NCT05503004

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

January 20, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

February 21, 2023

Status Verified

June 1, 2022

Enrollment Period

11 months

First QC Date

August 1, 2022

Last Update Submit

February 16, 2023

Conditions

Enhanced RecoveryPrehabilitationCardiac Surgery

Outcome Measures

Primary Outcomes (2)

  • Preoperative physical function

    6-minute walk test distance in meters

    up to 1 week

  • Postoperative physical function

    6-minute walk test distance in meters

    up to 2 weeks

Secondary Outcomes (6)

  • ICU delirium

    Up to 5 days

  • Health related quality of life

    up to 4 weeks

  • Flow State

    up to 2 weeks

  • Postoperative delirium

    Up to 2 weeks

  • Gut microbiome diversity

    up to 2 weeks

  • +1 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

comprehensive prehabilitation program including supervised exercise., mindfulness and nutrition assessment.

Behavioral: Prehabilitation

Standard care

ACTIVE COMPARATOR

Standard care before surgery

Behavioral: Standard care

Interventions

PrehabilitationBEHAVIORAL

10 min exercise, 5 min respiratory mindfulness, and preoperative nutrition assessment.

Intervention group
Standard careBEHAVIORAL

Standard care before surgery

Standard care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Disability, severe psychiatric disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated hospital of Zhejiang university School of medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37456818DERIVED

MeSH Terms

Interventions

Preoperative ExerciseStandard of Care

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and ServicesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Wen Gao, PhD

    Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen Gao, PhD

CONTACT

0086-18989879710wgao@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 16, 2022

Study Start

January 20, 2023

Primary Completion

December 30, 2023

Study Completion

June 1, 2024

Last Updated

February 21, 2023

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)