Effect of Resistance Training in Adults With Complex Congenital Heart Disease
|ClinicalTrials.gov Identifier: NCT02658266|
Recruitment Status : Unknown
Verified August 2016 by Umeå University.
Recruitment status was: Recruiting
First Posted : January 18, 2016
Last Update Posted : September 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Defect||Behavioral: Home based resistance training||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of Resistance Training in Adults With Complex Congenital Heart Disease|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||February 2019|
Experimental: Resistance training
Home based resistance training 12 weeks home based resistance training 3 times per week, 10-12 reps, 2 sets
Behavioral: Home based resistance training
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.
No Intervention: Control group
No instructed exercise training. Continue with habitual physical activity.
- Change in muscle strength (Newton, N) [ Time Frame: Change from baseline muscle strength at 12 weeks follow-up ]
- 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 ]Using dual-energy x-ray absorptiometry (DEXA)
- Change in appendicular skeletal muscle mass (kg) [ Time Frame: Change from baseline appendicular skeletal muscle mass at 12 weeks follow-up ]Using dual-energy x-ray absorptiometry (DEXA)
- Change in body fat percentage [ Time Frame: Change from baseline body fat percentage at 12 weeks follow-up ]Using dual-energy x-ray absorptiometry (DEXA)
- Change in bone mineral density (g/cm2) [ Time Frame: Change from baseline bone mineral density at 12 weeks follow-up ]Using dual-energy x-ray absorptiometry (DEXA)
- Muscle metabolism [ Time Frame: Change from baseline muscle metabolism at 12 weeks follow-up ]near infrared spectroscopy (NIRS)
- Compliance to study protocol [ Time Frame: At completion of study protocol 12 weeks ]number of training sessions
- Adverse events [ Time Frame: Once a week from the date of onset of the home based exercise regimen until the followup at 12 weeks ]Complications to resistance training
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658266
|Contact: Bengt Johansson, MD, PhDfirstname.lastname@example.org|
|Contact: Camilla Sandberg, PhD email@example.com|
|Skåne University hospital||Completed|
|Lund, Sweden, 22185|
|Umeå, Sweden, 90185|
|Contact: Bengt Johansson, MD, PhD +46907852782 firstname.lastname@example.org|
|Contact: Camilla Sandberg, RPT, PhD +46907858441 email@example.com|
|Principal Investigator: Bengt Johansson, MD, PhD|
|Sub-Investigator: Camilla Sandberg Sandberg, RPT, PhD|
|University Hospital Uppsala||Recruiting|
|Contact: Christina Christersson, MD, PhD|
|Principal Investigator:||Bengt Johansson, MD, Phd||Umea University|