Prehabilitation in Adult Patients Following Selective Cardiac Surgery: A Randomized Controlled Trial

NCT ID: NCT05503004

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-20

Study Completion Date

2024-06-01

Brief Summary

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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

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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

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Enhanced Recovery Prehabilitation Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Prehabilitation

Intervention Type BEHAVIORAL

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

Standard care

Standard care before surgery

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type BEHAVIORAL

Standard care before surgery

Interventions

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Prehabilitation

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

Intervention Type BEHAVIORAL

Standard care

Standard care before surgery

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Disability, severe psychiatric disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wen Gao, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Locations

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Second Affiliated hospital of Zhejiang university School of medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wen Gao, PhD

Role: CONTACT

0086-18989879710

Facility Contacts

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Wen Gao, PhD

Role: primary

0571-87783887

References

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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.

Reference Type DERIVED
PMID: 37456818 (View on PubMed)

Other Identifiers

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20220630

Identifier Type: -

Identifier Source: org_study_id

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