Trial of Rehabilitation in Phase 1 After Coronary Artery Bypass Grafting

Not Applicable

Completed

• Conditions: Ischaemic Heart Disease
• Interventions: Behavioral: Psycho-educative component; Behavioral: Exercise training component

• Registration Number: NCT01941355
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

Patients undergoing coronary artery bypass graft surgery often experience a range of problems and symptoms related to the procedure and the underlying heart disease. These problems include anxiety and depressive symptoms, immobility issues, complications such as wound seeping, neck and shoulder pains, interrupted and insufficient sleep. Over the last 2 decades, cardiac rehabilitation has become recognized as a significant component in the continuum of care for persons with cardiovascular disease. Furthermore, cardiac rehabilitation has undergone a significant evolution moving from a focused exercise intervention to a comprehensive disease management program. In Guidelines for Coronary Artery Bypass Graft Surgery cardiac rehabilitation is described to include early ambulation during hospitalisation, and outpatient prescriptive exercise training beginning 6-8 weeks following surgery. Our hypothesis is that physical exercise with moderate intensity and a psycho-educative component as a part of cardiac rehabilitation can begin in early postoperatively during hospitalising. Results from studies on phase 1 rehabilitation in coronary artery bypass graft surgery patients are promising. However, no randomised trials have been conducted, and evidence is therefore lacking.

The objective of this pilot trial is to investigate the effect of a phase 1 comprehensive cardiac rehabilitation programme consisting of a psycho-educative component, an exercise-training component including pulmonary training, cycling, neck and shoulder exercises, these in combination plus treatment as usual and treatment as usual in patients who undergo coronary artery bypass grafting.

SheppHeartCABG is an investigator-initiated 2 x 2 factorial randomised clinical pilot trial with blinded outcome assessment. Recruitment from one site with 1:1:1:1 central randomisation to phase 1 rehabilitation; 1) exercise-training plus usual care, 2) psycho-educative plus usual care 3) exercise-training and psycho-educative plus usual, 4) usual care alone.

Detailed Description

The explorative outcome measures consist of two parts: physical capacity and mental and physical health. Physical capacity is measured by peak VO2 max and 6 minutes' walk test at discharge and 4 weeks following surgery. Perceived mental and physical health is measured by the Medical Outcome Study Short Form 36 (SF-36) at admission, discharge and 4 weeks following surgery. Furthermore questionnaires measuring anxiety and depression (Hospital Anxiety and Depression Scale), health-related quality of life (HeartQoL), fatigue (MFI-20) cognitive and emotional representation of illness (B-IPQ), physical activity (IPAQ), self-rated health (EQ-5D), sleep (PSQI) and pain (ÖMPSQ)

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-06
• Study First Submitted QC: 2013-09-11
• Study First Posted: 2013-09-13
• Primary Completion: 2013-11
• Study Completion: 2014-04
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-04
• Last Update Posted: 2015-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 18 years or older.
• Persons with ischaemic heart disease referred to elective coronary artery bypass graft surgery.
• Speaks and understands Danish.
• Provide written informed consent.

Exclusion Criteria

• Patients at intermediate or high risk according to their cardiovascular status
• Patients with illness limiting the ability to exercise.
• Patients without permanent residence.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Psycho-educative component	Psycho-educative component	-
Exercise training, psycho-educative	Psycho-educative component	-
Exercise training, psycho-educative	Exercise training component	-
Exercise training component	Exercise training component	-

Primary Outcome Measures

Name	Time	Method
Change in peak oxygen uptake (VO2) between groups	At hospital discharge and 4 weeks following surgery
Change in self-reported health measured by SF-36 between groups	At hospital discharge and 4 weeks following surgery

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark