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
- Are there results?
- None posted in the registry
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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Second Affilliated Hospital of Zhejiang University, School of Medicine
- ClinicalTrials.gov ID
- NCT05503004
- Acronym / sponsor ID
- 20220630
- Conditions
- Enhanced Recovery, Prehabilitation, Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Prehabilitationcomprehensive prehabilitation program including supervised exercise., mindfulness and nutrition assessment. |
| Standard care | Active comparator | Behavioral: Standard careStandard care before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients awaiting selective coronary artery bypass graft surgery (CABG) or valvular surgery
Key exclusion criteria (1 listed)
- Disability, severe psychiatric disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitation10 min exercise, 5 min respiratory mindfulness, and preoperative nutrition assessment. | Behavioural | Intervention group |
| Standard careStandard care before surgery | Behavioural | Standard care |
Primary outcome
Preoperative physical function
Time frame: up to 1 week
6-minute walk test distance in meters
Postoperative physical function
Time frame: up to 2 weeks
6-minute walk test distance in meters
6 secondary outcomes
ICU delirium
Time frame: Up to 5 days
Health related quality of life
Time frame: up to 4 weeks
Flow State
Time frame: up to 2 weeks
Postoperative delirium
Time frame: Up to 2 weeks
Gut microbiome diversity
Time frame: up to 2 weeks
Short chain fatty acids (SCFAs)
Time frame: up to 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Derived from this study: PubMed 37456818Gao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen Gao, PhD principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen Gao, PhD (0086-18989879710, wgao@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative physical function (time frame: up to 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05503004, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.