Effectiveness of Impairment Specific Exercises for Balance and Fall Risk in Community-Living Older Adults at Risk: A Randomized Controlled Trial
1 other identifier
interventional
40
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2013
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 24, 2015
CompletedFirst Posted
Study publicly available on registry
November 26, 2015
CompletedNovember 26, 2015
November 1, 2015
1.3 years
November 24, 2015
November 25, 2015
Conditions
Keywords
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 COMPARATORAdminister Targeted (specific) balance exercise interventions
Mismatched
ACTIVE COMPARATORAdminister Untargeted (non-specific) balance exercise interventions
Interventions
Eligibility Criteria
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
Study Officials
- STUDY CHAIR
Susan S Smith, PT, PhD
Drexel University
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