Fall Prevention in Older Adults Study

Sponsor

University of Arizona (Other)

Overall Status

Completed

CT.gov ID

NCT03176511

Collaborator

(none)

Enrollment

Location

Arms

8.1

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Accidental Fall Postural Balance	Behavioral: A Matter of Balance plus Dual-Task Balance Challenge Group Behavioral: A Matter of Balance Group	N/A

Detailed Description

Fall prevention interventions among community-dwelling older adults are essential. A Matter of Balance (MOB) is one of the most commonly used community-based fall prevention interventions nationally, and is considered the 'fall prevention standard of care'. MOB programs are targeted to reduce the fear of falling and promote physical activity among all older community-dwelling adults. While evidence indicates that the MOB program leads to small, sustained decreases in older adults' perceived fear of falling, there is no evidence of objectively measured balance and gait. Despite its name, MOB focuses on cognitive restructuring to manage concerns about falling, and does not include a balance component. Among community-dwelling older adults, both intact balance and concomitant attention ("dual-tasking") are essential to prevent falls, and dual-task balance components are now requisite per evidence-based fall prevention intervention guidelines.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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).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).

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Novel Dual-Task Balance Challenge to Prevent Falls in Older Adults

Actual Study Start Date :

Jul 25, 2017

Actual Primary Completion Date :

Oct 11, 2017

Actual Study Completion Date :

Mar 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MOB+DTBC Group 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 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. Other Names: MOB+DTBC Group
Active Comparator: MOB Group 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 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). Other Names: MOB Group

Arm

Intervention/Treatment

Experimental: MOB+DTBC Group

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

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.

Other Names:

MOB+DTBC Group

Active Comparator: MOB Group

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

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).

Other Names:

MOB Group

Outcome Measures

Primary Outcome Measures

Balance [Data will be collected at baseline and post-intervention at 4 weeks.]
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).

Secondary Outcome Measures

Gait [Data will be collected at baseline and post-intervention at 4 weeks.]
Gait will be assessed over a distance of 20 meters using the LEGSys™ wearable technology. The system estimates spatiotemporal gait parameters including velocity, stride length, stride time, double support, single support, and stride-to-stride variability, and gait initiation. COM range of motion during walking will be calculated based on the data from the sensor attached to the lower back. Gait will be assessed under usual and maximal walking speeds.
Fear of Falling [Data will be collected at baseline and post-intervention at 4 weeks.]
Fear of Falling is defined as concerns about falling. The Falls Efficacy Scale International (FES-I) is a self-report measure that assesses concerns about falling for 16 commonly performed activities at home and in community settings (e.g. get in/out of chair, walk in crowded places).
3-month incident Fall Rates [Data will be collected post-intervention at months 1, 2 and 3.]
Participants will be provided with 3 monthly fall calendars and asked to mark it daily (X=no fall, F=Fall) and record details of any fall injury/hospitalization on the back of the monthly sheet.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	El Rio Community Health Center	Tucson	Arizona	United States	85745

Sponsors and Collaborators

University of Arizona

Investigators

Principal Investigator: Ruth E Taylor-Piliae, PhD, University of Arizona

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Arizona

ClinicalTrials.gov Identifier:

NCT03176511

Other Study ID Numbers:

RG2017-13

First Posted:

Jun 5, 2017

Last Update Posted:

Oct 25, 2018

Last Verified:

May 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Arizona

older adults

dual task

A Matter of Balance

Study Results

No Results Posted as of Oct 25, 2018