Cardiac Surgery, Enhanced Recovery, Prehabilitation
Conditions
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.
Interventions
BEHAVIORALPrehabilitation
10 min exercise, 5 min respiratory mindfulness, and preoperative nutrition assessment.
BEHAVIORALStandard care
Standard care before surgery
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients awaiting selective coronary artery bypass graft surgery (CABG) or valvular surgery
Exclusion criteria
* Disability, severe psychiatric disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative physical function | up to 1 week | 6-minute walk test distance in meters |
| Postoperative physical function | up to 2 weeks | 6-minute walk test distance in meters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Flow State | 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 | 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. |
| ICU delirium | 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. |
| Short chain fatty acids (SCFAs) | up to 2 weeks | Stool collection and SCFAs quantitative analysis |
| Gut microbiome diversity | up to 2 weeks | Stool collection and 16s RNA analysis |
| Health related quality of life | 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). |
Countries
China
Contacts
Primary ContactWen Gao, PhD
Outcome results
None listed