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

Primary Purpose

Coronary Heart Disease, Acute Myocardial Infarction: Rehabilitation Phase

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cardiovascular rehabilitation program using Kinect of Xbox
Cardiovascular rehabilitation program using paper manual
Educational component
Sponsored by
Ágata Sofia da Silva Vieira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Other

    Arm Label

    Experimental group 1

    Experimental group 2

    Control Group

    Arm Description

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

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

    Educational component

    Outcomes

    Primary Outcome Measures

    Cardiovascular fitness using the stress test
    Physical activity using the accelerometer
    Quality of life using Macnew (heart disease health-related quality of life questionnaire)
    Lipid Profile using laboratory tests
    Quality of life using EADS-21 (depression, anxiety and stress scale)

    Secondary Outcome Measures

    Balance using the One leg standing test
    Balance using Star Excursion Balance Test
    Kyphotic index using the flexicurve
    Cognitive function using the Trail Making Test
    Cognitive function using the Verbal Digit Span Test
    Cognitive function using the Stroop Test
    Weight using the balance of bioimpedance
    Total fat mass using the balance of bioimpedance
    Fat mass of the trunk using the balance of bioimpedance
    Lean body mass using the balance of bioimpedance
    Waist hip ratio using the tape measure
    Waist height ratio using the tape measure
    Food consumption patterns using the food frequency questionnaire
    Functional muscle strength of lower limb using the Sit-to-stand test

    Full Information

    First Posted
    April 18, 2016
    Last Updated
    April 27, 2016
    Sponsor
    Ágata Sofia da Silva Vieira
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02753829
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ágata Sofia da Silva Vieira

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Heart Disease, Acute Myocardial Infarction: Rehabilitation Phase

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group 1
    Arm Type
    Experimental
    Arm Description
    Cardiovascular rehabilitation program using Kinect of Xbox, in home care context,virtual format
    Arm Title
    Experimental group 2
    Arm Type
    Experimental
    Arm Description
    Cardiovascular rehabilitation program using paper manual, in home care context, conventional format
    Arm Title
    Control Group
    Arm Type
    Other
    Arm Description
    Educational component
    Intervention Type
    Procedure
    Intervention Name(s)
    Cardiovascular rehabilitation program using Kinect of Xbox
    Intervention Description
    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
    Intervention Name(s)
    Cardiovascular rehabilitation program using paper manual
    Intervention Description
    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
    Other
    Intervention Name(s)
    Educational component
    Intervention Description
    It was only given the educational component about the control of cardiovascular risk factors and was encouraged to carry out the daily walks.
    Primary Outcome Measure Information:
    Title
    Cardiovascular fitness using the stress test
    Time Frame
    9 months
    Title
    Physical activity using the accelerometer
    Time Frame
    9 months
    Title
    Quality of life using Macnew (heart disease health-related quality of life questionnaire)
    Time Frame
    6 months
    Title
    Lipid Profile using laboratory tests
    Time Frame
    9 months
    Title
    Quality of life using EADS-21 (depression, anxiety and stress scale)
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Balance using the One leg standing test
    Time Frame
    6 months
    Title
    Balance using Star Excursion Balance Test
    Time Frame
    6 months
    Title
    Kyphotic index using the flexicurve
    Time Frame
    6 months
    Title
    Cognitive function using the Trail Making Test
    Time Frame
    6 months
    Title
    Cognitive function using the Verbal Digit Span Test
    Time Frame
    6 months
    Title
    Cognitive function using the Stroop Test
    Time Frame
    6 months
    Title
    Weight using the balance of bioimpedance
    Time Frame
    6 months
    Title
    Total fat mass using the balance of bioimpedance
    Time Frame
    6 months
    Title
    Fat mass of the trunk using the balance of bioimpedance
    Time Frame
    6 months
    Title
    Lean body mass using the balance of bioimpedance
    Time Frame
    6 months
    Title
    Waist hip ratio using the tape measure
    Time Frame
    6 months
    Title
    Waist height ratio using the tape measure
    Time Frame
    6 months
    Title
    Food consumption patterns using the food frequency questionnaire
    Time Frame
    6 months
    Title
    Functional muscle strength of lower limb using the Sit-to-stand test
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ágata S Vieira
    Organizational Affiliation
    Universidade do Porto
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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