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Effect of Water-Exercise on Balance Function of Healthy Elderly Individuals (EWEB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00708136
Recruitment Status : Completed
First Posted : July 2, 2008
Last Update Posted : July 2, 2008
Sponsor:
Information provided by:
Soroka University Medical Center

Brief Summary:

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:

  1. able to stand independently 90 seconds
  2. able to walk 10 meters (with cane if necessary)
  3. able to understand verbal instructions.

The exclusion criteria will be:

  1. Serious visual impairment
  2. Inability to ambulate independently (cane acceptable, walker not).
  3. Severely impaired cognitive status (score less then 24 in Mini Mental State Examination).
  4. 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

  1. Medical background variables.
  2. Berg Balance Scale.
  3. Late life Function and Disability Instrument.
  4. Get up and go test - stand up and walk 3 meters turn around and walk back to the chair.
  5. Fall Efficacy Scale
  6. Fall incidence and fall severity.
  7. 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.


Condition or disease Intervention/treatment Phase
Stability Balance Behavioral: water based training program to improve balance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Water-Exercise on Balance Function of Healthy Elderly Individuals - A Randomized Control Study
Study Start Date : January 2006
Actual Primary Completion Date : January 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Berg Balance Scale [ Time Frame: before and 3 months after Training ]
  2. Late life Function and Disability Instrument [ Time Frame: before and after the training ]
  3. Get up and go test [ Time Frame: before and after 3 month of training ]
  4. Step execution test under single and dual task [ Time Frame: before and 3 months after Training ]
  5. Stability tests [ Time Frame: before and 3 months after Training ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. able to stand independently 90 seconds;
  2. able to walk 10 meters (with cane if necessary);
  3. able to understand verbal instructions.

Exclusion Criteria:

  1. Serious visual impairment;
  2. Inability to ambulate independently (cane acceptable, walker not).
  3. Severely impaired cognitive status (score less then 24 in Mini Mental State Examination).
  4. Persons with impaired communication capabilities.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00708136


Locations
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Israel
SorokaUMC
Beer-Sheva, Israel, 84105
Sponsors and Collaborators
Soroka University Medical Center
Investigators
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Principal Investigator: Itshak Melzer, PhD Ben-gurion University of the Negev, Beer-Sheva, Israel
Study Chair: dagan Shvartz, MD Ben-Gurion University of the Negev

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: itshak Melzer, Ben-gurion Univesity
ClinicalTrials.gov Identifier: NCT00708136    
Other Study ID Numbers: sor404605ctil
ISRCTN4046
First Posted: July 2, 2008    Key Record Dates
Last Update Posted: July 2, 2008
Last Verified: November 2005
Keywords provided by Soroka University Medical Center:
Falls
elderly
Balance
speed of stepping
Stability
ELDERLY FALLERS