Effect of Resistance Training in Adults With Complex Congenital Heart Disease

Sponsor

Umeå University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02658266

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

13.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Defect	Behavioral: Home based resistance training	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Resistance Training in Adults With Complex Congenital Heart Disease

Study Start Date :

Feb 1, 2016

Anticipated Primary Completion Date :

Feb 1, 2018

Anticipated Study Completion Date :

Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Change in muscle strength (Newton, N) [Change from baseline muscle strength at 12 weeks follow-up]

Secondary Outcome Measures

Change in muscle endurance (number of repetitions) [Change from baseline muscle endurance 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]
Using dual-energy x-ray absorptiometry (DEXA)
Change in appendicular skeletal muscle mass (kg) [Change from baseline appendicular skeletal muscle mass at 12 weeks follow-up]
Using dual-energy x-ray absorptiometry (DEXA)
Change in body fat percentage [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) [Change from baseline bone mineral density at 12 weeks follow-up]
Using dual-energy x-ray absorptiometry (DEXA)
Muscle metabolism [Change from baseline muscle metabolism at 12 weeks follow-up]
near infrared spectroscopy (NIRS)

Other Outcome Measures

Compliance to study protocol [At completion of study protocol 12 weeks]
number of training sessions
Adverse events [Once a week from the date of onset of the home based exercise regimen until the followup at 12 weeks]
Complications to resistance training

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.