Effectiveness of Impairment Specific Exercises for Balance and Fall Risk in Community-Living Older Adults at Risk: A Randomized Controlled Trial

Exercise Therapy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615899
• Other study ID #: 1305002061
• Status: Completed
• Phase: N/A
• First received: November 24, 2015
• Last updated: November 25, 2015
• Start date: November 2013
• Est. completion date: February 2015

Study information

• Verified date: November 2015
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 99 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Balance, Postural
• Exercise Therapy

Intervention

Other:
• Matched: Targeted (specific) balance exercise interventions

• Mismatched: Untargeted (non-specific) balance exercise interventions

Locations

Country	Name	City	State
United States	Drexel University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Drexel University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BESTest total	Balance	6 weeks	No
Primary	Targeted subsystem of BESTest (APA or BC subsystem)	Subsystem balance	6 weeks	No
Primary	Berg Balance Scale	Fall risk indicator	6 weeks	No
Primary	the University of Illinois at Chicago Fear of Falling Measurement (UIC FFM)	Fall risk indicator	6 weeks	No
Secondary	Short Form Health Survey (SF-12, Version 2; QualityMetric Inc.) questionnaire	Quality of Life indicator	6 weeks	No