NCT02615899

Brief Summary

Background Balance impairment is a key factor contributing to falls in older adults. Conceptually, clinicians may be able to prescribe targeted exercises if specific impairments can be identified. Objective Our objective was to use a model of balance subsystems to identify balance impairments and demonstrate the effectiveness of targeted (matched) exercises to improve balance and reduce fall risk in community-dwelling older adults. The investigators used the Balance Evaluation System Test (BESTest) as the model because it categorizes balance into 6 subsystems. Design Randomized, partially blinded, pretest-post-test clinical trial consisting of 2 Phases: 1. A comparison between impairment-matched exercises and a control, and 2. A comparison between impairment-matched and mismatched exercises. Setting Senior independent living community. Participants Adult volunteers (n = 40; aged 74-94) recruited as sample of convenience who met the criteria. Participants (n = 20) identified with impairment in the biomechanical (BC) constraints subsystem and participants (n = 20) with impairment in anticipatory postural adjustment (APA) subsystem were enrolled and randomized into 2 subgroups (matched and control/delayed mismatched; n = 10 each subgroup). Intervention Phase 1: Participants in the matched subgroup received a 6-week exercise program matched to their impaired subsystem while the mismatched subgroup served as control. Phase 2: Following the delay, participants in the mismatched group received a 6-week exercise program mismatched to their impairment. Measurements Primary outcome variables were scores on the targeted subsystem (BC, APA), BESTest total, Berg Balance Scale, and fear of falling measure. Quality of life was a secondary outcome. Outcome data were collected by the tester blind to pretest scores and group allocation. Results The matched exercise subgroups demonstrated both statistical and clinical improvement in all outcome variables compared to the control; and showed greater improvement in balance impairments compared to the mismatched subgroup, but not in fall risk reduction. Limitations The therapist who administered the pretest knew the subgroup assignment and implemented the exercises. Conclusions Results provide preliminary evidence that using a balance assessment model to identify impairments in the BC and APA subsystems and prescribing targeted exercises reduces these balance impairments for older adults and may warrant future studies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

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

November 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
Last Updated

November 26, 2015

Status Verified

November 1, 2015

Enrollment Period

1.3 years

First QC Date

November 24, 2015

Last Update Submit

November 25, 2015

Conditions

Keywords

Older Adults, Falls

Outcome Measures

Primary Outcomes (4)

  • BESTest total

    Balance

    6 weeks

  • Targeted subsystem of BESTest (APA or BC subsystem)

    Subsystem balance

    6 weeks

  • Berg Balance Scale

    Fall risk indicator

    6 weeks

  • the University of Illinois at Chicago Fear of Falling Measurement (UIC FFM)

    Fall risk indicator

    6 weeks

Secondary Outcomes (1)

  • Short Form Health Survey (SF-12, Version 2; QualityMetric Inc.) questionnaire

    6 weeks

Study Arms (2)

Matched

ACTIVE COMPARATOR

Administer Targeted (specific) balance exercise interventions

Other: Matched: Targeted (specific) balance exercise interventions

Mismatched

ACTIVE COMPARATOR

Administer Untargeted (non-specific) balance exercise interventions

Other: Mismatched: Untargeted (non-specific) balance exercise interventions

Interventions

Eligibility Criteria

Age65 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • individuals who met the criteria for a concurrent psychometric study (older adults aged 65 years and older, cognitively able to understand and follow simple instructions,and able to walk independently with or without an assistive device for more than 100 ft); and demonstrated
  • elevated fracture risk
  • elevated fall risk
  • impaired balance in either the BC or APA subsystem of balance as identified with BESTest.

You may not qualify if:

  • individuals who had:
  • a progressive diseases or unstable medical conditions
  • major surgery in the past 3 months
  • physician's orders not to participate in an exercise program for any reason
  • impairment in both BC and APA subsystems
  • impairments in more than a total of 3 subsystems
  • who were currently receiving treatment for balance or fall prevention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

Study Officials

  • Susan S Smith, PT, PhD

    Drexel University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Research Lab Coordinator, Department of Physical Therapy & Rehabilitation Sciences, Drexel University

Study Record Dates

First Submitted

November 24, 2015

First Posted

November 26, 2015

Study Start

November 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

November 26, 2015

Record last verified: 2015-11

Locations