Cardiovascular DiseaserCRPNCT01483235
Reduced Cardiac Rehabilitation Program
A study testing Reduced cardiac rehabilitation group intervention (rCRP). and Standard cardiac rehabilitation intervention in people with Cardiovascular Disease and Obesity, run by Simon Fraser University at 1 site in Canada.
Trial summary
Standard cardiac rehabilitation programs (sCRP) aim to improve risk factors for heart disease such as high blood pressure, weight control, exercise and diet in order to decrease the chances of having heart problems in the future. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Cardiovascular Disease, Obesity, Dyslipidemia
- What is being tested?
- Reduced cardiac rehabilitation group intervention (rCRP). and Standard cardiac rehabilitation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to Sep 2011
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women (equal distribution) with risk factors for ischemic heart disease (primary prevention) or documented ischemic heart disease (secondary prevention) accepted in the cardiac rehabilitation program of St. Paul's Hospital.
- Patients with documented ischemic heart disease (secondary prevention) classified as low and moderate risk according to the AACVPR risk stratification criteria for cardiac patients.
Who cannot join
- Patients with documented ischemic heart disease (secondary prevention)at high risk according to the AACVPR risk stratification criteria for cardiac patients.
- Patients will also be excluded if they have the following:
- Uncontrolled metabolic factors (renal failure, uncontrolled diabetes, endocrinopathies
- Scheduled revascularization
- Unable to provide informed consent
- Unlikely to survive due to non cardiac issues
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- Psychiatric conditions that would interfere with compliance.
- Center for Epidemiologic Studies Depression scale higher than 16 points.
- Those coming to the cardiac rehabilitation program due to congenital heart disease with no risk factors for ischemic heart disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Design, Implementation and Evaluation of a Reduced Cardiac Rehabilitation Program
Standard cardiac rehabilitation programs (sCRP) aim to improve risk factors for heart disease such as high blood pressure, weight control, exercise and diet in order to decrease the chances of having heart problems in the future. These programs decrease morbidity and mortality but face important challenges: 1) Long waiting lists to participate in these programs. For example, St. Paul's Hospital has an intake capacity of 480 patients per year. Patients usually wait one to three months to start the program. 2) There is a vast heterogeneity of patients within the same program, from those that have never experienced heart problems to those that have already had a heart attack, chest pain or stroke. Therefore, patients with different medical problems receive the same treatment. 3) Facilities can be inconveniently located which leads to transportation difficulties, 4) The program is time consuming and classes are held in working times, 5) Shortly after completion, patients seem to lose what they have gained in the program. These caveats need to be addressed to improve the efficacy, delivery and capacity of sCRP for the increasing population of patients with heart disease.
The investigators want to compare a reduced cardiac rehabilitation program (rCRP) with the standard cardiac rehabilitation program (sCRP) in patients with risk factors for heart disease as well as patients that already suffer from this condition, including those at higher risk. The rCRP will offer the same services as the sCRP; the only difference is the number of hospital based exercise sessions. While the sCRP offers 32 hospital based supervised exercise sessions, the rCRP will offer 10 hospital based exercise sessions. The rCRP would be a 'middle of the road alternative program' that would have the benefits of a hospital based program and the flexibility of a home based intervention. The rCRP would offer an alternative for patients that do not need constant supervision and would allow the sCRP health care team to focus on those patients who have more serious heart conditions. The rCRP would be a unique intervention because it integrates a less intensive cardiac rehabilitation into the pre-existing sCRP model. This alternative would help overcome the caveats of standard cardiac rehabilitation programs.
Read the detailed description
This study is a two group randomized controlled trial, non-inferiority design, where the rCRP (intervention group) will be compared with the sCRP (control group). Eligible patients will be asked to participate in the study at the cardiac rehabilitation program intake clinic. Consenting participants will be asked to sign an informed consent and undergo a baseline assessment. This assessment will consist of a medical history, exercise capacity (stress test), blood test, blood pressure, anthropometric measurements, lifestyle behaviours and psychosocial measurements. The baseline assessment will be done before participants start the program. Consecutively, randomization will take place stratified according to gender to either the sCRP or rCRP. The same assessment called exit assessment will be performed at four to six months from baseline, at the cardiac rehabilitation program exit clinic (at program completion) and at 16 to 20 months from baseline (one year follow-up from cardiac rehabilitation program completion) to assess the immediate and sustainable effect, respectively.
The following research questions will be addressed:
- Is the reduced cardiac rehabilitation program (intervention group) as effective as the standard cardiac rehabilitation program (control group) for improving exercise capacity and ischemic heart disease risk factors at both program completion (four to six months from baseline) and at one year from program completion (16 to 20 months from baseline)?
- Will the reduced cardiac rehabilitation program have better adherence than the standard cardiac rehabilitation program?
- Conditions
- Cardiovascular Disease, Obesity, Dyslipidemia
- Being tested
- Reduced cardiac rehabilitation group intervention (rCRP)., Standard cardiac rehabilitation intervention
- Keywords
- cardiac rehabilitation, prevention, exercise capacity
- Medical subject headings
- Cardiovascular Diseases, Obesity, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced cardiac rehabilitation group intervention (rCRP).Behavioural
Also called rCRP
The rCRP is a comprehensive intervention that will keep the same nature of therapies as the standard cardiac rehabilitation group (sCRP). The difference with the sCRP resides in the number of hospital based exercise sessions; instead of 32 sessions there will be 10 sessions spread throughout the 4 months of intervention (hence, not a shorter program). The rCRP intervention works within the sCRP. Hence, those randomized to the rCRP will be supervised in the same facility and by the same clinical staff as those in the sCRP. Patients from rCRP will receive individual exercise guidelines, an educational package with questions of the week and a diary to record their exercise sessions (logbook), that will serve as a self-monitoring system.
Standard cardiac rehabilitation interventionBehavioural
Also called sCRP
The standard cardiac rehabilitation is a multidisciplinary four-month intervention to modify ischemic heart disease risk factors and lifestyle behaviours. These programs aim to reduce morbidity and mortality by improving adherence to regular physical activity, a healthy diet and smoking cessation, as well as risk factor modification. Patients receive an initial intake evaluation by a cardiologist, nurse,exercise specialist and dietitian before starting the program. The program consists of 32, twice weekly in-hospital exercise sessions, educational sessions, nutritional counselling, medical care, psychological screening and smoking cessation if needed.
| Study group | Role | What they receive |
|---|---|---|
| Reduced cardiac rehabilitation (rCRP) | Experimental | The rCRP is the intervention group, compared to the standard cardiac rehabilitation program group (sCRP). The rCRP will have the core elements of the sCRP, that is, in-hospital exercise sessions, dietary counseling, educational sessions, follow-up with the cardiologist, dietician and exercise specialist. The only difference will be the number of in-hospital exercise sessions (10 sessions for the rCRP v/s 32 sessions for the sCRP). Patients from rCRP will receive individual exercise guidelines, an educational package with questions of the week and a diary to record their exercise sessions (logbook), that will serve as a self-monitoring system. Receives: Behavioral: Reduced cardiac rehabilitation group intervention (rCRP). |
| Standard cardiac rehabilitation (sCRP) | Active comparator | The standard cardiac rehabilitation (sCRP) follows the standard cardiac rehabilitation program model of a four-month period. Patients receive an initial intake evaluation by a cardiologist, nurse, exercise specialist and dietitian before starting the program. The program consists of 32, twice weekly in-hospital exercise sessions, educational sessions, nutritional counseling, medical care, psychological screening and smoking cessation if needed. Receives: Behavioral: Standard cardiac rehabilitation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Capacity
Exercise capacity will be determined through a symptom-limited maximal treadmill exercise test using the Bruce protocol and reported as total time in seconds in the treadmill. Participants will undergo continuous 12-lead ECG monitoring during the test. Participants will have their baseline, exit(program completion) and one-year (16 to 20 months from baseline) exercise stress tests conducted at the ECG stress laboratory at St. Paul's Hospital.
Measured: Data collection to be completed in September 2011
Secondary outcomes (5)
Metabolic risk factors.
Total cholesterol, HDL-C, triglycerides and blood glucose will be assessed from fasting blood samples. The Friedewald equation will be used to calculate LDL-C. To assess for change in global risk score, the Framingham risk score and the Progression of Disease risk score will be used for primary and secondary prevention patients respectively. Blood pressure will be measured with a manual sphyngomanometer. These outcomes will be assessed at baseline (program intake), program completion (four to six months from baseline) and at 16 to 20 months from baseline.
Measured: Data collection to be completed by September 2011
Lifestyle
Leisure time physical activity will be determined by the four-week modified Minnesota LTPA questionnaire and reported as the average weekly kilocalories (kcal/wk) expended through physical activity and exercise. Diet will be reported as percent daily kilocalories for fat, protein and carbohydrates using a three-day food record. Smoking status will be assessed by self-report. These outcomes will be measured at baseline (program intake), program completion (four to six months from baseline) and at 16 to 20 months from baseline.
Measured: Data collection to be completed in September 2011
Psychosocial measures
Health related Quality of life will be assessed by the Euro Quality of Life questionnaire. Self-efficacy will be assessed with the self-efficacy questionnaire that has two components: a general self-efficacy assessment and exercise-specific assessment. These outcomes will be measured at baseline (program intake), program completion (four to six months from baseline)and at 16 to 20 months from baseline.
Measured: Data to be collected by September 2011
Anthropometry
Body mass index will be calculated from weight in kilograms divided by height in metres squared. Waist circumference will be recorded in centimetres, taken at the point of maximal narrowing following a normal expiration. Hip circumference will be recorded in centimetres taken at the point of maximal gluteal protuberance. Waist to hip ratio will be calculated by simple division. These outcomes will be measured at baseline (program intake), program completion (four to six months from baseline) and at 16 to 20 months from baseline.
Measured: Data to be collected by September 2011
Program adherence
Assessed as percent attendance to in-hospital sessions. Overall physical activity adherence will be assessed with the LTPA questionnaire measured as weekly kilocalorie/week expended. This outcome will be measured at baseline (program intake), at program completion (four to six months from baseline)and at 16 to 20 months from baseline.
Measured: Data collection to be completed in September 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startSep 2006
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simon Fraser University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandra Farias-Godoy, Simon Fraser University
- Investigators
- Scott Lear, PhD, Principal investigator, Simon Fraser UniversityAlejandra Farias-Godoy, MD, MSc, Principal investigator, Simon Fraser University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483235
- Sponsor's protocol ID
- 37553
- Other IDs
- 37553
- Acronym
- rCRP
- Status last verified
- Dec 2011
- First submitted
- 28 Nov 2011
- Last updated
- 2 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design, Implementation and Evaluation of a Reduced Cardiac Rehabilitation Program
- ClinicalTrials.gov ID
- NCT01483235
- Acronym / sponsor ID
- rCRP / 37553
- Conditions
- Cardiovascular Disease, Obesity, Dyslipidemia
- Keywords
- cardiac rehabilitation, prevention, exercise capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Simon Fraser UniversityUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 1 Dec 2011 (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.
Standard cardiac rehabilitation programs (sCRP) aim to improve risk factors for heart disease such as high blood pressure, weight control, exercise and diet in order to decrease the chances of having heart problems in the future. These programs decrease morbidity and mortality but face important challenges: 1) Long waiting lists to participate in these programs. For example, St. Paul's Hospital has an intake capacity of 480 patients per year. Patients usually wait one to three months to start the program. 2) There is a vast heterogeneity of patients within the same program, from those that have never experienced heart problems to those that have already had a heart attack, chest pain or stroke. Therefore, patients with different medical problems receive the same treatment. 3) Facilities can be inconveniently located which leads to transportation difficulties, 4) The program is time consuming and classes are held in working times, 5) Shortly after completion, patients seem to lose what they have gained in the program. These caveats need to be addressed to improve the efficacy, delivery and capacity of sCRP for the increasing population of patients with heart disease.
The investigators want to compare a reduced cardiac rehabilitation program (rCRP) with the standard cardiac rehabilitation program (sCRP) in patients with risk factors for heart disease as well as patients that already suffer from this condition, including those at higher risk. The rCRP will offer the same services as the sCRP; the only difference is the number of hospital based exercise sessions. While the sCRP offers 32 hospital based supervised exercise sessions, the rCRP will offer 10 hospital based exercise sessions. The rCRP would be a 'middle of the road alternative program' that would have the benefits of a hospital based program and the flexibility of a home based intervention. The rCRP would offer an alternative for patients that do not need constant supervision and would allow the sCRP health care team to focus on those patients who have more serious heart conditions. The rCRP would be a unique intervention because it integrates a less intensive cardiac rehabilitation into the pre-existing sCRP model. This alternative would help overcome the caveats of standard cardiac rehabilitation programs.
Detailed description
This study is a two group randomized controlled trial, non-inferiority design, where the rCRP (intervention group) will be compared with the sCRP (control group). Eligible patients will be asked to participate in the study at the cardiac rehabilitation program intake clinic. Consenting participants will be asked to sign an informed consent and undergo a baseline assessment. This assessment will consist of a medical history, exercise capacity (stress test), blood test, blood pressure, anthropometric measurements, lifestyle behaviours and psychosocial measurements. The baseline assessment will be done before participants start the program. Consecutively, randomization will take place stratified according to gender to either the sCRP or rCRP. The same assessment called exit assessment will be performed at four to six months from baseline, at the cardiac rehabilitation program exit clinic (at program completion) and at 16 to 20 months from baseline (one year follow-up from cardiac rehabilitation program completion) to assess the immediate and sustainable effect, respectively.
The following research questions will be addressed:
- Is the reduced cardiac rehabilitation program (intervention group) as effective as the standard cardiac rehabilitation program (control group) for improving exercise capacity and ischemic heart disease risk factors at both program completion (four to six months from baseline) and at one year from program completion (16 to 20 months from baseline)?
- Will the reduced cardiac rehabilitation program have better adherence than the standard cardiac rehabilitation program?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced cardiac rehabilitation (rCRP) | Experimental | Behavioral: Reduced cardiac rehabilitation group intervention (rCRP).The rCRP is the intervention group, compared to the standard cardiac rehabilitation program group (sCRP). The rCRP will have the core elements of the sCRP, that is, in-hospital exercise sessions, dietary counseling, educational sessions, follow-up with the cardiologist, dietician and exercise specialist. The only difference will be the number of in-hospital exercise sessions (10 sessions for the rCRP v/s 32 sessions for the sCRP). Patients from rCRP will receive individual exercise guidelines, an educational package with questions of the week and a diary to record their exercise sessions (logbook), that will serve as a self-monitoring system. |
| Standard cardiac rehabilitation (sCRP) | Active comparator | Behavioral: Standard cardiac rehabilitation interventionThe standard cardiac rehabilitation (sCRP) follows the standard cardiac rehabilitation program model of a four-month period. Patients receive an initial intake evaluation by a cardiologist, nurse, exercise specialist and dietitian before starting the program. The program consists of 32, twice weekly in-hospital exercise sessions, educational sessions, nutritional counseling, medical care, psychological screening and smoking cessation if needed. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women (equal distribution) with risk factors for ischemic heart disease (primary prevention) or documented ischemic heart disease (secondary prevention) accepted in the cardiac rehabilitation program of St. Paul's Hospital.
- Patients with documented ischemic heart disease (secondary prevention) classified as low and moderate risk according to the AACVPR risk stratification criteria for cardiac patients.
Key exclusion criteria (9 listed)
- Patients with documented ischemic heart disease (secondary prevention)at high risk according to the AACVPR risk stratification criteria for cardiac patients.
- Patients will also be excluded if they have the following:
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 |
|---|---|---|
| Reduced cardiac rehabilitation group intervention (rCRP).Also: rCRPThe rCRP is a comprehensive intervention that will keep the same nature of therapies as the standard cardiac rehabilitation group (sCRP). The difference with the sCRP resides in the number of hospital based exercise sessions; instead of 32 sessions there will be 10 sessions spread throughout the 4 months of intervention (hence, not a shorter program). The rCRP intervention works within the sCRP. Hence, those randomized to the rCRP will be supervised in the same facility and by the same clinical staff as those in the sCRP. Patients from rCRP will receive individual exercise guidelines, an educational package with questions of the week and a diary to record their exercise sessions (logbook), that will serve as a self-monitoring system. | Behavioural | Reduced cardiac rehabilitation (rCRP) |
| Standard cardiac rehabilitation interventionAlso: sCRPThe standard cardiac rehabilitation is a multidisciplinary four-month intervention to modify ischemic heart disease risk factors and lifestyle behaviours. These programs aim to reduce morbidity and mortality by improving adherence to regular physical activity, a healthy diet and smoking cessation, as well as risk factor modification. Patients receive an initial intake evaluation by a cardiologist, nurse,exercise specialist and dietitian before starting the program. The program consists of 32, twice weekly in-hospital exercise sessions, educational sessions, nutritional counselling, medical care, psychological screening and smoking cessation if needed. | Behavioural | Standard cardiac rehabilitation (sCRP) |
Primary outcome
Exercise Capacity
Time frame: Data collection to be completed in September 2011
Exercise capacity will be determined through a symptom-limited maximal treadmill exercise test using the Bruce protocol and reported as total time in seconds in the treadmill. Participants will undergo continuous 12-lead ECG monitoring during the test. Participants will have their baseline, exit(program completion) and one-year (16 to 20 months from baseline) exercise stress tests conducted at the ECG stress laboratory at St. Paul's Hospital.
5 secondary outcomes
Metabolic risk factors.
Time frame: Data collection to be completed by September 2011
Lifestyle
Time frame: Data collection to be completed in September 2011
Psychosocial measures
Time frame: Data to be collected by September 2011
Anthropometry
Time frame: Data to be collected by September 2011
Program adherence
Time frame: Data collection to be completed in September 2011
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 2 Dec 2011.
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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.
Scott Lear, PhD principal investigator
Simon Fraser University
Alejandra Farias-Godoy, MD, MSc principal investigator
Simon Fraser University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced cardiac rehabilitation group intervention (rCRP). and Standard cardiac rehabilitation intervention in people with Cardiovascular Disease and Obesity, run by Simon Fraser University 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 2 inclusion and 9 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 2 Dec 2011. 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?
Exercise Capacity (time frame: Data collection to be completed in September 2011). 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 2 Dec 2011.