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Effect of Resistance Training in Adults With Complex Congenital Heart Disease

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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
Sponsor:
Information provided by (Responsible Party):
Umeå University

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Change in muscle strength (Newton, N) [ Time Frame: Change from baseline muscle strength at 12 weeks follow-up ]

Secondary Outcome Measures :
  1. Change in muscle endurance (number of repetitions) [ Time Frame: Change from baseline muscle endurance at 12 weeks follow-up ]
  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. Muscle metabolism [ Time Frame: Change from baseline muscle metabolism at 12 weeks follow-up ]
    near infrared spectroscopy (NIRS)


Other Outcome Measures:
  1. Compliance to study protocol [ Time Frame: At completion of study protocol 12 weeks ]
    number of training sessions

  2. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658266


Contacts
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Contact: Bengt Johansson, MD, PhD +46907852782 bengt.johansson@medicin.umu.se
Contact: Camilla Sandberg, PhD stud +46907858441 camilla.sandberg@medicin.umu.se

Locations
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Sweden
Skåne University hospital Completed
Lund, Sweden, 22185
University Hospital Recruiting
Umeå, Sweden, 90185
Contact: Bengt Johansson, MD, PhD    +46907852782    bengt.johansson@medicin.umu.se   
Contact: Camilla Sandberg, RPT, PhD    +46907858441    camilla.sandberg@medicin.umu.se   
Principal Investigator: Bengt Johansson, MD, PhD         
Sub-Investigator: Camilla Sandberg Sandberg, RPT, PhD         
University Hospital Uppsala Recruiting
Uppsala, Sweden
Contact: Christina Christersson, MD, PhD         
Sponsors and Collaborators
Umeå University
Investigators
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Principal Investigator: Bengt Johansson, MD, Phd Umea University
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT02658266    
Other Study ID Numbers: GUCHUmU02
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Umeå University:
resistance training
adult
muscle strength
muscle endurance
muscle metabolism
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities