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Clinical Trials/NCT02658266
NCT02658266
Unknown
Not Applicable

Effect of Resistance Training in Adults With Complex Congenital Heart Disease

Umeå University3 sites in 1 country40 target enrollmentFebruary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Defect
Sponsor
Umeå University
Enrollment
40
Locations
3
Primary Endpoint
Change in muscle strength (Newton, N)
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
February 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Change in muscle strength (Newton, N)

Time Frame: Change from baseline muscle strength at 12 weeks follow-up

Secondary Outcomes

  • Change in appendicular skeletal muscle mass (kg)(Change from baseline appendicular skeletal muscle mass at 12 weeks follow-up)
  • Muscle metabolism(Change from baseline muscle metabolism at 12 weeks follow-up)
  • Change in total body skeletal muscle mass (kg)(Change from baseline total body skeletal muscle mass at 12 weeks follow-up)
  • Change in body fat percentage(Change from baseline body fat percentage at 12 weeks follow-up)
  • Change in muscle endurance (number of repetitions)(Change from baseline muscle endurance at 12 weeks follow-up)
  • Change in bone mineral density (g/cm2)(Change from baseline bone mineral density at 12 weeks follow-up)

Study Sites (3)

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