Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT01483235
Status:
COMPLETED
Last Update Posted:
2011-12-02
First Post:
2011-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reduced Cardiac Rehabilitation Program
Sponsor:
Simon Fraser University
Organization:
Study Overview
Official Title:
Design, Implementation and Evaluation of a Reduced Cardiac Rehabilitation Program
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
rCRP
Brief 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. 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.
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:
1. 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)?
2. Will the reduced cardiac rehabilitation program have better adherence than the standard cardiac rehabilitation program?
The following research questions will be addressed:
1. 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)?
2. Will the reduced cardiac rehabilitation program have better adherence than the standard cardiac rehabilitation program?
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 37553 | OTHER | Simon Fraser University | View |