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
About this trial
This is an interventional treatment trial for Coronary Heart Disease
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
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
NCT ID
NCT02753829
First Posted
April 18, 2016
Last Updated
April 27, 2016
Sponsor
Ágata Sofia da Silva Vieira
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
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Home-based Cardiovascular Rehabilitation, Maintenance Phase, in Subjects With Coronary Artery Disease
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