Skip to main content
OpenTrials
Completed

NCT Number: NCT02753829

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Heart Disease Acute Myocardial Infarction: Rehabilitation Phase Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Cardiovascular fitness using the stress test

    Time frame: 9 months

  2. Physical activity using the accelerometer

    Time frame: 9 months

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

    Time frame: 6 months

  4. Lipid Profile using laboratory tests

    Time frame: 9 months

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

    Time frame: 6 months

Secondary outcomes

  1. Balance using the One leg standing test

    Time frame: 6 months

  2. Balance using Star Excursion Balance Test

    Time frame: 6 months

  3. Kyphotic index using the flexicurve

    Time frame: 6 months

  4. Cognitive function using the Trail Making Test

    Time frame: 6 months

  5. Cognitive function using the Verbal Digit Span Test

    Time frame: 6 months

  6. Cognitive function using the Stroop Test

    Time frame: 6 months

  7. Weight using the balance of bioimpedance

    Time frame: 6 months

  8. Total fat mass using the balance of bioimpedance

    Time frame: 6 months

  9. Fat mass of the trunk using the balance of bioimpedance

    Time frame: 6 months

  10. Lean body mass using the balance of bioimpedance

    Time frame: 6 months

  11. Waist hip ratio using the tape measure

    Time frame: 6 months

  12. Waist height ratio using the tape measure

    Time frame: 6 months

  13. Food consumption patterns using the food frequency questionnaire

    Time frame: 6 months

  14. Functional muscle strength of lower limb using the Sit-to-stand test

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Ágata Sofia da Silva Vieira

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Apr 28, 2016
Registry last updated
Apr 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.