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

• ClinicalTrials.gov Identifier: NCT00708136
• Recruitment Status: Completed
• First Posted: July 2, 2008
• Last Update Posted: July 2, 2008
• Sponsor: Soroka University Medical Center
• Information provided by: Soroka University Medical Center

Study Description

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

Study Design

• 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

Arms and Interventions

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Israel

SorokaUMC

Beer-Sheva, Israel, 84105

Sponsors and Collaborators

Soroka University Medical Center

Investigators

• 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: itshak Melzer, Ben-gurion Univesity
• ClinicalTrials.gov Identifier: NCT00708136
• Other Study ID Numbers: sor404605ctil; ISRCTN4046
• First Posted: July 2, 2008
• 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