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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04988334
Other study ID # University of Saskatchewan
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date January 31, 2019

Study information

Verified date July 2021
Source University of Saskatchewan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date January 31, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Wait Control
usual activities

Locations

Country Name City State
Canada University of Saskatchewan Saskatoon Saskatchewan

Sponsors (3)

Lead Sponsor Collaborator
University of Saskatchewan Saskatchewan Centre for Patient-Oriented Research, Saskatchewan Health Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

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