Fall Prevention in Older Adults Study

NCT03176511 | Completed

• 1 other identifier: RG2017-13
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Poor balance is one of the major risk factors for falling in older adults. A Matter of Balance (MOB) is one of the most commonly used fall prevention programs nationally. Despite its name, MOB focuses on managing concerns about falling, and does not include a balance component. We are testing to see if adding a dual-task balance component (balance and mental thinking) to MOB can improve balance and walking better, than MOB only.

Conditions

Accidental Fall; Postural Balance

Keywords

older adults; dual task; A Matter of Balance

Outcome Measures

Primary Outcomes (1)

• Balance

  Balance will be assessed using LEGSys™ (Locomotion Evaluation and Gait System, BioSensics LLC) wearable technology. This system uses five sensors attached to right and left anterior shins, right and left anterior thighs, and to the posterior lower back. Balance measures will include changes in sway of ankle, hip, and center of mass (COM) in both mediolateral (ML) and anterior/posterior (AP) directions while standing, with feet parallel and in semi-tandem positions, during eyes-open (EO) and eyes-closed (EC) conditions (30 seconds/test).

  Data will be collected at baseline and post-intervention at 4 weeks.

Secondary Outcomes (3)

• Gait

  Data will be collected at baseline and post-intervention at 4 weeks.

• Fear of Falling

  Data will be collected at baseline and post-intervention at 4 weeks.

• 3-month incident Fall Rates

  Data will be collected post-intervention at months 1, 2 and 3.

Study Arms (2)

MOB+DTBC Group

EXPERIMENTAL

A Matter of Balance plus Dual-Task Balance Challenge Group. Standardized MOB classes twice/week for 4 weeks, plus 15 minutes of DTBC each class. Each class is 2 hours 15 minutes.

Behavioral: A Matter of Balance plus Dual-Task Balance Challenge Group

MOB Group

ACTIVE COMPARATOR

A Matter of Balance Group. Standardized MOB classes twice/week for 4 weeks, plus 15 minutes of social time each class. Each class is 2 hours 15 minutes.

Behavioral: A Matter of Balance Group

Interventions

A Matter of Balance plus Dual-Task Balance Challenge Group BEHAVIORAL

Participants will receive the standard MOB classes, along with a 15-min DTBC each class, i.e., right and left foot ankle-reaching to three differently colored markers. Three colored dots are placed on the ground in an arc, using different colored stick-on dots. A chair can be placed in front of the color pattern, as needed for safety.

Also known as: MOB+DTBC Group

MOB+DTBC Group

A Matter of Balance Group BEHAVIORAL

Participants will receive the standard MOB class, taught by a certified MOB, using course materials developed by MaineHealth's Partnering for Healthy Aging (http://www.mainehealth.org/pfha).

Also known as: MOB Group

MOB Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Community-dwelling older adults from all sex/gender and racial/ethnic groups, aged ≥ 60 years, at high fall risk (FRQ=Fall Risk Questionnaire score \> 4), who live in the greater Tucson, AZ area.

You may not qualify if:

• Older adults currently attending MOB or other fall prevention classes (e.g. Fall Proof), having a severe mobility disorder (e.g., unable to walk 15 feet with an assistive device), severe visual or hearing impairment, non-English speaking, lack of decision-making capacity, unable to provide informed consent, serious psychiatric disorder (e.g., schizophrenia), moderately-severe depression (PHQ-9=Patient Health Questionnaire ≥ 15), cognitive impairment (MMSE=Mini-Mental Status Exam ≤ 23), or serious medical condition (e.g., cancer treatments).

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

El Rio Community Health Center

Tucson, Arizona, 85745, United States

Location

Study Officials

• Ruth E Taylor-Piliae, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: As with any active intervention, participants will know their group assignment and double-blinding is not possible. Of note, our primary outcome measures are objective and require post-processing, thus study staff collecting the data will be "blinded" to participant results. Further, our bio-engineer post-processor will be blinded to study assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The proposed pilot study will employ a single-blind, two-group randomized clinical trial. We will randomly assign 24 community-dwelling older adults (≥ 60 years) from an underserved population who are at high fall risk to either: A.) 4-week MOB+DTBC intervention, or B.) 4-week MOB only intervention (n=12/group).

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 5, 2017
• Study Start: July 25, 2017
• Primary Completion: October 11, 2017
• Study Completion: March 30, 2018
• Last Updated: October 25, 2018

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)