Clinical trial NCT02658266: Effect of Resistance Training in Adults With Complex Congenital Heart Disease
Official title: Effect of Resistance Training in Adults With Complex Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Heart Defect
Keywords: resistance training
adult
muscle strength
muscle endurance
muscle metabolism
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2016-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in muscle strength (Newton, N)
timeFrame: Change from baseline muscle strength at 12 weeks follow-up
Secondary outcomes:
measure: Change in muscle endurance (number of repetitions)
timeFrame: Change from baseline muscle endurance at 12 weeks follow-up
measure: Change in total body skeletal muscle mass (kg)
timeFrame: Change from baseline total body skeletal muscle mass at 12 weeks follow-up
measure: Change in appendicular skeletal muscle mass (kg)
timeFrame: Change from baseline appendicular skeletal muscle mass at 12 weeks follow-up
measure: Change in body fat percentage
timeFrame: Change from baseline body fat percentage at 12 weeks follow-up
measure: Change in bone mineral density (g/cm2)
timeFrame: Change from baseline bone mineral density at 12 weeks follow-up
measure: Muscle metabolism
timeFrame: Change from baseline muscle metabolism at 12 weeks follow-up
Other outcomes:
measure: Compliance to study protocol
timeFrame: At completion of study protocol 12 weeks
measure: Adverse events
timeFrame: Once a week from the date of onset of the home based exercise regimen until the followup at 12 weeks
Locations:
city: Lund
country: Sweden
facility: Skåne University hospital
city: Umeå
country: Sweden
facility: University Hospital
city: Uppsala
country: Sweden
facility: University Hospital Uppsala
Study officials:
affiliation: Umea University
name: Bengt Johansson, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.