Patients Waiting for Elective Coronary Artery Bypass Graft SurgeryNCT01914094
Pre-habilitation Program for Elective Coronary Artery Bypass Graft Surgery Patients
A study testing Prehab in people with Patients Waiting for Elective Coronary Artery Bypass Graft Surgery, run by St. Boniface Hospital at 1 site in Canada.
Trial summary
Low levels of physical fitness increase the risk of death in patients with cardiovascular disease. Although cardiac rehabilitation programs improve the health of patients after heart surgery, most patients are not referred until after surgery. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Patients Waiting for Elective Coronary Artery Bypass Graft Surgery
- What is being tested?
- Prehab
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2011to Feb 2013
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- On elective waitlist for coronary artery bypass graft surgery with a minimum anticipated wait time of 4-6 weeks or more
- No history of unstable angina
- Canadian Cardiovascular Society score of less than 4
- No history of myocardial infarction within the past 7 days
- Ejection fraction greater than 30%
- No history of dementia or psychiatric problems
Show all 11Show fewer
- No self-reported dizziness or confusion
- Able to read, speak, and understand English
- Previously sedentary (reporting accumulating less than 45 minutes of moderate intensity physical activity per day on at least three days per week over the last three months)
- No previous participation in cardiac rehabilitation
- Lives in Winnipeg, Manitoba, Canada or has easy access to the Reh-Fit Centre (local medical fitness facility)
Who cannot join
- If patients cannot attend Prehab due to geographical limitations
- If patients cannot participate due to physical limitations
- Diagnosis of exercise-induced arrhythmia
Trial locations and contacts
1 site in 1 country.
About this study
Low levels of physical fitness increase the risk of death in patients with cardiovascular disease. Although cardiac rehabilitation programs improve the health of patients after heart surgery, most patients are not referred until after surgery. Therefore, the purpose of this study was to determine if an exercise "pre-habilitation" (i.e., Prehab) program before heart surgery would improve the health of patients before surgery and whether these improvements would be maintained after surgery.
The investigators hypothesized that Prehab would promote the health of patients before heart surgery, and these improvements would be maintained three months post-operatively, as compared to patients who received standard care.
Read the detailed description
This was a single-centre, parallel randomized controlled trial conducted in Canada to determine the feasibility and efficacy of an exercise and education "pre-habilitation" (i.e., Prehab) program before elective coronary artery bypass graft surgery (CABG). We recruited 17 patients who were scheduled to undergo elective CABG surgery from February 2011-May 2012. Enrolled patients were assessed at baseline, one week pre-operatively, and three months post-operatively.
- Being tested
- Prehab
- Keywords
- Preoperative care, Exercise therapy, Cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabBehavioural
Also called Pre-habilitation, Preoperative exercise therapy
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Received current standard care. |
| Prehab | Experimental | Received pre-operative exercise therapy plus education classes concerning management of their risk factors for coronary artery disease at a local medical fitness facility. Receives: Behavioral: Prehab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-minute walking distance
Assessed using the 6-minute walking test. Output is distance. Change from baseline 6-minute walking distance was assessed at each follow-up time point.
Measured: Baseline; 1 week pre-operatively; 3 months post-operatively
Secondary outcomes (6)
Change in 5-meter gait speed
Assessed using the 5-meter gait speed test. Output is seconds. Change from baseline 5-meter gait speed was assessed at each follow-up time point.
Measured: Baseline; 1 week pre-operatively; 3 months post-operatively
Change in objectively measured physical activity
Measured by accelerometry. Output is minutes of moderate-vigorous as well as total physical activity per week. Change from baseline physical activity was assessed at each follow-up time point.
Measured: Baseline; 1 week pre-operatively; 3 months post-operatively
Change in quality of life
Self-reported using the Short Form-36 questionnaire. Output is a summary score across eight dimensions: General health, Physical functioning, Role limitations due to physical health, Role limitations due to emotional problems, Energy/fatigue, Pain, Emotional well-being, and Social functioning. Change from baseline quality of life measures was assessed at each follow-up time point.
Measured: Baseline; 1 week pre-operatively; 3 months post-operatively
Change in depressive symptoms
Assessed using the Patient Health Questionnaire-9. Output was a numerical and categorical score. Change from baseline depressive symptoms was assessed at each follow-up time point.
Measured: Baseline; 1 week pre-operatively; 3 months post-operatively
Change in exercise self-efficacy
Assessed by the Cardiac Exercise Self-efficacy Index. Output was a numerical score. Change from baseline exercise self-efficacy was assessed at each follow-up time point.
Measured: Baseline; 1 week pre-operatively; 3 months post-operatively
Change in cardiac anxiety
Assessed by the Cardiac Anxiety Questionnaire. Outputs were numerical scores across four dimensions: Fear, Avoidance, Heart-Focused Attention, and Total Score. Change from baseline cardiac anxiety was assessed at each follow-up time point.
Measured: Baseline; 1 week pre-operatively; 3 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startFeb 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Waiting for Elective Coronary Artery Bypass Graft SurgeryStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Boniface Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Rakesh C. Arora, St. Boniface Hospital
- Investigators
- Jo-Ann V Sawatzky, PhD, Principal investigator, University of ManitobaRakesh C Arora, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914094
- Sponsor's protocol ID
- H2010:390
- Status last verified
- Apr 2023
- First submitted
- 22 Jul 2013
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-habilitation Program for Elective Coronary Artery Bypass Graft Surgery Patients
- ClinicalTrials.gov ID
- NCT01914094
- Acronym / sponsor ID
- H2010:390
- Keywords
- Preoperative care, Exercise therapy, Cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- St. Boniface HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 1 Aug 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.
Low levels of physical fitness increase the risk of death in patients with cardiovascular disease. Although cardiac rehabilitation programs improve the health of patients after heart surgery, most patients are not referred until after surgery. Therefore, the purpose of this study was to determine if an exercise "pre-habilitation" (i.e., Prehab) program before heart surgery would improve the health of patients before surgery and whether these improvements would be maintained after surgery.
The investigators hypothesized that Prehab would promote the health of patients before heart surgery, and these improvements would be maintained three months post-operatively, as compared to patients who received standard care.
Detailed description
This was a single-centre, parallel randomized controlled trial conducted in Canada to determine the feasibility and efficacy of an exercise and education "pre-habilitation" (i.e., Prehab) program before elective coronary artery bypass graft surgery (CABG). We recruited 17 patients who were scheduled to undergo elective CABG surgery from February 2011-May 2012. Enrolled patients were assessed at baseline, one week pre-operatively, and three months post-operatively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Received current standard care. |
| Prehab | Experimental | Behavioral: PrehabReceived pre-operative exercise therapy plus education classes concerning management of their risk factors for coronary artery disease at a local medical fitness facility. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- On elective waitlist for coronary artery bypass graft surgery with a minimum anticipated wait time of 4-6 weeks or more
- No history of unstable angina
- Canadian Cardiovascular Society score of less than 4
- No history of myocardial infarction within the past 7 days
- Ejection fraction greater than 30%
Key exclusion criteria (3 listed)
- If patients cannot attend Prehab due to geographical limitations
- If patients cannot participate due to physical limitations
- Diagnosis of exercise-induced arrhythmia
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 |
|---|---|---|
| PrehabAlso: Pre-habilitation, Preoperative exercise therapy | Behavioural | Prehab |
Primary outcome
Change in 6-minute walking distance
Time frame: Baseline; 1 week pre-operatively; 3 months post-operatively
Assessed using the 6-minute walking test. Output is distance. Change from baseline 6-minute walking distance was assessed at each follow-up time point.
6 secondary outcomes
Change in 5-meter gait speed
Time frame: Baseline; 1 week pre-operatively; 3 months post-operatively
Change in objectively measured physical activity
Time frame: Baseline; 1 week pre-operatively; 3 months post-operatively
Change in quality of life
Time frame: Baseline; 1 week pre-operatively; 3 months post-operatively
Change in depressive symptoms
Time frame: Baseline; 1 week pre-operatively; 3 months post-operatively
Change in exercise self-efficacy
Time frame: Baseline; 1 week pre-operatively; 3 months post-operatively
Change in cardiac anxiety
Time frame: Baseline; 1 week pre-operatively; 3 months post-operatively
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 28 Apr 2023.
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.
Jo-Ann V Sawatzky, PhD principal investigator
University of Manitoba
Rakesh C Arora, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehab in people with Patients Waiting for Elective Coronary Artery Bypass Graft Surgery, run by St. Boniface Hospital at 1 site in Canada.
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 11 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 28 Apr 2023. 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 Canada. 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 6-minute walking distance (time frame: Baseline; 1 week pre-operatively; 3 months post-operatively). 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 28 Apr 2023.