Clinical trial NCT00708136: Effect of Water-Exercise on Balance Function of Healthy Elderly Individuals
Official title: Effect of Water-Exercise on Balance Function of Healthy Elderly Individuals - A Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stability
Balance
Keywords: Falls
elderly
Balance
speed of stepping
Stability
ELDERLY FALLERS
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2008-07-02
Enrollment: 37
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Berg Balance Scale
timeFrame: before and 3 months after Training
measure: Late life Function and Disability Instrument
timeFrame: before and after the training
measure: Get up and go test
timeFrame: before and after 3 month of training
measure: Step execution test under single and dual task
timeFrame: before and 3 months after Training
measure: Stability tests
timeFrame: before and 3 months after Training
Secondary outcomes:
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: SorokaUMC
Study officials:
affiliation: Ben-gurion University of the Negev, Beer-Sheva, Israel
name: Itshak Melzer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ben-Gurion University of the Negev
name: dagan Shvartz, MD
role: STUDY_CHAIR
References:
citation: 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.