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

• ClinicalTrials.gov Identifier: NCT01941355
• Recruitment Status: Completed
• First Posted: September 13, 2013
• Last Update Posted: November 5, 2015
• Sponsor: Rigshospitalet, Denmark
• Information provided by (Responsible Party): Selina Kikkenborg Berg, Rigshospitalet, Denmark

Tracking Information

• First Submitted Date: September 6, 2013
• First Posted Date: September 13, 2013
• Last Update Posted Date: November 5, 2015
• Study Start Date: September 2013
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 11, 2013)

• Change in peak oxygen uptake (VO2) between groups [ Time Frame: At hospital discharge and 4 weeks following surgery ]
• Change in self-reported health measured by SF-36 between groups [ Time Frame: At hospital discharge and 4 weeks following surgery ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Ischaemic Heart Disease

Intervention

• 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.

Study Arms

• Experimental: Exercise training, psycho-educative
  Interventions:

  • Behavioral: Exercise training component
  • Behavioral: Psycho-educative component
• Experimental: Psycho-educative component
  Intervention: Behavioral: Psycho-educative component
• Experimental: Exercise training component
  Intervention: Behavioral: Exercise training component
• No Intervention: Usual care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 11, 2013): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 2014
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT01941355
• Other Study ID Numbers: SheppHeartCABG
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Selina Kikkenborg Berg, Rigshospitalet, Denmark
• Study Sponsor: Rigshospitalet, Denmark
• Collaborators: Not Provided

Investigators

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

• PRS Account: Rigshospitalet, Denmark
• Verification Date: November 2015