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

SheppHeartCABG Shaping Outcomes by Exercise Training and Psycho-education in Phase 1 for Coronary Artery Bypass Grafting Patients

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.

Study Overview

• Status: Completed
• Conditions: Ischaemic Heart Disease
• Intervention / Treatment: Behavioral: Exercise training component; Behavioral: Psycho-educative component

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
Experimental: Exercise training, psycho-educative	Behavioral: Exercise training component; The physical exercises consist of; deep breathing exercises and breathing exercises using incentive spirometry with expiratory positive pressure airway, cycling exercises during hospitalisation and an individualised exercise programme running from discharge to 4 weeks following surgery.; Behavioral: Psycho-educative component; The psycho-educative rehabilitation programme consists of four psycho-educative consultations with a specially trained nurse. The last consultation will take place 4 weeks following surgery.
Experimental: Psycho-educative component	Behavioral: Psycho-educative component; The psycho-educative rehabilitation programme consists of four psycho-educative consultations with a specially trained nurse. The last consultation will take place 4 weeks following surgery.
Experimental: Exercise training component	Behavioral: Exercise training component; The physical exercises consist of; deep breathing exercises and breathing exercises using incentive spirometry with expiratory positive pressure airway, cycling exercises during hospitalisation and an individualised exercise programme running from discharge to 4 weeks following surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Selina K Berg, PhD, Post doc, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: September 6, 2013
• First Submitted That Met QC Criteria: September 11, 2013
• First Posted (Estimate): September 13, 2013

Study Record Updates

• Last Update Posted (Estimate): November 5, 2015
• Last Update Submitted That Met QC Criteria: November 4, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: SheppHeartCABG