Clinical trial NCT02615899: Effectiveness of Impairment Specific Exercises for Balance and Fall Risk in Community-Living Older Adults at Risk: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance, Postural
Exercise Therapy
Keywords: Older Adults, Falls
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2015-11-26
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: BESTest total
timeFrame: 6 weeks
measure: Targeted subsystem of BESTest (APA or BC subsystem)
timeFrame: 6 weeks
measure: Berg Balance Scale
timeFrame: 6 weeks
measure: the University of Illinois at Chicago Fear of Falling Measurement (UIC FFM)
timeFrame: 6 weeks
Secondary outcomes:
measure: Short Form Health Survey (SF-12, Version 2; QualityMetric Inc.) questionnaire
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Susan S Smith, PT, PhD
role: STUDY_CHAIR
References: