- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 5B2
- College of Kinesiology
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Placebo-vergelijker: Controle
|
no exercise
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Experimenteel: Aquatic Education
Exercise combined with education
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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.
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Experimenteel: Aquatic
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A community aquatic exercise program designed for older adults to improve balance, strength and mobility to decrease the risk of falls.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change in Balance
Tijdsspanne: 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
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Change in Chair Stands
Tijdsspanne: 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
Tijdsspanne: baseline and 11 weeks
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change in 6 minute walk (distance in meters covered in 6 minutes)over 11 weeks
|
baseline and 11 weeks
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Change in Falls-Efficacy
Tijdsspanne: baseline and 11 weeks
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change in Activities Balance Confidence Scale (0 - 100, 100 represents high confidence, 0 represents low confidence)
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baseline and 11 weeks
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Change in Dual Task Function
Tijdsspanne: baseline and 11 weeks
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change in Timed Up and Go Cognitive Test (time in sec., lower number means better performance)
|
baseline and 11 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change in Physical Activity
Tijdsspanne: baseline and 11 weeks
|
change in Physical Activity Scale for the Elderly (0 - up to 300, higher score more active)
|
baseline and 11 weeks
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Cathy M Arnold, MSc, University of Saskatchewan
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- BIO-REB 05-158
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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