Clinical trial NCT02753829: Home-based Cardiovascular Rehabilitation, Maintenance Phase, in Subjects With Coronary Artery Disease
Official title: Home-based Cardiovascular Rehabilitation, Maintenance Phase, in Subjects With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Acute Myocardial Infarction: Rehabilitation Phase
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 33
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The sample of this randomized controlled trial was obtained in the Cardiovascular Prevention and Rehabilitation Unit, of the Hospital Centre of Porto, Santo Antonio General Hospital. The target population was individuals who have completed the training phase of cardiovascular rehabilitation program, volunteers and referenced by the responsible for the service.

This study has as main objective to analyze the influence of a specific exercise program, maintenance phase of cardiovascular rehabilitation , in home care context, for a period of 6 months, using a virtual format (computer and Kinect) or a conventional format (paper manual) in subjects with coronary artery disease. It was intended to analyze the immediate effect of exercise program on body composition and food consumption patterns, functional muscle strength of lower limb, level of physical activity: total volume of activity as well as the profile of this intensity, kyphotic index, balance, cognitive and executive function, as well as in the quality of life.

The aim is also to examine the effects, approximately 3 months after the end of the exercise program, in the lipid profile, the level of physical activity: total volume of activity as well as the profile of this intensity and cardiovascular fitness: maximum double product ; metabolic equivalents; and proof and recovery time.

The individuals were distributed at random, every 3 individuals, using the capabilities of Microsoft Excel 2010 RANDBETWEEN command, by three groups: the experimental group 1- a cardiovascular rehabilitation program, in home care context, using a computer and Kinect, virtual format, the experimental group 2- in cardiovascular rehabilitation program, in home care context, using a paper-based manual, conventional format, and control group-only subject to education for cardiovascular risk factors.

The program defined 3 training sessions per week. The rehabilitation program was oriented by the guidelines for exercise prescription.

Participants perform the a program of specific exercises independently and individually, with remote supervision, using communication (phone, email, etc.) and a routine scheduled individual meetings.


Eligibility criteria: Inclusion Criteria:

* coronary artery disease diagnosed and stabilized
* both sexes
* aged between 40 and 75 years
* individuals were to have performed and completed the training phase of cardiovascular rehabilitation
* individuals should have a computer with at least Microsoft Windows 7

Exclusion Criteria:

* heart surgery
* individuals whose stress test did not end for maximum fatigue
* individuals in gestation period or wishing to become pregnant
* individuals classified as cardiovascular high-risk
* individuals with pacemakers or with severe neurological, musculoskeletal or respiratory diseases and metabolic unbalanced disease or reported dementia, cardiomyopathies, history of cardio respiratory arrest don't associated with acute myocardial infarction or cardiac procedures
* individuals with significant visual and auditory deficits not compensated
* individuals illiterate and / or without knowledge of Portuguese language
* Individuals who were in, or wanted to do gyms or other regular exercise programs during the study

Primary outcomes:
measure: Cardiovascular fitness using the stress test
timeFrame: 9 months
measure: Physical activity using the accelerometer
timeFrame: 9 months
measure: Quality of life using Macnew (heart disease health-related quality of life questionnaire)
timeFrame: 6 months
measure: Lipid Profile using laboratory tests
timeFrame: 9 months
measure: Quality of life using EADS-21 (depression, anxiety and stress scale)
timeFrame: 6 months
Secondary outcomes:
measure: Balance using the One leg standing test
timeFrame: 6 months
measure: Balance using Star Excursion Balance Test
timeFrame: 6 months
measure: Kyphotic index using the flexicurve
timeFrame: 6 months
measure: Cognitive function using the Trail Making Test
timeFrame: 6 months
measure: Cognitive function using the Verbal Digit Span Test
timeFrame: 6 months
measure: Cognitive function using the Stroop Test
timeFrame: 6 months
measure: Weight using the balance of bioimpedance
timeFrame: 6 months
measure: Total fat mass using the balance of bioimpedance
timeFrame: 6 months
measure: Fat mass of the trunk using the balance of bioimpedance
timeFrame: 6 months
measure: Lean body mass using the balance of bioimpedance
timeFrame: 6 months
measure: Waist hip ratio using the tape measure
timeFrame: 6 months
measure: Waist height ratio using the tape measure
timeFrame: 6 months
measure: Food consumption patterns using the food frequency questionnaire
timeFrame: 6 months
measure: Functional muscle strength of lower limb using the Sit-to-stand test
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Universidade do Porto
name: Ágata S Vieira
role: PRINCIPAL_INVESTIGATOR
References: