NCT04988334

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
Last Updated

August 3, 2021

Status Verified

July 1, 2021

Enrollment Period

2 years

First QC Date

July 28, 2021

Last Update Submit

July 28, 2021

Conditions

Fall Injury

Outcome Measures

Primary Outcomes (14)

  • Muscle strength dynamic

    concentric and eccentric isokinetic dynamometry

    12 weeks

  • Muscle Strength isometric

    Hand held dynamometry

    12 weeks

  • Muscle Strength isometric

    grip strength

    12 weeks

  • Muscle strength isometric

    push off test

    12 weeks

  • response time

    signal to touch on force plate

    12 weeks

  • Balance

    one leg stand

    12 weeks

  • Balance

    tandem stand

    12 weeks

  • Balance

    modified clinical test of sensory interaction and balancer

    12 weeks

  • Balance Confidence

    Activities balance confidence scale

    12 weeks

  • Fall Risk

    Fall Risk for older people in the community-screen

    12 weeks

  • timed up and go test

    stand, walk 3 meters, turn and return to sit

    12 weeks

  • chair stand

    30-second chair stand test

    12 weeks

  • gait velocity

    timed 6 meters within 10 meter walk

    12 weeks

  • fall landing capacity

    energy absorption, force, elbow range of motion

    12 weeks

Other Outcomes (2)

  • physical activity

    12 weeks

  • fall history

    12 weeks

Study Arms (2)

FAST

ACTIVE COMPARATOR

12 weeks of FAST, 2/week 45 minute sessions with half hour per week of education, same group of men and women

Other: Wait Control

wait control

PLACEBO COMPARATOR

12 weeks of usual activity prior to intervention, same group of men and women

Other: Wait Control

Interventions

Wait ControlOTHER

usual activities

FASTwait control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 60 years living in the community

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 2Z4, Canada

Location

Study Officials

  • Cathy o Arnold

    School of Physical Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: wait list control to intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 28, 2021

First Posted

August 3, 2021

Study Start

January 1, 2017

Primary Completion

December 31, 2018

Study Completion

January 31, 2019

Last Updated

August 3, 2021

Record last verified: 2021-07

Locations

CA(1)