Congenital Heart DefectsNCT01671566
Interval Training in Adults With Congenital Heart Disease a Randomized Trial
A study testing Home based interval training in people with Congenital Heart Defects, run by Umeå University at 2 sites in Sweden.
Trial summary
Adults with congenital heart disease have various degrees of impaired exercise capacity compared to healthy controls. Impaired exercise capacity makes everyday activities more difficult and demanding. There are few studies on effect of exercise training in adults with congenital heart disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Defects
- What is being tested?
- Home based interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesSweden
- Study dates
- Sep 2012to Mar 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complex congenital heart disease (e.g.; Tetralogy of Fallot, Transpositions of the great arteries, Ebstein, Eisenmenger, Pulmonary atresia or Tricuspid atresia)
- Clinically stable without significant change the last 3 months
- Adult (>18 years)
- Informed consent
Who cannot join
- Signs of arrhythmia on exercise ECG or relevant clinical arrhythmia
- Mental retardation or psychiatric illness affecting the ability of independent decisions
- Other comorbidity affecting physical activity
- Other circumstances making participation unsuitable
- Present strategy of regularly executing physical exercise > 2 times/week in purpose to increase cardiovascular capacity.
- VO2 peak > 30 ml/kg/min
- No access to internet
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Sahlgrenska University hospital
Gothenburg, Gothenburg, SE- 413 45
University Hospital
Umeå, Umeå, 90185
About this study
Official title: Effect of Home Based Interval Training on Exercise Capacity and Quality of Life in Adults With Congenital Heart Disease - a Randomized Controlled Multicenter Trial
Adults with congenital heart disease have various degrees of impaired exercise capacity compared to healthy controls. Impaired exercise capacity makes everyday activities more difficult and demanding. There are few studies on effect of exercise training in adults with congenital heart disease. The hypothesis of this study is that structured home based exercise training will improve exercise capacity and health status in the studied population.
Read the detailed description
The number adults with congenital heart disease is increasing. Thanks to advances in the medical and surgical fields the number of adults with complex congenital heart disease is now higher than the children with corresponding heart disease. Though the long term prognosis is still unknown and continuously changing as new therapeutic options are introduced.
Persons with congenital heart disease have different degrees of impaired exercise capacity compared to healthy controls. Some studies indicate that this population is not sufficiently active to achieve the recommendations for physical activity in preventing acquired heart disease. Physical inactivity is an important risk factor for developing acquired heart disease and other life style diseases as obesity and diabetes. In a population where one or more previous cardiac surgeries are common, the prevention of life style diseases is especially important. Exercise training in heart failure and coronary artery disease is well studied and there are clinical guidelines. Regarding exercise training in adults with congenital heart disease, however,the information is sparse and further studies are needed.
Based on defined inclusion and exclusion criteria adults with complex congenital heart disease will be recruited in the Northern Health Care Region in Sweden and in Gothenburg. Before and after the twelve week intervention period the investigators will collect information about cardiopulmonary exercise capacity, health related quality of life, exercise self-efficacy, anxiety and depression. The patients will be randomized to twelve weeks of home based interval training or to a control group. The randomization ratio will be 2:1 (intervention:control). The control group will be instructed to continue with their habitual physical activities. The home based interval training program will be individualized based on the results of the exercise tests.
The aim of this study is to examine the effect of home based interval training on maximal and submaximal exercise capacity, quality of life, exercise self-efficacy, anxiety and depression.
- Conditions
- Congenital Heart Defects
- Being tested
- Home based interval training
- Keywords
- Congenital Heart defect, Exercise and Physical fitness, Rehabilitation, Quality of life, Behaviour
- Medical subject headings
- Heart Defects, Congenital, Motor Activity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home based interval trainingBehavioural
The participant in the intervention group will receive an individualized interval training program. The individualized adjustments in training load will be made from the results of the CPET-incremental and adjustments in training time from the results of the constant work rate 75% of peak work rate (Watt). The training will be home based and performed on a ergometer cycle 3 times a week for twelve weeks. During exercise they will wear a heart rate monitoring watch. The registered heart rate will be transferred to a webpage after the exercise session. Only the physiotherapist and participant have the access to this page. The physiotherapist and participant will have a weekly contact to promote compliance, provide feedback and if necessary adjust the training time or load. Progression in training load and time will be made when necessary to keep a relevant intensity.
| Study group | Role | What they receive |
|---|---|---|
| Home based interval training | Experimental | 12 weeks home based interval training Receives: Behavioral: Home based interval training |
| Control group | No intervention | No structured exercise training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak VO2 (ml/kg/min)
Comparison within and between groups
Measured: Before homebased interval exrecise regime and after completion (12 weeks)
Endurance time
at CPET-incremental and constant work rate test at 75% of peak work rate (Watt). Comparison between and within groups.
Measured: Before homebased interval exercise regimen and at completion (12 weeks)
Secondary outcomes (12)
Response during CPET incremental and constant work rate test at 75% of peak work rate (Watt).
(Peak VO2 (l/min) and Iso time, VCO2, VE/VCO2, VE/VCO2-slope, anaerobic threshold, Peak Heart Rate, Heart Rate recovery, Heart Rate response, Peak work rate, Oxygen saturation, Blood pressure, symptoms) Comparison within and between groups.
Measured: Before homebased interval exercise regime and at completion (12 weeks)
Adverse events
Complications to training
Measured: Once a week during homebased exercise regime
Quality of life
The EQ-5D and SF 36 questionaires will be used to assess Quality of life. Comparison between and within groups.
Measured: Before homebased interval exercise regime and at completion (12 weeks)
Physical activity level
The long self administered version of International Physical Activity Questionaire (IPAQ) will be used to assess physical activity level. Comparison within and between groups.
Measured: Before homebased interval exercise regime and after completion (12 weeks)
Exercise self-efficacy
The Exercise Self-Efficacy Scale will be used. Comparison within and between groups
Measured: Before homebased interval exercise regime and after completion
Anxiety and depression
The hospital anxiety and depression scale (HAD-scale) will be used to estimate the incidence of anxiety and depression. Comparison between and within groups.
Measured: Before homebased interval exercise regime and after completion (12 weeks)
Response during CPET incremental and constant work rate test at 75 % of peak work rate (Watt).
( Peak VO2 and Iso time(l/min), VCO2, VE/VCO2, VE/VCO-slope, anaerobic threshold, Peak Heart Rate, Heart Rate recovery, Heart rate response, Peak work rate, Oxygen saturation, Blood pressure, symptoms) Comparison within and between groups.
Measured: 12 months after completion
Peak VO2( ml/kg/min)
Comparison within and between groups
Measured: 12 months after completion
Endurance time
at CPET incremental and constant work rate at 75% of peak work rate (Watt)
Measured: 12 months after completion
Quality of life
The EQ-5D and SF 36 questionaires will be used to assess Quality of life. Comparison within and between groups.
Measured: 12 months after completion
Physical Activity level
The long self administered version of International Physical Activity Questionaire (IPAQ) will be used to assess physical activity level. Comparison within and between groups.
Measured: 12 months after completion
Anxiety and depression
The hospital Anxiety and Depression Scale (HAD-scale) will be used to estimate the incidence of anxiety and depression. Comparison within and between groups.
Measured: 12 months after completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DefectsStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bengt Johansson, Umeå University
- Investigators
- Bengt Johansson, MD, Phd, Principal investigator, Umea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671566
- Sponsor's protocol ID
- GUCHUmU01
- Status last verified
- Mar 2016
- First submitted
- 20 Aug 2012
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Home Based Interval Training on Exercise Capacity and Quality of Life in Adults With Congenital Heart Disease - a Randomized Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT01671566
- Acronym / sponsor ID
- GUCHUmU01
- Conditions
- Congenital Heart Defects
- Keywords
- Congenital Heart defect, Exercise and Physical fitness, Rehabilitation, Quality of life, Behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Aug 2012 (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.
Adults with congenital heart disease have various degrees of impaired exercise capacity compared to healthy controls. Impaired exercise capacity makes everyday activities more difficult and demanding. There are few studies on effect of exercise training in adults with congenital heart disease. The hypothesis of this study is that structured home based exercise training will improve exercise capacity and health status in the studied population.
Detailed description
The number adults with congenital heart disease is increasing. Thanks to advances in the medical and surgical fields the number of adults with complex congenital heart disease is now higher than the children with corresponding heart disease. Though the long term prognosis is still unknown and continuously changing as new therapeutic options are introduced.
Persons with congenital heart disease have different degrees of impaired exercise capacity compared to healthy controls. Some studies indicate that this population is not sufficiently active to achieve the recommendations for physical activity in preventing acquired heart disease. Physical inactivity is an important risk factor for developing acquired heart disease and other life style diseases as obesity and diabetes. In a population where one or more previous cardiac surgeries are common, the prevention of life style diseases is especially important. Exercise training in heart failure and coronary artery disease is well studied and there are clinical guidelines. Regarding exercise training in adults with congenital heart disease, however,the information is sparse and further studies are needed.
Based on defined inclusion and exclusion criteria adults with complex congenital heart disease will be recruited in the Northern Health Care Region in Sweden and in Gothenburg. Before and after the twelve week intervention period the investigators will collect information about cardiopulmonary exercise capacity, health related quality of life, exercise self-efficacy, anxiety and depression. The patients will be randomized to twelve weeks of home based interval training or to a control group. The randomization ratio will be 2:1 (intervention:control). The control group will be instructed to continue with their habitual physical activities. The home based interval training program will be individualized based on the results of the exercise tests.
The aim of this study is to examine the effect of home based interval training on maximal and submaximal exercise capacity, quality of life, exercise self-efficacy, anxiety and depression.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home based interval training | Experimental | Behavioral: Home based interval training12 weeks home based interval training |
| Control group | No intervention | –No structured exercise training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Complex congenital heart disease (e.g.; Tetralogy of Fallot, Transpositions of the great arteries, Ebstein, Eisenmenger, Pulmonary atresia or Tricuspid atresia)
- Clinically stable without significant change the last 3 months
- Adult (>18 years)
- Informed consent
Key exclusion criteria (7 listed)
- Signs of arrhythmia on exercise ECG or relevant clinical arrhythmia
- Mental retardation or psychiatric illness affecting the ability of independent decisions
- Other comorbidity affecting physical activity
- Other circumstances making participation unsuitable
- Present strategy of regularly executing physical exercise > 2 times/week in purpose to increase cardiovascular capacity.
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 |
|---|---|---|
| Home based interval trainingThe participant in the intervention group will receive an individualized interval training program. The individualized adjustments in training load will be made from the results of the CPET-incremental and adjustments in training time from the results of the constant work rate 75% of peak work rate (Watt). The training will be home based and performed on a ergometer cycle 3 times a week for twelve weeks. During exercise they will wear a heart rate monitoring watch. The registered heart rate will be transferred to a webpage after the exercise session. Only the physiotherapist and participant have the access to this page. The physiotherapist and participant will have a weekly contact to promote compliance, provide feedback and if necessary adjust the training time or load. Progression in training load and time will be made when necessary to keep a relevant intensity. | Behavioural | Home based interval training |
Primary outcome
Peak VO2 (ml/kg/min)
Time frame: Before homebased interval exrecise regime and after completion (12 weeks)
Comparison within and between groups
Endurance time
Time frame: Before homebased interval exercise regimen and at completion (12 weeks)
at CPET-incremental and constant work rate test at 75% of peak work rate (Watt). Comparison between and within groups.
12 secondary outcomes
Response during CPET incremental and constant work rate test at 75% of peak work rate (Watt).
Time frame: Before homebased interval exercise regime and at completion (12 weeks)
Adverse events
Time frame: Once a week during homebased exercise regime
Quality of life
Time frame: Before homebased interval exercise regime and at completion (12 weeks)
Physical activity level
Time frame: Before homebased interval exercise regime and after completion (12 weeks)
Exercise self-efficacy
Time frame: Before homebased interval exercise regime and after completion
Anxiety and depression
Time frame: Before homebased interval exercise regime and after completion (12 weeks)
Response during CPET incremental and constant work rate test at 75 % of peak work rate (Watt).
Time frame: 12 months after completion
Peak VO2( ml/kg/min)
Time frame: 12 months after completion
Endurance time
Time frame: 12 months after completion
Quality of life
Time frame: 12 months after completion
Physical Activity level
Time frame: 12 months after completion
Anxiety and depression
Time frame: 12 months after completion
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 4 Mar 2016.
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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.
Bengt Johansson, MD, Phd principal investigator
Umea University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home based interval training in people with Congenital Heart Defects, run by Umeå University at 2 sites in Sweden.
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 4 inclusion and 7 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 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Peak VO2 (ml/kg/min) (time frame: Before homebased interval exrecise regime and after completion (12 weeks)). The study lists 2 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 4 Mar 2016.