative physical function
timeFrame: up to 1 week
measure: Postoperative physical function
timeFrame: up to 2 weeks
Secondary outcomes:
measure: ICU delirium
timeFrame: Up to 5 days
measure: Health related quality of life
timeFrame: up to 4 weeks
measure: Flow State
timeFrame: up to 2 weeks
measure: Postoperative delirium
timeFrame: Up to 2 weeks
measure: Gut microbiome diversity
timeFrame: up to 2 weeks
measure: Short chain fatty acids (SCFAs)
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated hospital of Zhejiang university School of medicine
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Wen Gao, PhD
role: PRINCIPAL_INVESTIGATOR
References: