Enhanced RecoveryNCT05503004
Prehabilitation in Adult Patients Following Selective Cardiac Surgery: A Randomized Controlled Trial
A study testing Prehabilitation in people with Enhanced Recovery and Prehabilitation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enhanced Recovery, Prehabilitation, Cardiac Surgery
- What is being tested?
- Prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2023to 1 Jun 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients awaiting selective coronary artery bypass graft surgery (CABG) or valvular surgery
Who cannot join
- Disability, severe psychiatric disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated hospital of Zhejiang university School of medicine
Hangzhou, Zhejiang, 310009
Wen Gao, PhD, 0571-87783887, wgao@zju.edu.cn
About this study
Official title: The Second Affilliated Hospital of Zhejiang University, School of Medicine
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.
Read the 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.
- Conditions
- Enhanced Recovery, Prehabilitation, Cardiac Surgery
- Being tested
- Prehabilitation, Standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationBehavioural
10 min exercise, 5 min respiratory mindfulness, and preoperative nutrition assessment.
Standard careBehavioural
Standard care before surgery
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | comprehensive prehabilitation program including supervised exercise., mindfulness and nutrition assessment. Receives: Behavioral: Prehabilitation |
| Standard care | Active comparator | Standard care before surgery Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative physical function
6-minute walk test distance in meters
Measured: up to 1 week
Postoperative physical function
6-minute walk test distance in meters
Measured: up to 2 weeks
Secondary outcomes (6)
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.
Measured: Up to 5 days
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).
Measured: up to 4 weeks
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.
Measured: up to 2 weeks
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.
Measured: Up to 2 weeks
Gut microbiome diversity
Stool collection and 16s RNA analysis
Measured: up to 2 weeks
Short chain fatty acids (SCFAs)
Stool collection and SCFAs quantitative analysis
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start20 Jan 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enhanced RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen Gao, PhD, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503004
- Sponsor's protocol ID
- 20220630
- Status last verified
- Jun 2022
- First submitted
- 1 Aug 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gao W, Li H, Chen Y, Zhang Y, Zhang M, Jin J. Effectiveness of a short-term multimodal prehabilitation program in adult patients awaiting selective cardiac surgery: study protocol for an open-label, pilot, randomized controlled trial. Front Cardiovasc Med. 2023 Jun 30;10:1201737. doi: 10.3389/fcvm.2023.1201737. eCollection 2023.
PubMed 37456818