Home-based Cardiovascular Rehabilitation, Maintenance Phase, in Subjects With Coronary Artery Disease

NCT ID: NCT02753829

Last Updated: 2016-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Heart Disease Acute Myocardial Infarction: Rehabilitation Phase

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group 1

Cardiovascular rehabilitation program using Kinect of Xbox, in home care context,virtual format

Group Type EXPERIMENTAL

Cardiovascular rehabilitation program using Kinect of Xbox

Intervention Type PROCEDURE

Participants perform a program of specific exercises. The exercise protocol was adapted to the home context and presented two progressive levels of intensity of exercise, having the second level being introduced after 3 months. The exercise protocol was performed at a moderate intensity, initiated, using data from the stress test, maximal heart rate, the Karvonnen formula, with 65% of the reserve heart rate, progressing for 70%.

It was given the educational component about the control of cardiovascular risk factors and was encouraged to carry out the daily walks.

Experimental group 2

Cardiovascular rehabilitation program using paper manual, in home care context, conventional format

Group Type EXPERIMENTAL

Cardiovascular rehabilitation program using paper manual

Intervention Type PROCEDURE

Participants perform a program of specific exercises. The exercise protocol was adapted to the home context and presented two progressive levels of intensity of exercise, having the second level being introduced after 3 months. The exercise protocol was performed at a moderate intensity, initiated, using data from the stress test, maximal heart rate, the Karvonnen formula, with 65% of the reserve heart rate, progressing for 70%.

It was given the educational component about the control of cardiovascular risk factors and was encouraged to carry out the daily walks.

Control Group

Educational component

Group Type OTHER

Educational component

Intervention Type OTHER

It was only given the educational component about the control of cardiovascular risk factors and was encouraged to carry out the daily walks.

Interventions

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Cardiovascular rehabilitation program using Kinect of Xbox

Participants perform a program of specific exercises. The exercise protocol was adapted to the home context and presented two progressive levels of intensity of exercise, having the second level being introduced after 3 months. The exercise protocol was performed at a moderate intensity, initiated, using data from the stress test, maximal heart rate, the Karvonnen formula, with 65% of the reserve heart rate, progressing for 70%.

It was given the educational component about the control of cardiovascular risk factors and was encouraged to carry out the daily walks.

Intervention Type PROCEDURE

Cardiovascular rehabilitation program using paper manual

Participants perform a program of specific exercises. The exercise protocol was adapted to the home context and presented two progressive levels of intensity of exercise, having the second level being introduced after 3 months. The exercise protocol was performed at a moderate intensity, initiated, using data from the stress test, maximal heart rate, the Karvonnen formula, with 65% of the reserve heart rate, progressing for 70%.

It was given the educational component about the control of cardiovascular risk factors and was encouraged to carry out the daily walks.

Intervention Type PROCEDURE

Educational component

It was only given the educational component about the control of cardiovascular risk factors and was encouraged to carry out the daily walks.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ágata Sofia da Silva Vieira

OTHER

Sponsor Role lead

Responsible Party

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Ágata Sofia da Silva Vieira

PHD Student

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ágata S Vieira

Role: PRINCIPAL_INVESTIGATOR

Universidade do Porto

Other Identifiers

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ASV-88

Identifier Type: -

Identifier Source: org_study_id

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