Trial of Rehabilitation in Phase 1 After Coronary Artery Bypass Grafting (SheppHeart)
Primary Purpose
Ischaemic Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Exercise training component
Psycho-educative component
Sponsored by
About this trial
This is an interventional supportive care trial for Ischaemic Heart Disease
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.
Sites / Locations
- Rigshospitalet
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Exercise training, psycho-educative
Psycho-educative component
Exercise training component
Usual care
Arm Description
Outcomes
Primary Outcome Measures
Change in peak oxygen uptake (VO2) between groups
Change in self-reported health measured by SF-36 between groups
Secondary Outcome Measures
Full Information
NCT ID
NCT01941355
First Posted
September 6, 2013
Last Updated
November 4, 2015
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT01941355
Brief Title
Trial of Rehabilitation in Phase 1 After Coronary Artery Bypass Grafting
Acronym
SheppHeart
Official Title
SheppHeartCABG Shaping Outcomes by Exercise Training and Psycho-education in Phase 1 for Coronary Artery Bypass Grafting Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischaemic Heart Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise training, psycho-educative
Arm Type
Experimental
Arm Title
Psycho-educative component
Arm Type
Experimental
Arm Title
Exercise training component
Arm Type
Experimental
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Exercise training component
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psycho-educative component
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in peak oxygen uptake (VO2) between groups
Time Frame
At hospital discharge and 4 weeks following surgery
Title
Change in self-reported health measured by SF-36 between groups
Time Frame
At hospital discharge and 4 weeks following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selina K Berg, PhD, Post doc
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Trial of Rehabilitation in Phase 1 After Coronary Artery Bypass Grafting
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