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- Essai clinique NCT02658266
Effect of Resistance Training in Adults With Complex Congenital Heart Disease
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Bengt Johansson, MD, PhD
- Numéro de téléphone: +46907852782
- E-mail: bengt.johansson@medicin.umu.se
Sauvegarde des contacts de l'étude
- Nom: Camilla Sandberg, PhD stud
- Numéro de téléphone: +46907858441
- E-mail: camilla.sandberg@medicin.umu.se
Lieux d'étude
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Lund, Suède, 22185
- Complété
- Skane University Hospital
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Umeå, Suède, 90185
- Recrutement
- University Hospital
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Contact:
- Bengt Johansson, MD, PhD
- Numéro de téléphone: +46907852782
- E-mail: bengt.johansson@medicin.umu.se
-
Contact:
- Camilla Sandberg, RPT, PhD
- Numéro de téléphone: +46907858441
- E-mail: camilla.sandberg@medicin.umu.se
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Chercheur principal:
- Bengt Johansson, MD, PhD
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Sous-enquêteur:
- Camilla Sandberg Sandberg, RPT, PhD
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Uppsala, Suède
- Recrutement
- University Hospital Uppsala
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Contact:
- Christina Christersson, MD, Phd
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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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Aucune intervention: Control group
No instructed exercise training.
Continue with habitual physical activity.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Change in muscle strength (Newton, N)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in muscle endurance (number of repetitions)
Délai: Change from baseline muscle endurance at 12 weeks follow-up
|
Change from baseline muscle endurance at 12 weeks follow-up
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|
Change in total body skeletal muscle mass (kg)
Délai: 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)
Délai: 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
Délai: Change from baseline body fat percentage at 12 weeks follow-up
|
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)
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Compliance to study protocol
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Bengt Johansson, MD, Phd, Umea University
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GUCHUmU02
Plan pour les données individuelles des participants (IPD)
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