Effect of Resistance Training in Adults With Complex Congenital Heart Disease

Congenital Heart Defect Clinical Trial

Official title:

Effect of Resistance Training in Adults With Complex Congenital Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02658266
• Other study ID #: GUCHUmU02
• Status: Recruiting
• Phase: N/A
• First received: January 11, 2016
• Last updated: September 13, 2017
• Start date: February 2016
• Est. completion date: February 2019

Study information

• Verified date: August 2016
• Source: Umeå University
• Contact: Bengt Johansson, MD, PhD
• Phone: +46907852782
• Email: bengt.johansson[@]medicin.umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2019
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Defect
• Heart Defects, Congenital
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
Sweden	Skåne University hospital	Lund
Sweden	University Hospital	Umeå
Sweden	University Hospital Uppsala	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

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]. — View Citation

Kröönström LA, Johansson L, Zetterström AK, Dellborg M, Eriksson P, Cider Å. 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. — View Citation

Sandberg C, Rinnström D, Dellborg M, Thilén U, Sörensson 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. — View Citation

Sandberg C, Thilén 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance to study protocol	number of training sessions	At completion of study protocol 12 weeks
Other	Adverse events	Complications to resistance training	Once a week from the date of onset of the home based exercise regimen until the followup at 12 weeks
Primary	Change in muscle strength (Newton, N)		Change from baseline muscle strength at 12 weeks follow-up
Secondary	Change in muscle endurance (number of repetitions)		Change from baseline muscle endurance at 12 weeks follow-up
Secondary	Change in total body skeletal muscle mass (kg)	Using dual-energy x-ray absorptiometry (DEXA)	Change from baseline total body skeletal muscle mass at 12 weeks follow-up
Secondary	Change in appendicular skeletal muscle mass (kg)	Using dual-energy x-ray absorptiometry (DEXA)	Change from baseline appendicular skeletal muscle mass at 12 weeks follow-up
Secondary	Change in body fat percentage	Using dual-energy x-ray absorptiometry (DEXA)	Change from baseline body fat percentage at 12 weeks follow-up
Secondary	Change in bone mineral density (g/cm2)	Using dual-energy x-ray absorptiometry (DEXA)	Change from baseline bone mineral density at 12 weeks follow-up
Secondary	Muscle metabolism	near infrared spectroscopy (NIRS)	Change from baseline muscle metabolism at 12 weeks follow-up