Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-26 @ 7:18 AM
Study NCT ID:
NCT03605992
Status:
COMPLETED
Last Update Posted:
2020-07-24
First Post:
2018-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home-based Cardiac Rehabilitation: Compliance and Effectiveness
Sponsor:
Federal University of Minas Gerais
Organization:
Study Overview
Official Title:
Compliance, Viability and Effectiveness of Home Based Cardiac Rehabilitation: a Randomised Trial
Status:
COMPLETED
Status Verified Date:
2020-07
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:
None
Brief Summary:
The proposal of this study is to verify if it is feasible and effective to offer a home based cardiac rehabilitation program, that includes the components of health education and physical exercises mostly unsupervised and oriented by telephone and to compare the treatment adherence, the effects in the functional capacity, and the control of coronary risk factors in relation to the traditional cardiac rehabilitation offered mostly supervised and center based.
Detailed Description:
This study will be developed with patients with coronary disease submitted to angioplasty or myocardial revascularization surgery, provided they are considered of low and moderate risk for the practice of physical exercise of moderate intensity, according to the risk stratification proposed by the American Association of Cardiovascular and Pulmonary Rehabilitation. Volunteers will be recruited at the outpatient at the University Hospital's Cardiac Rehabilitation Centre. The study will be made in conformity with the CONSORT guidelines for non-pharmacological interventions. After being invited to the study, the volunteer whose accept the participation and sign the consent form will be randomized into two different groups: Traditional cardiac rehabilitation (mostly supervised) and Telerehabilitation (mostly unsupervised). The randomization will be made through the www.randomization.com website in blocks of four volunteers each. A blind researcher will evaluate participants before and after test, and will fulfill the database.
Intervention The parameters for the exercise prescription will be the same for both groups. Exercise sessions will be constituted of 5-10 minutes of warm up, 40 minutes of aerobic activity with heart rate between 60 and 80% of the heart rate reserve, and 5-10 minutes of cool down. The educational sessions will be given to both groups in six meetings with 40 minutes each, and items regarding the control of risk factors and treatment of cardiovascular diseases will be approached. After the period of 12 weeks of intervention all participants will be stimulated to continue to practice physical exercises at home or at the community, and they will be invited to a re-evaluation after three months.
Groups:
Traditional cardiac rehabilitation as control group (CentreRehab) The CentreRehab group will be made supervised exercises and health educational activities, personally at cardiac rehabilitation centre. This intervention will last 12 weeks, with a total of 60 sessions: 24 supervised and 36 at home (to complete five exercise's sessions for week). The participants of this group will be oriented to fulfill a training diary with information regarding the frequency of the exercises, the presence of symptoms, and the use of the scale of perceived exertion during exercises at home.
Home-based cardiac rehabilitation (HomeRehab) The participants of the HomeRehab group will make the exercise mostly at home. There will be weekly phone calls, in person educational sessions, and monthly meetings to check the execution of the previous stage, solve doubts, or identify the presence of symptoms or undesirable effects. This intervention will have the duration of 12 weeks, with a total of 60 sessions: 2 supervised and 58 at home (to complete five exercise's sessions for week).
In the first week, all individuals of HomeRehab group will receive a training regarding the use of the monitoring equipment. A heart rate monitor with the heart rate zone individually calculated will be given to the participant at the first session of the face-to-face training to monitoring exercises at home. Furthermore, all participants of this group will use a step counter (pedometer) to stimulate the execution of the exercises as well as training diary to be fulfilled with information regarding the frequency of the exercises, the presence of symptoms during the exercise, the perceived exertion, and the number of daily steps. The monthly meetings will take place to the educational activity, and to verify if the exercises and fulfilment of the training diary are correct as well as to clarify any kind of the participant's doubts.
Intervention The parameters for the exercise prescription will be the same for both groups. Exercise sessions will be constituted of 5-10 minutes of warm up, 40 minutes of aerobic activity with heart rate between 60 and 80% of the heart rate reserve, and 5-10 minutes of cool down. The educational sessions will be given to both groups in six meetings with 40 minutes each, and items regarding the control of risk factors and treatment of cardiovascular diseases will be approached. After the period of 12 weeks of intervention all participants will be stimulated to continue to practice physical exercises at home or at the community, and they will be invited to a re-evaluation after three months.
Groups:
Traditional cardiac rehabilitation as control group (CentreRehab) The CentreRehab group will be made supervised exercises and health educational activities, personally at cardiac rehabilitation centre. This intervention will last 12 weeks, with a total of 60 sessions: 24 supervised and 36 at home (to complete five exercise's sessions for week). The participants of this group will be oriented to fulfill a training diary with information regarding the frequency of the exercises, the presence of symptoms, and the use of the scale of perceived exertion during exercises at home.
Home-based cardiac rehabilitation (HomeRehab) The participants of the HomeRehab group will make the exercise mostly at home. There will be weekly phone calls, in person educational sessions, and monthly meetings to check the execution of the previous stage, solve doubts, or identify the presence of symptoms or undesirable effects. This intervention will have the duration of 12 weeks, with a total of 60 sessions: 2 supervised and 58 at home (to complete five exercise's sessions for week).
In the first week, all individuals of HomeRehab group will receive a training regarding the use of the monitoring equipment. A heart rate monitor with the heart rate zone individually calculated will be given to the participant at the first session of the face-to-face training to monitoring exercises at home. Furthermore, all participants of this group will use a step counter (pedometer) to stimulate the execution of the exercises as well as training diary to be fulfilled with information regarding the frequency of the exercises, the presence of symptoms during the exercise, the perceived exertion, and the number of daily steps. The monthly meetings will take place to the educational activity, and to verify if the exercises and fulfilment of the training diary are correct as well as to clarify any kind of the participant's doubts.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: