Congenital Heart DefectNCT02658266
Effect of Resistance Training in Adults With Complex Congenital Heart Disease
A study testing Home based resistance training in people with Congenital Heart Defect, run by Umeå University at 3 sites in Sweden.
Trial summary
Adults with complex congenital heart disease have impaired muscle function compared both to health controls and patients with lesions classified as simple. There is only one study assessing the effects of resistance training in patients palliated with Fontan procedure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Congenital Heart Defect
- What is being tested?
- Home based resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesSweden
- Study dates
- Feb 2016to Feb 2019
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complex congenital heart disease ( e.g. tetralogy of Fallot, transposition of the great arteries, pulmonary atresia, patients palliated with Fontan procedure or total cavo-pulmonary connection).
- Clinically stable without significant change the last 3 months.
- Adult (> 18 years of age).
- Informed consent.
Who cannot join
- Cognitive impairment affecting the ability of independent decision making.
- Present strategy of regularly executing resistance training > 2times per week in purpose to increase muscle strength.
- Other comorbidity affecting physical activity.
- Other circumstance making participation unsuitable.
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites, 2 recruiting
- Completed
Skåne University hospital
Lund, 22185
- Recruiting
University Hospital
Umeå, 90185
Bengt Johansson, MD, PhD, +46907852782, bengt.johansson@medicin.umu.se
Camilla Sandberg, RPT, PhD, +46907858441, camilla.sandberg@medicin.umu.se
- Recruiting
University Hospital Uppsala
Uppsala
Christina Christersson, MD, PhD
About this study
Adults with complex congenital heart disease have impaired muscle function compared both to health controls and patients with lesions classified as simple. There is only one study assessing the effects of resistance training in patients palliated with Fontan procedure. The hypotheses of the present study is that home based resistance training will improve muscle function in adults with different complex congenital hear diseases.
Read the detailed description
The number of adults with complex congenital heart disease is increasing and today they outnumber the children with corresponding lesions. However, the longterm prognosis is still unknown and continuously changing as new therapeutic options are introduced.
Patients with complex congenital heart disease have reduced muscle function compared to healthy controls as well as patients with lesions classified as simple. Furthermore, men with congenital heart disease are more commonly underweight and less commonly overweight obese compared to the general population. In addition, men with complex lesions are shorter in comparison to controls. This indicates an altered body composition i.e. muscle mass, fat mass and bone density in this population. Moreover, impaired muscle metabolism has been reported in patients palliated with Fontan procedure.
Adult patients with complex congenital heart disease will be recruited based on defined inclusion and exclusion criteria. Muscle function, muscle strength, muscle metabolism and body composition will be evaluated before randomisation and at follow-up after twelve weeks. The patients will be randomised to twelve weeks of home based resistance training or to a control group. The randomisation ratio will be 1:1 ( intervention:control). The control group will be instructed to continue with their habitual physical activities. The resistance training protocol will be individualised based on the results of the muscle function and muscle strength tests.
The aim of this study is to investigate the effects of resistance training on muscle function, muscle strength, body composition and muscle metabolism in adults with complex congenital heart disease.
- Conditions
- Congenital Heart Defect
- Being tested
- Home based resistance training
- Keywords
- resistance training, adult, muscle strength, muscle endurance, muscle metabolism
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home based resistance trainingBehavioural
The participants in the intervention group will receive an individualized resistance training program. The individual adjustments in load will will be made from the results of the muscle function and muscle strength tests. The resistance training will be home based and performed 3 times per week 10-12 reps 2 sets 12 weeks. Increment of load will be performed continuously according to rating of perceived exertion.
| Study group | Role | What they receive |
|---|---|---|
| Resistance training | Experimental | Home based resistance training 12 weeks home based resistance training 3 times per week, 10-12 reps, 2 sets Receives: Behavioral: Home based resistance training |
| Control group | No intervention | No instructed exercise training. Continue with habitual physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle strength (Newton, N)
Measured: Change from baseline muscle strength at 12 weeks follow-up
Secondary outcomes (6)
Change in muscle endurance (number of repetitions)
Measured: Change from baseline muscle endurance at 12 weeks follow-up
Change in total body skeletal muscle mass (kg)
Using dual-energy x-ray absorptiometry (DEXA)
Measured: Change from baseline total body skeletal muscle mass at 12 weeks follow-up
Change in appendicular skeletal muscle mass (kg)
Using dual-energy x-ray absorptiometry (DEXA)
Measured: Change from baseline appendicular skeletal muscle mass at 12 weeks follow-up
Change in body fat percentage
Using dual-energy x-ray absorptiometry (DEXA)
Measured: Change from baseline body fat percentage at 12 weeks follow-up
Change in bone mineral density (g/cm2)
Using dual-energy x-ray absorptiometry (DEXA)
Measured: Change from baseline bone mineral density at 12 weeks follow-up
Muscle metabolism
near infrared spectroscopy (NIRS)
Measured: Change from baseline muscle metabolism at 12 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DefectStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bengt Johansson, MD, Phd, Principal investigator, Umea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658266
- Sponsor's protocol ID
- GUCHUmU02
- Status last verified
- Aug 2016
- First submitted
- 11 Jan 2016
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sandberg C, Thilen U, Wadell K, Johansson B. Adults with complex congenital heart disease have impaired skeletal muscle function and reduced confidence in performing exercise training. Eur J Prev Cardiol. 2015 Dec;22(12):1523-30. doi: 10.1177/2047487314543076. Epub 2014 Jul 18.
PubMed 25038081Cordina R, O'Meagher S, Gould H, Rae C, Kemp G, Pasco JA, Celermajer DS, Singh N. Skeletal muscle abnormalities and exercise capacity in adults with a Fontan circulation. Heart. 2013 Oct;99(20):1530-4. doi: 10.1136/heartjnl-2013-304249. Epub 2013 Jul 11.
PubMed 23846614Kroonstrom LA, Johansson L, Zetterstrom AK, Dellborg M, Eriksson P, Cider A. Muscle function in adults with congenital heart disease. Int J Cardiol. 2014 Jan 1;170(3):358-63. doi: 10.1016/j.ijcard.2013.11.014. Epub 2013 Nov 13.
PubMed 24295897Sandberg C, Rinnstrom D, Dellborg M, Thilen U, Sorensson P, Nielsen NE, Christersson C, Wadell K, Johansson B. Height, weight and body mass index in adults with congenital heart disease. Int J Cardiol. 2015;187:219-26. doi: 10.1016/j.ijcard.2015.03.153. Epub 2015 Mar 18.
PubMed 25838217Williams CA, Wadey C, Pieles G, Stuart G, Taylor RS, Long L. Physical activity interventions for people with congenital heart disease. Cochrane Database Syst Rev. 2020 Oct 28;10(10):CD013400. doi: 10.1002/14651858.CD013400.pub2.
PubMed 33112424
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resistance Training in Adults With Complex Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT02658266
- Acronym / sponsor ID
- GUCHUmU02
- Conditions
- Congenital Heart Defect
- Keywords
- resistance training, adult, muscle strength, muscle endurance, muscle metabolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 18 Jan 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.
Adults with complex congenital heart disease have impaired muscle function compared both to health controls and patients with lesions classified as simple. There is only one study assessing the effects of resistance training in patients palliated with Fontan procedure. The hypotheses of the present study is that home based resistance training will improve muscle function in adults with different complex congenital hear diseases.
Detailed description
The number of adults with complex congenital heart disease is increasing and today they outnumber the children with corresponding lesions. However, the longterm prognosis is still unknown and continuously changing as new therapeutic options are introduced.
Patients with complex congenital heart disease have reduced muscle function compared to healthy controls as well as patients with lesions classified as simple. Furthermore, men with congenital heart disease are more commonly underweight and less commonly overweight obese compared to the general population. In addition, men with complex lesions are shorter in comparison to controls. This indicates an altered body composition i.e. muscle mass, fat mass and bone density in this population. Moreover, impaired muscle metabolism has been reported in patients palliated with Fontan procedure.
Adult patients with complex congenital heart disease will be recruited based on defined inclusion and exclusion criteria. Muscle function, muscle strength, muscle metabolism and body composition will be evaluated before randomisation and at follow-up after twelve weeks. The patients will be randomised to twelve weeks of home based resistance training or to a control group. The randomisation ratio will be 1:1 ( intervention:control). The control group will be instructed to continue with their habitual physical activities. The resistance training protocol will be individualised based on the results of the muscle function and muscle strength tests.
The aim of this study is to investigate the effects of resistance training on muscle function, muscle strength, body composition and muscle metabolism in adults with complex congenital heart disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance training | Experimental | Behavioral: Home based resistance trainingHome based resistance training 12 weeks home based resistance training 3 times per week, 10-12 reps, 2 sets |
| Control group | No intervention | –No instructed exercise training. Continue with habitual physical activity. |
Who may qualify
- Ages
- 18 to 70 years
- 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, transposition of the great arteries, pulmonary atresia, patients palliated with Fontan procedure or total cavo-pulmonary connection).
- Clinically stable without significant change the last 3 months.
- Adult (> 18 years of age).
- Informed consent.
Key exclusion criteria (4 listed)
- Cognitive impairment affecting the ability of independent decision making.
- Present strategy of regularly executing resistance training > 2times per week in purpose to increase muscle strength.
- Other comorbidity affecting physical activity.
- Other circumstance making participation unsuitable.
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 resistance trainingThe participants in the intervention group will receive an individualized resistance training program. The individual adjustments in load will will be made from the results of the muscle function and muscle strength tests. The resistance training will be home based and performed 3 times per week 10-12 reps 2 sets 12 weeks. Increment of load will be performed continuously according to rating of perceived exertion. | Behavioural | Resistance training |
Primary outcome
Change in muscle strength (Newton, N)
Time frame: Change from baseline muscle strength at 12 weeks follow-up
6 secondary outcomes
Change in muscle endurance (number of repetitions)
Time frame: Change from baseline muscle endurance at 12 weeks follow-up
Change in total body skeletal muscle mass (kg)
Time frame: Change from baseline total body skeletal muscle mass at 12 weeks follow-up
Change in appendicular skeletal muscle mass (kg)
Time frame: Change from baseline appendicular skeletal muscle mass at 12 weeks follow-up
Change in body fat percentage
Time frame: Change from baseline body fat percentage at 12 weeks follow-up
Change in bone mineral density (g/cm2)
Time frame: Change from baseline bone mineral density at 12 weeks follow-up
Muscle metabolism
Time frame: Change from baseline muscle metabolism at 12 weeks follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Background: PubMed 25038081Sandberg C, Thilen U, Wadell K, Johansson B. Adults with complex congenital heart disease have impaired skeletal muscle function and reduced confidence in performing exercise training. Eur J Prev Cardiol. 2015 Dec;22(12):1523-30. doi: 10.1177/2047487314543076. Epub 2014 Jul 18.
- Background: PubMed 23846614Cordina R, O'Meagher S, Gould H, Rae C, Kemp G, Pasco JA, Celermajer DS, Singh N. Skeletal muscle abnormalities and exercise capacity in adults with a Fontan circulation. Heart. 2013 Oct;99(20):1530-4. doi: 10.1136/heartjnl-2013-304249. Epub 2013 Jul 11.
- Background: PubMed 24295897Kroonstrom LA, Johansson L, Zetterstrom AK, Dellborg M, Eriksson P, Cider A. Muscle function in adults with congenital heart disease. Int J Cardiol. 2014 Jan 1;170(3):358-63. doi: 10.1016/j.ijcard.2013.11.014. Epub 2013 Nov 13.
- Background: PubMed 25838217Sandberg C, Rinnstrom D, Dellborg M, Thilen U, Sorensson P, Nielsen NE, Christersson C, Wadell K, Johansson B. Height, weight and body mass index in adults with congenital heart disease. Int J Cardiol. 2015;187:219-26. doi: 10.1016/j.ijcard.2015.03.153. Epub 2015 Mar 18.
- Derived from this study: PubMed 33112424Williams CA, Wadey C, Pieles G, Stuart G, Taylor RS, Long L. Physical activity interventions for people with congenital heart disease. Cochrane Database Syst Rev. 2020 Oct 28;10(10):CD013400. doi: 10.1002/14651858.CD013400.pub2.
- 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.
Bengt Johansson, MD, Phd principal investigator
Umea University
3 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 resistance training in people with Congenital Heart Defect, run by Umeå University at 3 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 4 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: status not confirmed, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bengt Johansson, MD, PhD (+46907852782, bengt.johansson@medicin.umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle strength (Newton, N) (time frame: Change from baseline muscle strength at 12 weeks follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02658266, which also lists 5 linked publications.
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 14 Sep 2017.