NCT01547988

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2001

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

February 29, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

Enrollment Period

1.3 years

First QC Date

February 29, 2012

Last Update Submit

March 5, 2012

Conditions

Accidental Falls

Keywords

AgingFallsBalance ControlVoluntary Step Execution TestDual-TaskSelf-reported function

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Late Life Functional Disability Index - LLFDI

    12 weeks

Study Arms (2)

Balance Training Intervention

EXPERIMENTAL

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

Other: Balance Training Intervention

Reference Group

NO INTERVENTION
Other: Balance Training Intervention

Interventions

Balance Training InterventionOTHER

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.

Balance Training InterventionReference Group

Eligibility Criteria

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

You may qualify if:

  • years or older
  • Independently ambulatory (cane acceptable; not walker)
  • Score better than 45 on the Berg Balance Scale
  • Higher than 24 Mini-Mental Score

You may not qualify if:

  • Severe focal muscle weakness or visual impairment
  • Known neurological disorders (including stroke, Parkinson disease)
  • Metastatic cancer
  • Use of medication that impairs balance or strength

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NeuroMuscular Research Center, Boston University

Boston, Massachusetts, 02215, United States

Location

Related 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

    BACKGROUND

  • 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. doi: 10.1111/j.1532-5415.2004.52353.x.

    PMID: 15271111BACKGROUND

  • 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. doi: 10.1186/1743-0003-4-16.

    PMID: 17535424BACKGROUND

Study Officials

  • Lars IE Oddsson, PhD

    NeuroMuscular Research Center, Boston University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 29, 2012

First Posted

March 8, 2012

Study Start

October 1, 2001

Primary Completion

February 1, 2003

Study Completion

August 1, 2003

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations

US(1)