- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01367197
Study of the Effect of Exercise Training on Patients in Atrial Fibrillation
Randomised Study of the Effect of Exercise Training on Patients in Atrial Fibrillation
PURPOSE Physical exercise is beneficial for patients with ischemic heart disease and chronic heart failure, while little is known about the effect in atrial fibrillation (AF). The investigators studied the effect of physical exercise on cardiac output (CO), max. exercise capacity, biomarkers and quality of life (Qol) in patients with AF in a randomised study of physical exercise training three times weekly for twelve weeks.
HYPOTHESIS Exercise training improves cardiac output (CO), max. exercise capacity, biomarkers and quality of life (Qol) in patients with AF.
METHODS Assessment of exercise capacity, CO, Qol, body composition, six minute walk test and muscular strength was performed before and after 12 weeks.
Resting echocardiography was done at baseline. CO was measured using impedance cardiography at rest and during maximal exercise testing on an ergometer bicycle. Body composition, muscular strength and six minutes walking capacity were measured before and after the training period. Qol was evaluated by the use of the standardized validated questionnaires Short Form 36 (SF-36) and the Minnesota Living with Heart Failure Questionnaire (MLHF-Q).
Training consisted of aerobic exercise at 70 percent of max. capacity estimated by Borg-scale.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Hvidovre
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Copenhagen, Hvidovre, Danemark, 2650
- Hvidovre Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Adult subjects in permanent atrial fibrillation, willing to participate in a 12 weeks training program and able to give informed consent to participation were eligible for the study.
Exclusion Criteria:
- Subjects with severe refractory hypertension
- previous heart valve surgery, moderate to severe COPD
- restrictive lung disease, moderate to severe asthma
- pregnant or lactating subjects
- patients with a very low life expectancy
- patients who were unable to exercise or comply with the study protocol
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Aucune intervention: No intervention
Observation only
|
|
Expérimental: Exercise training group
Group exercise training, three times weekly high-intensity
|
group based exercise training
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
cardiac output
Délai: participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
Quality of life
Délai: participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
exercise capacity
Délai: participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
muscle strength
Délai: participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
biomarkers ANB, BNP
Délai: participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
Body composition DEXA-scan
Délai: participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
participants will be followed for the duration of the intervention, an average of 12 weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Philip S Osbak, MD, Hvidovre University Hospital
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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 (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 22300240
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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