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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistance training | Experimental | Home 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home based resistance training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in muscle strength (Newton, N) | Change from baseline muscle strength at 12 weeks follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in muscle endurance (number of repetitions) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance to study protocol | number of training sessions | At completion of study protocol 12 weeks |
| Adverse events | Complications to resistance training |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bengt Johansson, MD, PhD | Contact | +46907852782 | bengt.johansson@medicin.umu.se | |
| Camilla Sandberg, PhD stud | Contact | +46907858441 | camilla.sandberg@medicin.umu.se |
| Name | Affiliation | Role |
|---|---|---|
| Bengt Johansson, MD, Phd | Umea University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skåne University hospital | Completed | Lund | 22185 | Sweden | ||
| University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25038081 | Background | 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. | |
| 23846614 | Background | Cordina 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. |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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|
| 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) | Change from baseline appendicular skeletal muscle mass at 12 weeks follow-up |
| Change in body fat percentage | Using dual-energy x-ray absorptiometry (DEXA) | 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) | Change from baseline bone mineral density at 12 weeks follow-up |
| Muscle metabolism | near infrared spectroscopy (NIRS) | Change from baseline muscle metabolism at 12 weeks follow-up |
| Once a week from the date of onset of the home based exercise regimen until the followup at 12 weeks |
| Recruiting |
| Umeå |
| 90185 |
| Sweden |
|
| University Hospital Uppsala | Recruiting | Uppsala | Sweden |
|
| 24295897 | Background | Kroonstrom 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. |
| 25838217 | Background | Sandberg 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. |
| 33112424 | Derived | Williams 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. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |