NCT00708136

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. 1.able to stand independently 90 seconds
  2. 2.able to walk 10 meters (with cane if necessary)
  3. 3.able to understand verbal instructions.
  4. 4.Serious visual impairment
  5. 5.Inability to ambulate independently (cane acceptable, walker not).
  6. 6.Severely impaired cognitive status (score less then 24 in Mini Mental State Examination).
  7. 7.Persons with impaired communication capabilities.
  8. 8.Medical background variables.
  9. 9.Berg Balance Scale.
  10. 10.Late life Function and Disability Instrument.
  11. 11.Get up and go test - stand up and walk 3 meters turn around and walk back to the chair.
  12. 12.Fall Efficacy Scale
  13. 13.Fall incidence and fall severity.
  14. 14.6-minute walk test. The control group will not perform any specific balance training during the 12 week period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2008

Completed
Last Updated

July 2, 2008

Status Verified

November 1, 2005

Enrollment Period

1 year

First QC Date

June 29, 2008

Last Update Submit

July 1, 2008

Conditions

Keywords

FallselderlyBalancespeed of steppingStabilityELDERLY FALLERS

Outcome Measures

Primary Outcomes (5)

  • Berg Balance Scale

    before and 3 months after Training

  • Late life Function and Disability Instrument

    before and after the training

  • Get up and go test

    before and after 3 month of training

  • Step execution test under single and dual task

    before and 3 months after Training

  • Stability tests

    before and 3 months after Training

Interventions

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SorokaUMC

Beersheba, 84105, Israel

Location

Related Publications (1)

  • 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.

Study Officials

  • Itshak Melzer, PhD

    Ben-gurion University of the Negev, Beer-Sheva, Israel

    PRINCIPAL INVESTIGATOR
  • dagan Shvartz, MD

    Ben-Gurion University of the Negev

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 29, 2008

First Posted

July 2, 2008

Study Start

January 1, 2006

Primary Completion

January 1, 2007

Study Completion

June 1, 2007

Last Updated

July 2, 2008

Record last verified: 2005-11

Locations