Clinical trial NCT01941355: Trial of Rehabilitation in Phase 1 After Coronary Artery Bypass Grafting
Official title: SheppHeartCABG Shaping Outcomes by Exercise Training and Psycho-education in Phase 1 for Coronary Artery Bypass Grafting Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischaemic Heart Disease
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Change in peak oxygen uptake (VO2) between groups
timeFrame: At hospital discharge and 4 weeks following surgery
measure: Change in self-reported health measured by SF-36 between groups
timeFrame: At hospital discharge and 4 weeks following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Selina K Berg, PhD, Post doc
role: PRINCIPAL_INVESTIGATOR
References: