Training Improves Balance Control

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Boston University

ClinicalTrials.gov Identifier:

NCT01547988

First received: February 29, 2012

Last updated: March 5, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 29, 2012

Last Updated Date

March 5, 2012

Start Date ^ICMJE

October 2001

Primary Completion Date

February 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Reaction time of dual task step execution [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01547988 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Late Life Functional Disability Index - LLFDI [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Self-reported measure of function

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Training Improves Balance Control

Official Title ^ICMJE

Improving Balance Control and Self-Reported Lower Extremity Function in Community Dwelling Older Adults - A Randomized Control Study

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Accidental Falls

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: Balance Training Intervention
The Balance Training Intervention group received 24 training sessions over three months that included perturbation as well as dual-task exercises.

Intervention: Other: Balance Training Intervention
No Intervention: Reference Group
Intervention: Other: Balance Training Intervention

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2003

Primary Completion Date

February 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

65 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01547988

Other Study ID Numbers ^ICMJE

RRF 2001-056

Has Data Monitoring Committee

Responsible Party

Boston University

Study Sponsor ^ICMJE

Boston University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Lars IE Oddsson, PhD

NeuroMuscular Research Center, Boston University

Information Provided By

Boston University

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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