- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00708136
Effect of Water-Exercise on Balance Function of Healthy Elderly Individuals (EWEB)
Effect of Water-Exercise on Balance Function of Healthy Elderly Individuals - A Randomized Control Study
The proposed project is a Randomized Controlled study design. Seniors (age >65) willing to participate in the study will be shortly interviewed to assess eligibility according to the inclusion-exclusion criteria. The first 60 subjects who upon questioning were judged to meet the following inclusion criteria:
- able to stand independently 90 seconds
- able to walk 10 meters (with cane if necessary)
- able to understand verbal instructions.
The exclusion criteria will be:
- Serious visual impairment
- Inability to ambulate independently (cane acceptable, walker not).
- Severely impaired cognitive status (score less then 24 in Mini Mental State Examination).
- Persons with impaired communication capabilities.
The whole project will be conducted over a period of 24 months. The proposed study is a randomized experimental intervention/ control group design. A total of 60 elderly volunteer subjects will be randomly assigned to two groups, exercise group (30) and control group (30). Twelve training periods will be performed with 8 subjects participating in training during each period (4 exercise groups). The exercise group will meet on 24 occasions over a period of 12 weeks (2 times/week).
Gait and balance function will be tested in both groups with well established measuring techniques before and after the training period. The measuring techniques
- Medical background variables.
- Berg Balance Scale.
- Late life Function and Disability Instrument.
- Get up and go test - stand up and walk 3 meters turn around and walk back to the chair.
- Fall Efficacy Scale
- Fall incidence and fall severity.
- 6-minute walk test. The control group will not perform any specific balance training during the 12 week period.
These individuals from control will participate in a separate exercise program after the training period.
The water training intervention is performed on different levels where each level reflects different increasing demands on the postural control system. The water exercises also include perturbation exercises that trigger specific reflex-like balance responses. On each level the instructor can instantly modify an exercise to be more or less challenging for each participant.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Beer-Sheva, Israel, 84105
- SorokaUMC
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- able to stand independently 90 seconds;
- able to walk 10 meters (with cane if necessary);
- able to understand verbal instructions.
Exclusion Criteria:
- Serious visual impairment;
- Inability to ambulate independently (cane acceptable, walker not).
- Severely impaired cognitive status (score less then 24 in Mini Mental State Examination).
- Persons with impaired communication capabilities.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Berg Balance Scale
Tidsramme: before and 3 months after Training
|
before and 3 months after Training
|
|
Late life Function and Disability Instrument
Tidsramme: before and after the training
|
before and after the training
|
|
Get up and go test
Tidsramme: before and after 3 month of training
|
before and after 3 month of training
|
|
Step execution test under single and dual task
Tidsramme: before and 3 months after Training
|
before and 3 months after Training
|
|
Stability tests
Tidsramme: before and 3 months after Training
|
before and 3 months after Training
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: dagan Shvartz, MD, Ben-Gurion University of the Negev
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- sor404605ctil
- ISRCTN4046
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