Effect of Resistance Training in Adults With Complex Congenital Heart Disease

September 13, 2017 updated by: Umeå University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, 22185
        • Completed
        • Skåne University Hospital
      • Umeå, Sweden, 90185
        • Recruiting
        • University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bengt Johansson, MD, PhD
        • Sub-Investigator:
          • Camilla Sandberg Sandberg, RPT, PhD
      • Uppsala, Sweden
        • Recruiting
        • University hospital Uppsala
        • Contact:
          • Christina Christersson, MD, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in muscle strength (Newton, N)
Time Frame: Change from baseline muscle strength at 12 weeks follow-up
Change from baseline muscle strength at 12 weeks follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in muscle endurance (number of repetitions)
Time Frame: Change from baseline muscle endurance at 12 weeks follow-up
Change from baseline muscle endurance at 12 weeks follow-up
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)
Change from baseline total body skeletal muscle mass at 12 weeks follow-up
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)
Change from baseline appendicular skeletal muscle mass at 12 weeks follow-up
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)
Change from baseline body fat percentage at 12 weeks follow-up
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)
Change from baseline bone mineral density at 12 weeks follow-up
Muscle metabolism
Time Frame: Change from baseline muscle metabolism at 12 weeks follow-up
near infrared spectroscopy (NIRS)
Change from baseline muscle metabolism at 12 weeks follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance to study protocol
Time Frame: At completion of study protocol 12 weeks
number of training sessions
At completion of study protocol 12 weeks
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
Once a week from the date of onset of the home based exercise regimen until the followup at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Investigators

  • Principal Investigator: Bengt Johansson, MD, Phd, Umeå University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

January 14, 2016

First Posted (Estimate)

January 18, 2016

Study Record Updates

Last Update Posted (Actual)

September 14, 2017

Last Update Submitted That Met QC Criteria

September 13, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUCHUmU02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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