Balance, PosturalNCT02615899
Effectiveness of Impairment Specific Exercises for Balance and Fall Risk in Community-Living Older Adults at Risk: A Randomized Controlled Trial
A study testing Matched: Targeted (specific) balance exercise interventions and Mismatched: Untargeted (non-specific) balance exercise interventions in people with Balance, Postural and Exercise Therapy, run by Drexel University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Balance, Postural, Exercise Therapy
- What is being tested?
- Matched: Targeted (specific) balance exercise interventions and Mismatched: Untargeted (non-specific) balance exercise interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 99 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Balance, Postural, Exercise Therapy
- Being tested
- Matched: Targeted (specific) balance exercise interventions, Mismatched: Untargeted (non-specific) balance exercise interventions
- Keywords
- Older Adults, Falls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matched: Targeted (specific) balance exercise interventionsOther
Mismatched: Untargeted (non-specific) balance exercise interventionsOther
| Study group | Role | What they receive |
|---|---|---|
| Matched | Active comparator | Administer Targeted (specific) balance exercise interventions Receives: Other: Matched: Targeted (specific) balance exercise interventions |
| Mismatched | Active comparator | Administer Untargeted (non-specific) balance exercise interventions Receives: Other: Mismatched: Untargeted (non-specific) balance exercise interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
BESTest total
Balance
Measured: 6 weeks
Targeted subsystem of BESTest (APA or BC subsystem)
Subsystem balance
Measured: 6 weeks
Berg Balance Scale
Fall risk indicator
Measured: 6 weeks
the University of Illinois at Chicago Fear of Falling Measurement (UIC FFM)
Fall risk indicator
Measured: 6 weeks
Secondary outcomes (1)
Short Form Health Survey (SF-12, Version 2; QualityMetric Inc.) questionnaire
Quality of Life indicator
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startNov 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance, PosturalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheri Silfies, Drexel University
- Investigators
- Susan S Smith, PT, PhD, Study chair, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615899
- Sponsor's protocol ID
- 1305002061
- Status last verified
- Nov 2015
- First submitted
- 24 Nov 2015
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Impairment Specific Exercises for Balance and Fall Risk in Community-Living Older Adults at Risk: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02615899
- Acronym / sponsor ID
- 1305002061
- Conditions
- Balance, Postural, Exercise Therapy
- Keywords
- Older Adults, Falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Matched | Active comparator | Other: Matched: Targeted (specific) balance exercise interventionsAdminister Targeted (specific) balance exercise interventions |
| Mismatched | Active comparator | Other: Mismatched: Untargeted (non-specific) balance exercise interventionsAdminister Untargeted (non-specific) balance exercise interventions |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- individuals who had:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Matched: Targeted (specific) balance exercise interventions | Other | Matched |
| Mismatched: Untargeted (non-specific) balance exercise interventions | Other | Mismatched |
Primary outcome
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
1 secondary outcome
Short Form Health Survey (SF-12, Version 2; QualityMetric Inc.) questionnaire
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan S Smith, PT, PhD study chair
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Matched: Targeted (specific) balance exercise interventions and Mismatched: Untargeted (non-specific) balance exercise interventions in people with Balance, Postural and Exercise Therapy, run by Drexel University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BESTest total (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2015.