- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada, S7N 5B2
- College of Kinesiology
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: Styring
|
no exercise
|
Eksperimentel: 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.
|
Eksperimentel: Aquatic
|
A community aquatic exercise program designed for older adults to improve balance, strength and mobility to decrease the risk of falls.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in Balance
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: baseline and 11 weeks
|
change in Timed Up and Go Cognitive Test (time in sec., lower number means better performance)
|
baseline and 11 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in Physical Activity
Tidsramme: baseline and 11 weeks
|
change in Physical Activity Scale for the Elderly (0 - up to 300, higher score more active)
|
baseline and 11 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Cathy M Arnold, MSc, University of Saskatchewan
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BIO-REB 05-158
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Gigt
-
University of AarhusAarhus University HospitalAfsluttetPolyartikulær juvenil reumatoid arthritis | Systemisk juvenil idiopatisk arthritis | Juvenil Idiopatisk Arthritis, OligoarthritisDanmark
-
University of Sao Paulo General HospitalIkke rekrutterer endnuJuvenil idiopatisk arthritis | Juvenil reumatoid arthritis | Juvenil arthritisBrasilien
-
Sunnybrook Health Sciences CentreUniversity Health Network, Toronto; University of TorontoAfsluttet
-
DePuy OrthopaedicsAfsluttetSlidgigt | Rheumatoid arthritis | Avaskulær nekrose | Juvenil reumatoid arthritis | Post-traumatisk arthritis | Anden inflammatorisk arthritisForenede Stater
-
Biomet Orthopedics, LLCNew Lexington ClinicAfsluttetSlidgigt | Rheumatoid arthritis | Knæ arthritis | Degenerativ arthritisForenede Stater
-
Biomet Orthopedics, LLCNew Lexington ClinicAfsluttetSlidgigt | Rheumatoid arthritis | Knæ arthritis | Degenerativ arthritisForenede Stater
-
NovartisAfsluttetArthritis, Juvenil ReumatoidItalien
-
Centocor, Inc.Afsluttet
-
GeneScience Pharmaceuticals Co., Ltd.Ikke rekrutterer endnuAktiv systemisk juvenil idiopatisk arthritisKina
-
Institut National de la Santé Et de la Recherche...AfsluttetSystemisk opstået juvenil idiopatisk arthritisFrankrig
Kliniske forsøg med 2
-
University College, LondonMoorfields Eye Hospital NHS Foundation Trust; Targeted Genetics CorporationAfsluttetNethindedegenerationDet Forenede Kongerige
-
Medifast, Inc.Afsluttet
-
University of PennsylvaniaNational Cancer Institute (NCI); PfizerAfsluttet
-
Metabolic Technologies Inc.National Institute on Aging (NIA); Vanderbilt UniversityAfsluttet
-
Metabolic Technologies Inc.National Institute on Aging (NIA); Vanderbilt UniversityAfsluttet
-
University of Sao Paulo General HospitalAfsluttetOveraktiv blæresyndromBrasilien
-
Sanofi Pasteur, a Sanofi CompanyImmune DesignAfsluttet
-
Hanmi Pharmaceutical Company LimitedAfsluttetForhøjet blodtrykKorea, Republikken
-
Vanderbilt University Medical CenterAmerican Heart AssociationAktiv, ikke rekrutterendeAtrieflimrenForenede Stater
-
Children's Hospital Medical Center, CincinnatiNationwide Children's Hospital; University of Cincinnati; Connecticut Children... og andre samarbejdspartnereRekrutteringInflammatoriske tarmsygdomme | Crohns sygdom | Colitis ulcerosaForenede Stater