- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Beer-Sheva, Israël, 84105
- SorokaUMC
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Berg Balance Scale
Délai: before and 3 months after Training
|
before and 3 months after Training
|
|
Late life Function and Disability Instrument
Délai: before and after the training
|
before and after the training
|
|
Get up and go test
Délai: before and after 3 month of training
|
before and after 3 month of training
|
|
Step execution test under single and dual task
Délai: before and 3 months after Training
|
before and 3 months after Training
|
|
Stability tests
Délai: before and 3 months after Training
|
before and 3 months after Training
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: dagan Shvartz, MD, Ben-Gurion University of the Negev
Publications et liens utiles
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
Autres numéros d'identification d'étude
- sor404605ctil
- ISRCTN4046
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