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

NCT02753829 | Completed

• 1 other identifier: ASV-88
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Heart Disease; Acute Myocardial Infarction: Rehabilitation Phase

Outcome Measures

Primary Outcomes (5)

• Cardiovascular fitness using the stress test

  9 months

• Physical activity using the accelerometer

  9 months

• Quality of life using Macnew (heart disease health-related quality of life questionnaire)

  6 months

• Lipid Profile using laboratory tests

  9 months

• Quality of life using EADS-21 (depression, anxiety and stress scale)

  6 months

Secondary Outcomes (14)

• Balance using the One leg standing test

  6 months

• Balance using Star Excursion Balance Test

  6 months

• Kyphotic index using the flexicurve

  6 months

• Cognitive function using the Trail Making Test

  6 months

• Cognitive function using the Verbal Digit Span Test

  6 months

Study Arms (3)

Experimental group 1

EXPERIMENTAL

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

Procedure: Cardiovascular rehabilitation program using Kinect of Xbox

Experimental group 2

EXPERIMENTAL

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

Procedure: Cardiovascular rehabilitation program using paper manual

Control Group

OTHER

Educational component

Other: Educational component

Interventions

Cardiovascular rehabilitation program using Kinect of Xbox 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 1

Cardiovascular rehabilitation program using paper manual 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

Educational component OTHER

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

Control Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ágata Sofia da Silva Vieira: lead

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Ágata S Vieira

  Universidade do Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PHD Student

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 28, 2016
• Study Start: September 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: July 1, 2015
• Last Updated: April 28, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share