- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00289458
Aquatic Exercise and Efficacy Enhancement to Decrease Fall Risk in Older Adults With Hip Osteoarthritis
The Effect of Aquatic Exercise and Aquatic Exercise Combined With Education and Efficacy Enhancement on Improving Indices of Fall Risk in Older Adults With Hip Osteoarthritis: a Randomized Controlled Clinical Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Older adults with hip osteoarthritis (OA) often experience pain and loss of mobility that significantly impairs their ability to walk, climb stairs, shop or participate in exercise programs. This can result in social isolation, depression and loss of confidence in their ability to manage independently in the community. A decline in physical and psycho-social function leads to increased risk of falling. It is crucial to identify high-risk fallers as well as the best interventions to decrease that risk; hip fractures from falls are devastating, resulting in death or admission to long-term care for the majority who sustain them.
Exercise programs designed to improve balance, strength and mobility can help to improve function and decrease risk of falling. However, individuals with hip OA may have difficulty participating in these programs due to pain. Aquatic exercise offers an activity alternative to improve mobility, strength and decrease fall risk. As well, the addition of a group program designed to enhance confidence in movement may further reduce the risk of falls by improving independence to be more active at home and in the community.
This project will evaluate the effect of aquatic exercise and aquatic exercise combined with a group educational program on decreasing fall risk in older adults with hip OA. Determining optimal fall prevention programs may avert death and loss of quality of life for older adults, clearly an important contribution to preventative health care.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada, S7N 5B2
- College of Kinesiology
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- over age 65
- clinical diagnosis of hip osteoarthritis
Exclusion Criteria:
- medical condition tha significantly decreases functional ability such that not safe to exercise in a community program
- already exercising in a moderate exercise program 2/week or more
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 |
---|---|
Comparateur placebo: Contrôler
|
no exercise
|
Expérimental: Aquatic Education
Exercise combined with education
|
Same as 1 with the addition of a 1/week educational group program to improve confidence in movement, learn about fall risk and fall prevention and the rationale for the exercises to decrease fall risk.
|
Expérimental: Aquatic
|
A community aquatic exercise program designed for older adults to improve balance, strength and mobility to decrease the risk of falls.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in Balance
Délai: baseline and 11 weeks
|
Berg Balance Scale range 0 - 36 (36 is excellent balance, 0 is poor or no ability for standing balance)
|
baseline and 11 weeks
|
Change in Chair Stands
Délai: baseline and 11 weeks
|
change in number of repetitions (the number of times moving from full sitting to full standing in 30 seconds)
|
baseline and 11 weeks
|
Change in Walking
Délai: baseline and 11 weeks
|
change in 6 minute walk (distance in meters covered in 6 minutes)over 11 weeks
|
baseline and 11 weeks
|
Change in Falls-Efficacy
Délai: baseline and 11 weeks
|
change in Activities Balance Confidence Scale (0 - 100, 100 represents high confidence, 0 represents low confidence)
|
baseline and 11 weeks
|
Change in Dual Task Function
Délai: baseline and 11 weeks
|
change in Timed Up and Go Cognitive Test (time in sec., lower number means better performance)
|
baseline and 11 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in Physical Activity
Délai: baseline and 11 weeks
|
change in Physical Activity Scale for the Elderly (0 - up to 300, higher score more active)
|
baseline and 11 weeks
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Cathy M Arnold, MSc, University of Saskatchewan
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
- BIO-REB 05-158
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 .
Essais cliniques sur 2
-
University College, LondonMoorfields Eye Hospital NHS Foundation Trust; Targeted Genetics CorporationComplétéDégénérescence rétinienneRoyaume-Uni
-
Medifast, Inc.Complété
-
University of Sao Paulo General HospitalComplétéSyndrome de la vessie hyperactiveBrésil
-
University of PennsylvaniaNational Cancer Institute (NCI); PfizerComplété
-
Hanmi Pharmaceutical Company LimitedComplétéHypertensionCorée, République de
-
Metabolic Technologies Inc.National Institute on Aging (NIA); Vanderbilt UniversityComplété
-
Metabolic Technologies Inc.National Institute on Aging (NIA); Vanderbilt UniversityComplété
-
Sanofi Pasteur, a Sanofi CompanyImmune DesignRésilié
-
Vanderbilt University Medical CenterAmerican Heart AssociationActif, ne recrute pasFibrillation auriculaireÉtats-Unis
-
Children's Hospital Medical Center, CincinnatiNationwide Children's Hospital; University of Cincinnati; Connecticut Children... et autres collaborateursRecrutementMaladies intestinales inflammatoires | Maladie de Crohn | Rectocolite hémorragiqueÉtats-Unis