- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02615899
Effectiveness of Impairment Specific Exercises for Balance and Fall Risk in Community-Living Older Adults at Risk: A Randomized Controlled Trial
November 25, 2015 updated by: Sheri Silfies, Drexel University
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 Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19102
- Drexel University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 99 years (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Matched
Administer Targeted (specific) balance exercise interventions
|
|
Active Comparator: Mismatched
Administer Untargeted (non-specific) balance exercise interventions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BESTest total
Time Frame: 6 weeks
|
Balance
|
6 weeks
|
Targeted subsystem of BESTest (APA or BC subsystem)
Time Frame: 6 weeks
|
Subsystem balance
|
6 weeks
|
Berg Balance Scale
Time Frame: 6 weeks
|
Fall risk indicator
|
6 weeks
|
the University of Illinois at Chicago Fear of Falling Measurement (UIC FFM)
Time Frame: 6 weeks
|
Fall risk indicator
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short Form Health Survey (SF-12, Version 2; QualityMetric Inc.) questionnaire
Time Frame: 6 weeks
|
Quality of Life indicator
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Susan S Smith, PT, PhD, Drexel University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
November 24, 2015
First Submitted That Met QC Criteria
November 25, 2015
First Posted (Estimate)
November 26, 2015
Study Record Updates
Last Update Posted (Estimate)
November 26, 2015
Last Update Submitted That Met QC Criteria
November 25, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1305002061
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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