Effect of Water-Exercise on Balance Function of Healthy Elderly Individuals

Balance Clinical Trial

— EWEB  

Official title:

Effect of Water-Exercise on Balance Function of Healthy Elderly Individuals - A Randomized Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00708136
• Other study ID #: sor404605ctil
• Secondary ID: ISRCTN4046
• Status: Completed
• Phase: N/A
• First received: June 29, 2008
• Last updated: July 1, 2008
• Start date: January 2006
• Est. completion date: June 2007

Study information

• Verified date: November 2005
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Balance
• Stability

Intervention

Behavioral:
• water based training program to improve balance

Locations

Country	Name	City	State
Israel	SorokaUMC	Beer-Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg Balance Scale		before and 3 months after Training	No
Primary	Late life Function and Disability Instrument		before and after the training	No
Primary	Get up and go test		before and after 3 month of training	No
Primary	Step execution test under single and dual task		before and 3 months after Training	No
Primary	Stability tests		before and 3 months after Training	No