Clinical trial NCT03605992: Home-based Cardiac Rehabilitation: Compliance and Effectiveness
Official title: Compliance, Viability and Effectiveness of Home Based Cardiac Rehabilitation: a Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Coronary Disease
Cardiac Disease
Keywords: Rehabilitation
Coronary artery disease
Home-based
Randomized Controlled Trial
Protocol
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Fundação de Amparo à Pesquisa do estado de Minas Gerais
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2018-07-30
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Patients with coronary disease submitted to angioplasty or myocardial revascularization surgery, or that had a heart attack, provided they are considered of a low and moderate risk for the practice of physical exercise of moderate intensity according to the stratification for the risk of events during a cardiovascular rehabilitation program
2. Clinical stability, according with the medical evaluation;
3. Residents of the Belo Horizonte's metropolitan region.

Exclusion Criteria:

1. Recent cardiac event or clinical decompensation (\<1month);
2. Presence of peripheral arterial occlusive disease with limitation degree that prevents the test of maximum exercise (emergence of claudication before the maximum cardiorespiratory fatigue);
3. Presence of chronic pulmonary disease (i.e. Chronic Obstructive Pulmonary Disease, pulmonary fibrosis, and pulmonary arterial hypertension of pre capillary etiology);
4. History of ventricular fibrillation or sustained ventricular tachycardia in the last year;
5. Presence of high risk criteria during the ergometric test;
6. Physical, cognitive, or social limitation that prevent the participation in a physical exercise program, and the comprehension of the use of the monitoring device.

Primary outcomes:
measure: Change in adherence on CR sessions
timeFrame: after 3 and 6 months of the intervention
Secondary outcomes:
measure: Cost
timeFrame: after 3 and 6 months of the intervention
measure: Usability
timeFrame: For TeleRehab group after 3 months of the intervention
measure: Change in morbidity
timeFrame: after 3 and 6 months of the intervention
measure: Change in quality of life
timeFrame: At baseline, after 3 and 6 months
measure: Change in scores of depression
timeFrame: At baseline, after 3 and 6 months
measure: Change in functional capacity
timeFrame: At baseline, after 3 and 6 months
measure: Change in level of physical activity
timeFrame: At baseline, after 3 and 6 months
measure: Change in Blood pressure
timeFrame: At baseline, after 3 and 6 months
measure: Change in Waist circumference
timeFrame: At baseline, after 3 and 6 months
measure: Change in fasting blood glucose
timeFrame: At baseline, after 3 and 6 months
measure: Change in glycated hemoglobin
timeFrame: At baseline, after 3 and 6 months
measure: Change in total cholesterol
timeFrame: At baseline, after 3 and 6 months
measure: Change in knowledge about coronary artery disease
timeFrame: At baseline, after 3 and 6 months
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal University of Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Raquel R Britto, Post doc
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ghisi GLM, Sandison N, Oh P. Development, pilot testing and psychometric validation of a short version of the coronary artery disease education questionnaire: The CADE-Q SV. Patient Educ Couns. 2016 Mar;99(3):443-447. doi: 10.1016/j.pec.2015.11.002. Epub 2015 Nov 7.
citation: Lima AP, Nascimento IO, Oliveira ACA, Martins THS, Pereira DAG, Britto RR. Home-Based Cardiac Rehabilitation in Brazil's Public Health Care: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Nov 7;8(11):e13901. doi: 10.2196/13901.