Coronary Heart DiseaseNCT02753829
Home-based Cardiovascular Rehabilitation, Maintenance Phase, in Subjects With Coronary Artery Disease
A study testing Cardiovascular rehabilitation program using Kinect of Xbox, Cardiovascular rehabilitation program using paper manual and Educational component in people with Coronary Heart Disease and Acute Myocardial Infarction: Rehabilitation Phase, run by Ágata Sofia da Silva Vieira.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Coronary Heart Disease, Acute Myocardial Infarction: Rehabilitation Phase
- What is being tested?
- Cardiovascular rehabilitation program using Kinect of Xbox, Cardiovascular rehabilitation program using paper manual and Educational component
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read more
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.
- Being tested
- Cardiovascular rehabilitation program using Kinect of Xbox, Cardiovascular rehabilitation program using paper manual, Educational component
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular rehabilitation program using Kinect of XboxProcedure or surgery
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 manualProcedure or surgery
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 componentOther
It was only given the educational component about the control of cardiovascular risk factors and was encouraged to carry out the daily walks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1 | Experimental | Cardiovascular rehabilitation program using Kinect of Xbox, in home care context,virtual format Receives: Procedure: Cardiovascular rehabilitation program using Kinect of Xbox |
| Experimental group 2 | Experimental | Cardiovascular rehabilitation program using paper manual, in home care context, conventional format Receives: Procedure: Cardiovascular rehabilitation program using paper manual |
| Control Group | Other | Educational component Receives: Other: Educational component |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular fitness using the stress test
Measured: 9 months
Physical activity using the accelerometer
Measured: 9 months
Quality of life using Macnew (heart disease health-related quality of life questionnaire)
Measured: 6 months
Lipid Profile using laboratory tests
Measured: 9 months
Quality of life using EADS-21 (depression, anxiety and stress scale)
Measured: 6 months
Secondary outcomes (14)
Balance using the One leg standing test
Measured: 6 months
Balance using Star Excursion Balance Test
Measured: 6 months
Kyphotic index using the flexicurve
Measured: 6 months
Cognitive function using the Trail Making Test
Measured: 6 months
Cognitive function using the Verbal Digit Span Test
Measured: 6 months
Cognitive function using the Stroop Test
Measured: 6 months
Weight using the balance of bioimpedance
Measured: 6 months
Total fat mass using the balance of bioimpedance
Measured: 6 months
Fat mass of the trunk using the balance of bioimpedance
Measured: 6 months
Lean body mass using the balance of bioimpedance
Measured: 6 months
Waist hip ratio using the tape measure
Measured: 6 months
Waist height ratio using the tape measure
Measured: 6 months
Food consumption patterns using the food frequency questionnaire
Measured: 6 months
Functional muscle strength of lower limb using the Sit-to-stand test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startSep 2013
- Primary completionDec 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ágata Sofia da Silva Vieira
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ágata Sofia da Silva Vieira, Universidade do Porto
- Investigators
- Ágata S Vieira, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753829
- Sponsor's protocol ID
- ASV-88
- Status last verified
- Apr 2016
- First submitted
- 18 Apr 2016
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Cardiovascular Rehabilitation, Maintenance Phase, in Subjects With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02753829
- Acronym / sponsor ID
- ASV-88
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ágata Sofia da Silva VieiraUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 | Experimental | Procedure: Cardiovascular rehabilitation program using Kinect of XboxCardiovascular rehabilitation program using Kinect of Xbox, in home care context,virtual format |
| Experimental group 2 | Experimental | Procedure: Cardiovascular rehabilitation program using paper manualCardiovascular rehabilitation program using paper manual, in home care context, conventional format |
| Control Group | Other | Other: Educational componentEducational component |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular rehabilitation program using Kinect of XboxParticipants 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. | Procedure or surgery | Experimental group 1 |
| Cardiovascular rehabilitation program using paper manualParticipants 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. | Procedure or surgery | Experimental group 2 |
| Educational componentIt was only given the educational component about the control of cardiovascular risk factors and was encouraged to carry out the daily walks. | Other | Control Group |
Primary outcome
Cardiovascular fitness using the stress test
Time frame: 9 months
Physical activity using the accelerometer
Time frame: 9 months
Quality of life using Macnew (heart disease health-related quality of life questionnaire)
Time frame: 6 months
Lipid Profile using laboratory tests
Time frame: 9 months
Quality of life using EADS-21 (depression, anxiety and stress scale)
Time frame: 6 months
14 secondary outcomes
Balance using the One leg standing test
Time frame: 6 months
Balance using Star Excursion Balance Test
Time frame: 6 months
Kyphotic index using the flexicurve
Time frame: 6 months
Cognitive function using the Trail Making Test
Time frame: 6 months
Cognitive function using the Verbal Digit Span Test
Time frame: 6 months
Cognitive function using the Stroop Test
Time frame: 6 months
Weight using the balance of bioimpedance
Time frame: 6 months
Total fat mass using the balance of bioimpedance
Time frame: 6 months
Fat mass of the trunk using the balance of bioimpedance
Time frame: 6 months
Lean body mass using the balance of bioimpedance
Time frame: 6 months
Waist hip ratio using the tape measure
Time frame: 6 months
Waist height ratio using the tape measure
Time frame: 6 months
Food consumption patterns using the food frequency questionnaire
Time frame: 6 months
Functional muscle strength of lower limb using the Sit-to-stand test
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ágata S Vieira principal investigator
Universidade do Porto
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovascular rehabilitation program using Kinect of Xbox, Cardiovascular rehabilitation program using paper manual and Educational component in people with Coronary Heart Disease and Acute Myocardial Infarction: Rehabilitation Phase, run by Ágata Sofia da Silva Vieira.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular fitness using the stress test (time frame: 9 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2016.