- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02658266
Effect of Resistance Training in Adults With Complex Congenital Heart Disease
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Bengt Johansson, MD, PhD
- Numero di telefono: +46907852782
- Email: bengt.johansson@medicin.umu.se
Backup dei contatti dello studio
- Nome: Camilla Sandberg, PhD stud
- Numero di telefono: +46907858441
- Email: camilla.sandberg@medicin.umu.se
Luoghi di studio
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Lund, Svezia, 22185
- Completato
- Skane University Hospital
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Umeå, Svezia, 90185
- Reclutamento
- University Hospital
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Contatto:
- Bengt Johansson, MD, PhD
- Numero di telefono: +46907852782
- Email: bengt.johansson@medicin.umu.se
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Contatto:
- Camilla Sandberg, RPT, PhD
- Numero di telefono: +46907858441
- Email: camilla.sandberg@medicin.umu.se
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Investigatore principale:
- Bengt Johansson, MD, PhD
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Sub-investigatore:
- Camilla Sandberg Sandberg, RPT, PhD
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Uppsala, Svezia
- Reclutamento
- University Hospital Uppsala
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Contatto:
- Christina Christersson, MD, Phd
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Resistance training
Home based resistance training 12 weeks home based resistance training 3 times per week, 10-12 reps, 2 sets
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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.
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Nessun intervento: Control group
No instructed exercise training.
Continue with habitual physical activity.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Change in muscle strength (Newton, N)
Lasso di tempo: Change from baseline muscle strength at 12 weeks follow-up
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Change from baseline muscle strength at 12 weeks follow-up
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in muscle endurance (number of repetitions)
Lasso di tempo: Change from baseline muscle endurance at 12 weeks follow-up
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Change from baseline muscle endurance at 12 weeks follow-up
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Change in total body skeletal muscle mass (kg)
Lasso di tempo: Change from baseline total body skeletal muscle mass at 12 weeks follow-up
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Using dual-energy x-ray absorptiometry (DEXA)
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Change from baseline total body skeletal muscle mass at 12 weeks follow-up
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Change in appendicular skeletal muscle mass (kg)
Lasso di tempo: Change from baseline appendicular skeletal muscle mass at 12 weeks follow-up
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Using dual-energy x-ray absorptiometry (DEXA)
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Change from baseline appendicular skeletal muscle mass at 12 weeks follow-up
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Change in body fat percentage
Lasso di tempo: Change from baseline body fat percentage at 12 weeks follow-up
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Using dual-energy x-ray absorptiometry (DEXA)
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Change from baseline body fat percentage at 12 weeks follow-up
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Change in bone mineral density (g/cm2)
Lasso di tempo: Change from baseline bone mineral density at 12 weeks follow-up
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Using dual-energy x-ray absorptiometry (DEXA)
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Change from baseline bone mineral density at 12 weeks follow-up
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Muscle metabolism
Lasso di tempo: Change from baseline muscle metabolism at 12 weeks follow-up
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near infrared spectroscopy (NIRS)
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Change from baseline muscle metabolism at 12 weeks follow-up
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Compliance to study protocol
Lasso di tempo: At completion of study protocol 12 weeks
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number of training sessions
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At completion of study protocol 12 weeks
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Adverse events
Lasso di tempo: Once a week from the date of onset of the home based exercise regimen until the followup at 12 weeks
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Complications to resistance training
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Once a week from the date of onset of the home based exercise regimen until the followup at 12 weeks
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Bengt Johansson, MD, Phd, Umea University
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Maggiori informazioni
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Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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