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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01547988
Other study ID # RRF 2001-056
Secondary ID
Status Completed
Phase N/A
First received February 29, 2012
Last updated March 5, 2012
Start date October 2001
Est. completion date August 2003

Study information

Verified date March 2012
Source Boston University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the effect of a group-based functional and specific balance training program on balance function in healthy older adults. It is commonly considered difficult to improve balance function in healthy older adults. The program included dual-task exercises; physical training exercises and a cognitive task (e.g. reading or reciting a story) performed simultaneously, as well as perturbation exercises, where balance is challenged in unexpected ways.

The investigators hypothesized that following the proposed training, older adults would improve their speed of taking a step in both single and dual task conditions, refine their ability to control balance when standing still and improve their self-reported physical function.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date August 2003
Est. primary completion date February 2003
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

- 65 years or older

- Independently ambulatory (cane acceptable; not walker)

- Score better than 45 on the Berg Balance Scale

- Higher than 24 Mini-Mental Score

Exclusion Criteria:

- Severe focal muscle weakness or visual impairment

- Known neurological disorders (including stroke, Parkinson disease)

- Metastatic cancer

- Use of medication that impairs balance or strength

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
Balance Training Intervention
The intervention group participated in a total of 24 one-hour training sessions over a period of 12 weeks. The training program utilized different size balls as a general tool in a series of progressively more difficult exercises targeting sitting, standing, and gait-related balance control. The program included exercises at five different levels of progressively more challenging balance exercises. Levels 1-4 focused on voluntarily controlled balance exercises, whereas level 5 also included perturbation exercises to trigger automatic compensatory stepping responses. All levels included attention-demanding dual task exercises that required subjects to simultaneously perform motor and cognitive activities.

Locations

Country Name City State
United States NeuroMuscular Research Center, Boston University Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Lars I. E. Oddsson, Patrick Boissy and Itshak Melzer. How to improve gait and balance function in elderly individuals—compliance with principles of training. European Review of Aging and Physical Activity Volume 4, Number 1, 15-23, DOI: 10.1007/s11556-007-0019-9

Melzer I, Oddsson LI. The effect of a cognitive task on voluntary step execution in healthy elderly and young individuals. J Am Geriatr Soc. 2004 Aug;52(8):1255-62. — View Citation

Melzer I, Shtilman I, Rosenblatt N, Oddsson LI. Reliability of voluntary step execution behavior under single and dual task conditions. J Neuroeng Rehabil. 2007 May 29;4:16. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Reaction time of dual task step execution Subjects stand on a force platform and are asked to execute a step as rapidly as possible following a tactile stimulus on their heel while performing a cognitive attention demanding task (Stroop task - call out colors of words that are names of colors, e.g. the word "BLUE" is presented in yellow letters). 12 weeks No
Secondary Late Life Functional Disability Index - LLFDI Self-reported measure of function 12 weeks No
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