- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
Saskatchewan
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Saskatoon, Saskatchewan, Kanada, S7N 5B2
- College of Kinesiology
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Placebo-Komparator: Kontrolle
|
no exercise
|
Experimental: 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.
|
Experimental: Aquatic
|
A community aquatic exercise program designed for older adults to improve balance, strength and mobility to decrease the risk of falls.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in Balance
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: baseline and 11 weeks
|
change in Timed Up and Go Cognitive Test (time in sec., lower number means better performance)
|
baseline and 11 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in Physical Activity
Zeitfenster: baseline and 11 weeks
|
change in Physical Activity Scale for the Elderly (0 - up to 300, higher score more active)
|
baseline and 11 weeks
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Cathy M Arnold, MSc, University of Saskatchewan
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- BIO-REB 05-158
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