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Clinical Trials/NCT02615899
NCT02615899CompletedNot Applicable

Effectiveness of Impairment Specific Exercises for Balance and Fall Risk in Community-Living Older Adults at Risk: A Randomized Controlled Trial

Drexel University2 sites in 1 country40 target enrollmentStarted: November 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
2
Primary Endpoint
BESTest total

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to 99 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

BESTest total

Time Frame: 6 weeks

Balance

Targeted subsystem of BESTest (APA or BC subsystem)

Time Frame: 6 weeks

Subsystem balance

Berg Balance Scale

Time Frame: 6 weeks

Fall risk indicator

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

Time Frame: 6 weeks

Fall risk indicator

Secondary Outcomes

  • Short Form Health Survey (SF-12, Version 2; QualityMetric Inc.) questionnaire(6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sheri Silfies

Associate Professor, Research Lab Coordinator, Department of Physical Therapy & Rehabilitation Sciences, Drexel University

Drexel University

Study Sites (2)

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