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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United States1 site
  • Drexel University

    Philadelphia, Pennsylvania, 19102

Other trials in United States

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.

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 groups in NCT02615899
Study groupRoleWhat they receive
MatchedActive comparatorAdminister Targeted (specific) balance exercise interventions
Receives: Other: Matched: Targeted (specific) balance exercise interventions
MismatchedActive comparatorAdminister 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.

  1. BESTest total

    Balance

    Measured: 6 weeks

  2. Targeted subsystem of BESTest (APA or BC subsystem)

    Subsystem balance

    Measured: 6 weeks

  3. Berg Balance Scale

    Fall risk indicator

    Measured: 6 weeks

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

    Fall risk indicator

    Measured: 6 weeks

Secondary outcomes (1)
  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.

  1. First posted26 Nov 2015 (estimated)
  2. Study startNov 2013
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

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)
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

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.

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