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Trial of Rehabilitation in Phase 1 After Coronary Artery Bypass Grafting (SheppHeart)

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Rigshospitalet

Status

Completed

Conditions

Ischaemic Heart Disease

Treatments

Behavioral: Exercise training component
Behavioral: Psycho-educative component

Study type

Interventional

Funder types

Other

Identifiers

NCT01941355
SheppHeartCABG

Details and patient eligibility

About

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.

Full 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)

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

60 participants in 4 patient groups

Exercise training, psycho-educative
Experimental group
Treatment:
Behavioral: Exercise training component
Behavioral: Psycho-educative component
Psycho-educative component
Experimental group
Treatment:
Behavioral: Psycho-educative component
Exercise training component
Experimental group
Treatment:
Behavioral: Exercise training component
Usual care
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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