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Effect of Resistance Training in Adults With Complex Congenital Heart Disease

U

Umeå University

Status

Unknown

Conditions

Congenital Heart Defect

Treatments

Behavioral: Home based resistance training

Study type

Interventional

Funder types

Other

Identifiers

NCT02658266
GUCHUmU02

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Resistance training
Experimental group
Description:
Home based resistance training 12 weeks home based resistance training 3 times per week, 10-12 reps, 2 sets
Treatment:
Behavioral: Home based resistance training
Control group
No Intervention group
Description:
No instructed exercise training. Continue with habitual physical activity.

Trial contacts and locations

3

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Central trial contact

Bengt Johansson, MD, PhD; Camilla Sandberg, PhD stud

Data sourced from clinicaltrials.gov

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