Effect of Resistance Training in Adults With Complex Congenital Heart

Status Recruiting

Clinical 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. The hypotheses of the present study is that home based resistance training will improve muscle function in adults with different complex congenital hear diseases.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02658266
Study type	Interventional
Source	Umeå University
Contact	Bengt Johansson, MD, PhD
Phone	+46907852782
Email	bengt.johansson@medicin.umu.se
Status	Recruiting
Phase	N/A
Start date	February 2016
Completion date	February 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Resistance Training in Adults With Complex Congenital Heart Disease

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms