Improving Capacity to Reduce Fall-Related Injury Risk in Older Adults (FAST2)

July 28, 2021 updated by: Cathy Arnold, University of Saskatchewan
Fall Arrest Strategy Training (FAST) is a unique, simple exercise program designed to improve one's ability to prevent injury when a fall is unavoidable. Women are more likely to participate in fall prevention programming than men despite risk of serious fall related injuries such as head injury similar in both men and women. The purpose of this project is to test differences between men and women's physical capacity to control the downward descent of a forward fall and prevent injury and to understand factors that influence participation of women and men in fall prevention programming. A total of 60 seniors (30 men and 30 women) age 60 years or older will do their regular activities for 12 weeks followed by 12 weeks of FAST training. They will be tested before and after for muscle strength, balance and their ability to land and descend in a simulated forward fall using a safe protocol in our lab. Group discussions among women and men after FAST will help us determine facilitators and barriers to exercise participation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this proposed study is to advance our knowledge of this innovative and simple training program, FAST, to determine if it has potential to improve the physical capacity to arrest a fall and reduce injury risk in older community-dwelling women and men. Using our novel lab-based energy absorption and strength measures, we will be able to compare fall-arrest capacity changes in older men and women.This study will also help to inform strategies to engage older men in exercise programming.

Research Goals and Objectives: The principal research questions of this study are:

  1. Does the FAST improve fall arrest capacity in older women and men as compared to usual activity (wait control period)?,
  2. Does FAST increase arm muscle strength, response time, mobility and balance control compared to usual activity? ,
  3. Are there sex differences in fall risk changes, fall arrest capacity, and chance of head impact? and
  4. Do men differ from women in their perceptions of the barriers and facilitators to participating in FAST? The hypotheses are that: 1) FAST will result in greater improvements in energy absorption, UE strength, response time and mobility compared to usual activity for both older men and women; however 2) men will demonstrate enhanced fall arrest capacity and 3) will identify unique barriers and facilitators to participation compared to women.

The study is a quasi-experimental pre-post design with a wait list control period where 60 men and women, age 60 years or older will be recruited to participate in FAST.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 2Z4
        • University of Saskatchewan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged 60 years living in the community

Exclusion Criteria:

  • recent upper body injury or pain,
  • recent or history of more than one distal radial fracture,
  • history of upper extremity neurological conditions or conditions contradicting upper extremity strength testing or training,
  • signs of severe cognitive impairment identified with the mini-Cog
  • unable to safely ambulate independently in the community

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FAST
12 weeks of FAST, 2/week 45 minute sessions with half hour per week of education, same group of men and women
usual activities
Placebo Comparator: wait control
12 weeks of usual activity prior to intervention, same group of men and women
usual activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength dynamic
Time Frame: 12 weeks
concentric and eccentric isokinetic dynamometry
12 weeks
Muscle Strength isometric
Time Frame: 12 weeks
Hand held dynamometry
12 weeks
Muscle Strength isometric
Time Frame: 12 weeks
grip strength
12 weeks
Muscle strength isometric
Time Frame: 12 weeks
push off test
12 weeks
response time
Time Frame: 12 weeks
signal to touch on force plate
12 weeks
Balance
Time Frame: 12 weeks
one leg stand
12 weeks
Balance
Time Frame: 12 weeks
tandem stand
12 weeks
Balance
Time Frame: 12 weeks
modified clinical test of sensory interaction and balancer
12 weeks
Balance Confidence
Time Frame: 12 weeks
Activities balance confidence scale
12 weeks
Fall Risk
Time Frame: 12 weeks
Fall Risk for older people in the community-screen
12 weeks
timed up and go test
Time Frame: 12 weeks
stand, walk 3 meters, turn and return to sit
12 weeks
chair stand
Time Frame: 12 weeks
30-second chair stand test
12 weeks
gait velocity
Time Frame: 12 weeks
timed 6 meters within 10 meter walk
12 weeks
fall landing capacity
Time Frame: 12 weeks
energy absorption, force, elbow range of motion
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
physical activity
Time Frame: 12 weeks
physical activity scale for the elderly
12 weeks
fall history
Time Frame: 12 weeks
questionnaire
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Cathy o Arnold, School of Physical Therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

January 31, 2019

Study Registration Dates

First Submitted

July 28, 2021

First Submitted That Met QC Criteria

July 28, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University of Saskatchewan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

de-identified group data to be shared via peer review publication and on request to corresponding author

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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