- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04988334
Improving Capacity to Reduce Fall-Related Injury Risk in Older Adults (FAST2)
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada, S7N 2Z4
- University of Saskatchewan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Cathy o Arnold, School of Physical Therapy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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