Effect of Resistance Training in Adults With Complex Congenital Heart Disease
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Lund, Sverige, 22185
- Fullført
- Skane University Hospital
-
Umeå, Sverige, 90185
- Rekruttering
- University Hospital
-
Ta kontakt med:
- Bengt Johansson, MD, PhD
- Telefonnummer: +46907852782
- E-post: bengt.johansson@medicin.umu.se
-
Ta kontakt med:
- Camilla Sandberg, RPT, PhD
- Telefonnummer: +46907858441
- E-post: camilla.sandberg@medicin.umu.se
-
Hovedetterforsker:
- Bengt Johansson, MD, PhD
-
Underetterforsker:
- Camilla Sandberg Sandberg, RPT, PhD
-
Uppsala, Sverige
- Rekruttering
- University hospital Uppsala
-
Ta kontakt med:
- Christina Christersson, MD, Phd
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Resistance training
Home based resistance training 12 weeks home based resistance training 3 times per week, 10-12 reps, 2 sets
|
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.
|
|
Ingen inngripen: Control group
No instructed exercise training.
Continue with habitual physical activity.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in muscle strength (Newton, N)
Tidsramme: Change from baseline muscle strength at 12 weeks follow-up
|
Change from baseline muscle strength at 12 weeks follow-up
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in muscle endurance (number of repetitions)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Change from baseline muscle metabolism at 12 weeks follow-up
|
near infrared spectroscopy (NIRS)
|
Change from baseline muscle metabolism at 12 weeks follow-up
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Compliance to study protocol
Tidsramme: At completion of study protocol 12 weeks
|
number of training sessions
|
At completion of study protocol 12 weeks
|
|
Adverse events
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Bengt Johansson, MD, Phd, Umeå University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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].
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GUCHUmU02
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .