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Effect of Resistance Training in Adults With Complex Congenital Heart Disease

Primary Purpose

Congenital Heart Defect

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Home based resistance training
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Defect focused on measuring resistance training, adult, muscle strength, muscle endurance, muscle metabolism

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Skåne University hospital
  • University HospitalRecruiting
  • University Hospital UppsalaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Resistance training

Control group

Arm Description

Home based resistance training 12 weeks home based resistance training 3 times per week, 10-12 reps, 2 sets

No instructed exercise training. Continue with habitual physical activity.

Outcomes

Primary Outcome Measures

Change in muscle strength (Newton, N)

Secondary Outcome Measures

Change in muscle endurance (number of repetitions)
Change in total body skeletal muscle mass (kg)
Using dual-energy x-ray absorptiometry (DEXA)
Change in appendicular skeletal muscle mass (kg)
Using dual-energy x-ray absorptiometry (DEXA)
Change in body fat percentage
Using dual-energy x-ray absorptiometry (DEXA)
Change in bone mineral density (g/cm2)
Using dual-energy x-ray absorptiometry (DEXA)
Muscle metabolism
near infrared spectroscopy (NIRS)

Full Information

First Posted
January 11, 2016
Last Updated
September 13, 2017
Sponsor
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT02658266
Brief Title
Effect of Resistance Training in Adults With Complex Congenital Heart Disease
Official Title
Effect of Resistance Training in Adults With Complex Congenital Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Umeå University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Defect
Keywords
resistance training, adult, muscle strength, muscle endurance, muscle metabolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Resistance training
Arm Type
Experimental
Arm Description
Home based resistance training 12 weeks home based resistance training 3 times per week, 10-12 reps, 2 sets
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No instructed exercise training. Continue with habitual physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Home based resistance training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in muscle strength (Newton, N)
Time Frame
Change from baseline muscle strength at 12 weeks follow-up
Secondary Outcome Measure Information:
Title
Change in muscle endurance (number of repetitions)
Time Frame
Change from baseline muscle endurance at 12 weeks follow-up
Title
Change in total body skeletal muscle mass (kg)
Description
Using dual-energy x-ray absorptiometry (DEXA)
Time Frame
Change from baseline total body skeletal muscle mass at 12 weeks follow-up
Title
Change in appendicular skeletal muscle mass (kg)
Description
Using dual-energy x-ray absorptiometry (DEXA)
Time Frame
Change from baseline appendicular skeletal muscle mass at 12 weeks follow-up
Title
Change in body fat percentage
Description
Using dual-energy x-ray absorptiometry (DEXA)
Time Frame
Change from baseline body fat percentage at 12 weeks follow-up
Title
Change in bone mineral density (g/cm2)
Description
Using dual-energy x-ray absorptiometry (DEXA)
Time Frame
Change from baseline bone mineral density at 12 weeks follow-up
Title
Muscle metabolism
Description
near infrared spectroscopy (NIRS)
Time Frame
Change from baseline muscle metabolism at 12 weeks follow-up
Other Pre-specified Outcome Measures:
Title
Compliance to study protocol
Description
number of training sessions
Time Frame
At completion of study protocol 12 weeks
Title
Adverse events
Description
Complications to resistance training
Time Frame
Once a week from the date of onset of the home based exercise regimen until the followup at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bengt Johansson, MD, PhD
Phone
+46907852782
Email
bengt.johansson@medicin.umu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Camilla Sandberg, PhD stud
Phone
+46907858441
Email
camilla.sandberg@medicin.umu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bengt Johansson, MD, Phd
Organizational Affiliation
Umea University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skåne University hospital
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Individual Site Status
Completed
Facility Name
University Hospital
City
Umeå
ZIP/Postal Code
90185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bengt Johansson, MD, PhD
Phone
+46907852782
Email
bengt.johansson@medicin.umu.se
First Name & Middle Initial & Last Name & Degree
Camilla Sandberg, RPT, PhD
Phone
+46907858441
Email
camilla.sandberg@medicin.umu.se
First Name & Middle Initial & Last Name & Degree
Bengt Johansson, MD, PhD
First Name & Middle Initial & Last Name & Degree
Camilla Sandberg Sandberg, RPT, PhD
Facility Name
University Hospital Uppsala
City
Uppsala
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Christersson, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25038081
Citation
Sandberg C, Thilen U, Wadell K, Johansson B. Adults with complex congenital heart disease have impaired skeletal muscle function and reduced confidence in performing exercise training. Eur J Prev Cardiol. 2015 Dec;22(12):1523-30. doi: 10.1177/2047487314543076. Epub 2014 Jul 18.
Results Reference
background
PubMed Identifier
23846614
Citation
Cordina R, O'Meagher S, Gould H, Rae C, Kemp G, Pasco JA, Celermajer DS, Singh N. Skeletal muscle abnormalities and exercise capacity in adults with a Fontan circulation. Heart. 2013 Oct;99(20):1530-4. doi: 10.1136/heartjnl-2013-304249. Epub 2013 Jul 11. Erratum In: Heart. 2013 Dec;99(23):1788. Singh, Nalin [added].
Results Reference
background
PubMed Identifier
24295897
Citation
Kroonstrom LA, Johansson L, Zetterstrom AK, Dellborg M, Eriksson P, Cider A. Muscle function in adults with congenital heart disease. Int J Cardiol. 2014 Jan 1;170(3):358-63. doi: 10.1016/j.ijcard.2013.11.014. Epub 2013 Nov 13.
Results Reference
background
PubMed Identifier
25838217
Citation
Sandberg C, Rinnstrom D, Dellborg M, Thilen U, Sorensson P, Nielsen NE, Christersson C, Wadell K, Johansson B. Height, weight and body mass index in adults with congenital heart disease. Int J Cardiol. 2015;187:219-26. doi: 10.1016/j.ijcard.2015.03.153. Epub 2015 Mar 18.
Results Reference
background
PubMed Identifier
33112424
Citation
Williams CA, Wadey C, Pieles G, Stuart G, Taylor RS, Long L. Physical activity interventions for people with congenital heart disease. Cochrane Database Syst Rev. 2020 Oct 28;10(10):CD013400. doi: 10.1002/14651858.CD013400.pub2.
Results Reference
derived

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Effect of Resistance Training in Adults With Complex Congenital Heart Disease

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