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

Primary Purpose

Fall Injury

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Wait Control
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fall Injury

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

FAST

wait control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 28, 2021
Last Updated
July 28, 2021
Sponsor
University of Saskatchewan
Collaborators
Saskatchewan Health Research Foundation, Saskatchewan Centre for Patient-Oriented Research
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1. Study Identification

Unique Protocol Identification Number
NCT04988334
Brief Title
Improving Capacity to Reduce Fall-Related Injury Risk in Older Adults
Acronym
FAST2
Official Title
Improving Capacity to Reduce Fall-Related Injury Risk in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
Collaborators
Saskatchewan Health Research Foundation, Saskatchewan Centre for Patient-Oriented Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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: Does the FAST improve fall arrest capacity in older women and men as compared to usual activity (wait control period)?, Does FAST increase arm muscle strength, response time, mobility and balance control compared to usual activity? , Are there sex differences in fall risk changes, fall arrest capacity, and chance of head impact? and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fall Injury

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
wait list control to intervention
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FAST
Arm Type
Active Comparator
Arm Description
12 weeks of FAST, 2/week 45 minute sessions with half hour per week of education, same group of men and women
Arm Title
wait control
Arm Type
Placebo Comparator
Arm Description
12 weeks of usual activity prior to intervention, same group of men and women
Intervention Type
Other
Intervention Name(s)
Wait Control
Intervention Description
usual activities
Primary Outcome Measure Information:
Title
Muscle strength dynamic
Description
concentric and eccentric isokinetic dynamometry
Time Frame
12 weeks
Title
Muscle Strength isometric
Description
Hand held dynamometry
Time Frame
12 weeks
Title
Muscle Strength isometric
Description
grip strength
Time Frame
12 weeks
Title
Muscle strength isometric
Description
push off test
Time Frame
12 weeks
Title
response time
Description
signal to touch on force plate
Time Frame
12 weeks
Title
Balance
Description
one leg stand
Time Frame
12 weeks
Title
Balance
Description
tandem stand
Time Frame
12 weeks
Title
Balance
Description
modified clinical test of sensory interaction and balancer
Time Frame
12 weeks
Title
Balance Confidence
Description
Activities balance confidence scale
Time Frame
12 weeks
Title
Fall Risk
Description
Fall Risk for older people in the community-screen
Time Frame
12 weeks
Title
timed up and go test
Description
stand, walk 3 meters, turn and return to sit
Time Frame
12 weeks
Title
chair stand
Description
30-second chair stand test
Time Frame
12 weeks
Title
gait velocity
Description
timed 6 meters within 10 meter walk
Time Frame
12 weeks
Title
fall landing capacity
Description
energy absorption, force, elbow range of motion
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
physical activity
Description
physical activity scale for the elderly
Time Frame
12 weeks
Title
fall history
Description
questionnaire
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cathy o Arnold
Organizational Affiliation
School of Physical Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 2Z4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
de-identified group data to be shared via peer review publication and on request to corresponding author

Learn more about this trial

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

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