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

Zhejiang University

Status: Enrolling

Conditions: Cardiac Surgery; Enhanced Recovery; Prehabilitation

Treatments: Behavioral: Prehabilitation; Behavioral: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT05503004

20220630

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Disability, severe psychiatric disease.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Behavioral: Prehabilitation

Standard care

Active Comparator group

Description:

Standard care before surgery

Treatment:

Behavioral: Standard care