Effect of Resistance Training in Adults With Complex Congenital Heart Disease

NCT02658266 | Unknown

• 1 other identifier: GUCHUmU02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Congenital Heart Defect

Keywords

resistance training; adult; muscle strength; muscle endurance; muscle metabolism

Outcome Measures

Primary Outcomes (1)

• Change in muscle strength (Newton, N)

  Change from baseline muscle strength at 12 weeks follow-up

Secondary Outcomes (6)

• 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

• Change in appendicular skeletal muscle mass (kg)

  Change from baseline appendicular skeletal muscle mass at 12 weeks follow-up

• Change in body fat percentage

  Change from baseline body fat percentage at 12 weeks follow-up

• Change in bone mineral density (g/cm2)

  Change from baseline bone mineral density at 12 weeks follow-up

Other Outcomes (2)

• Compliance to study protocol

  At completion of study protocol 12 weeks

• Adverse events

  Once a week from the date of onset of the home based exercise regimen until the followup at 12 weeks

Study Arms (2)

Resistance training

EXPERIMENTAL

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

Behavioral: Home based resistance training

Control group

NO INTERVENTION

No instructed exercise training. Continue with habitual physical activity.

Interventions

Home based resistance training BEHAVIORAL

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.

Resistance training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umeå University: lead

Study Sites (3)

Skåne University hospital

Lund, 22185, Sweden

COMPLETED

University Hospital

Umeå, 90185, Sweden

RECRUITING

University Hospital Uppsala

Uppsala, Sweden

RECRUITING

Related Publications (5)

• 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.

  PMID: 25038081 BACKGROUND

• 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.

  PMID: 23846614 BACKGROUND

• 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.

  PMID: 24295897 BACKGROUND

• 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.

  PMID: 25838217 BACKGROUND

• 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.

  PMID: 33112424 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Bengt Johansson, MD, Phd

  Umea University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bengt Johansson, MD, PhD

CONTACT

+46907852782; bengt.johansson@medicin.umu.se

Camilla Sandberg, PhD stud

CONTACT

+46907858441; camilla.sandberg@medicin.umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 18, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2019
• Last Updated: September 14, 2017

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)