- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02100020
Implementing Physical Activity Guidelines for Adults With MS
A Community-based Randomized Controlled Trial Testing Implementation of the New Canadian Physical Activity Guidelines for Adults With Multiple Sclerosis.
The proposed project will evaluate two methods of implementation of the new Physical Activity Guidelines (PAGs) for Adults with Multiple Sclerosis (MS) living in two Ontario communities. The investigators will also determine if following the PAGs will improve aspects of fitness, function, quality of life and risk for cardiometabolic disease in this population. The investigators hypothesize that adherence to the PAGs will be higher in people who have been referred directly to a community-based exercise program, and that this greater adherence to physical activity will be associated with greater improvements in fitness, function and quality of life.
This randomized controlled trial will provide important information on how best to implement physical activity recommendations within the community setting; this information will be translated to key stakeholders during the final stages of the project.
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
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Ontario
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Hamilton, Ontario, Canada, L8S 4K1
- McMaster University, Physical Activity Centre for Excellence
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Kingston, Ontario, Canada, K7L 3N6
- Queens University
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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:
- Diagnosis of MS with mild-moderate disability (EDSS 1-7)
- Aged 18-60
- Medical clearance to participate in physical activity
Exclusion Criteria:
- current participation in regular physical activity (at least twice-weekly)
- other serious medical condition that might impair ability to participate in strength or aerobic exercise
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Direct Referral to Physical Activity
The REF group will be referred to a centre-based community exercise program in their respective community (either the MacWheelers or Revved Up) by a clinical neurologist where they will be prescribed exercise based on the PAGs for adults with MS, and according to their individual capabilities.
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Participants randomized to the Direct Referral to Physical Activity Arm will be provided with a referral to a physical activity program in their community and will be closely monitored in this program for 16 wks.
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Aucune intervention: Control
The CON group will be provided with a print copy of the PAGs and a link to an online resource for physical activity information.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Adherence to the Physical Activity Guidelines
Délai: 3 years
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Adherence to the physical activity guidelines will be analyzed by having participants fill in a weekly physical activity log that will be sent to them by email.
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3 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Physical Fitness
Délai: At baseline and after the 16 week intervention
|
Peak oxygen uptake, maximum muscle strength, bodyweight
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At baseline and after the 16 week intervention
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Perceived Quality of Life
Délai: At baseline and after the 16 week intervention
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Multiple Sclerosis Quality of Life (MSQoL) scale
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At baseline and after the 16 week intervention
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Fatigue
Délai: At baseline and after the 16 week intervention
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Multiple Sclerosis Fatigue Impact Scale (MSFIS)
|
At baseline and after the 16 week intervention
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Mobility
Délai: At baseline and after the 16 week intervention
|
25ft walk test
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At baseline and after the 16 week intervention
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Blood markers of cardiovascular disease risk
Délai: At baseline and after the 16 week intervention
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blood lipid panel, HbA1c, fasting glucose
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At baseline and after the 16 week intervention
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Audrey L Hicks, Ph.D., McMaster University
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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 (Réel)
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
- MSProject2001
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