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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

Tracking Information
First Submitted Date  ICMJE June 29, 2008
First Posted Date  ICMJE July 2, 2008
Last Update Posted Date July 2, 2008
Study Start Date  ICMJE January 2006
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2008)
  • Berg Balance Scale [ Time Frame: before and 3 months after Training ]
  • Late life Function and Disability Instrument [ Time Frame: before and after the training ]
  • Get up and go test [ Time Frame: before and after 3 month of training ]
  • Step execution test under single and dual task [ Time Frame: before and 3 months after Training ]
  • Stability tests [ Time Frame: before and 3 months after Training ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Water-Exercise on Balance Function of Healthy Elderly Individuals
Official Title  ICMJE Effect of Water-Exercise on Balance Function of Healthy Elderly Individuals - A Randomized Control Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Stability
  • Balance
Intervention  ICMJE Behavioral: water based training program to improve balance
Study Arms  ICMJE Not Provided
Publications * Melzer I, Elbar O, Tsedek I, Oddsson LIe. A water-based training program that include perturbation exercises to improve stepping responses in older adults: study protocol for a randomized controlled cross-over trial. BMC Geriatr. 2008 Aug 17;8:19. doi: 10.1186/1471-2318-8-19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2008)
37
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00708136
Other Study ID Numbers  ICMJE sor404605ctil
ISRCTN4046
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party itshak Melzer, Ben-gurion Univesity
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Soroka University Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Soroka University Medical Center
Verification Date November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP