Ischaemic Heart DiseaseSheppHeartNCT01941355
Trial of Rehabilitation in Phase 1 After Coronary Artery Bypass Grafting
A study testing Exercise training component and Psycho-educative component in people with Ischaemic Heart Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischaemic Heart Disease
- What is being tested?
- Exercise training component and Psycho-educative component
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2013to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients at intermediate or high risk according to their cardiovascular status
- Patients with illness limiting the ability to exercise.
- Patients without permanent residence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Conditions
- Ischaemic Heart Disease
- Being tested
- Exercise training component, Psycho-educative component
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise training componentBehavioural
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.
Psycho-educative componentBehavioural
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 group | Role | What they receive |
|---|---|---|
| Exercise training, psycho-educative | Experimental | Not described Receives: Behavioral: Exercise training component; Behavioral: Psycho-educative component |
| Psycho-educative component | Experimental | Not described Receives: Behavioral: Psycho-educative component |
| Exercise training component | Experimental | Not described Receives: Behavioral: Exercise training component |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak oxygen uptake (VO2) between groups
Measured: At hospital discharge and 4 weeks following surgery
Change in self-reported health measured by SF-36 between groups
Measured: At hospital discharge and 4 weeks following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischaemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selina Kikkenborg Berg, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Selina K Berg, PhD, Post doc, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941355
- Sponsor's protocol ID
- SheppHeartCABG
- Acronym
- SheppHeart
- Status last verified
- Nov 2015
- First submitted
- 6 Sep 2013
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SheppHeartCABG Shaping Outcomes by Exercise Training and Psycho-education in Phase 1 for Coronary Artery Bypass Grafting Patients
- ClinicalTrials.gov ID
- NCT01941355
- Acronym / sponsor ID
- SheppHeart / SheppHeartCABG
- Conditions
- Ischaemic Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 13 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exercise training, psycho-educative | Experimental | Behavioral: Exercise training component, Behavioral: Psycho-educative component |
| Psycho-educative component | Experimental | Behavioral: Psycho-educative component |
| Exercise training component | Experimental | Behavioral: Exercise training component |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients at intermediate or high risk according to their cardiovascular status
- Patients with illness limiting the ability to exercise.
- Patients without permanent residence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise training componentThe 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. | Behavioural | Exercise training component, Exercise training, psycho-educative |
| Psycho-educative componentThe 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. | Behavioural | Exercise training, psycho-educative, Psycho-educative component |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selina K Berg, PhD, Post doc principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training component and Psycho-educative component in people with Ischaemic Heart Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak oxygen uptake (VO2) between groups (time frame: At hospital discharge and 4 weeks following surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2015.