Fall InjuryFAST2NCT04988334
Improving Capacity to Reduce Fall-Related Injury Risk in Older Adults
A study of Fall Injury, run by University of Saskatchewan at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall Injury
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2017to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 60 years living in the community
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Fall Injury
- Being tested
- Wait Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wait ControlOther
usual activities
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Wait Control |
| wait control | Placebo comparator | 12 weeks of usual activity prior to intervention, same group of men and women Receives: Other: Wait Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength dynamic
concentric and eccentric isokinetic dynamometry
Measured: 12 weeks
Muscle Strength isometric
Hand held dynamometry
Measured: 12 weeks
Muscle Strength isometric
grip strength
Measured: 12 weeks
Muscle strength isometric
push off test
Measured: 12 weeks
response time
signal to touch on force plate
Measured: 12 weeks
Balance
one leg stand
Measured: 12 weeks
Balance
tandem stand
Measured: 12 weeks
Balance
modified clinical test of sensory interaction and balancer
Measured: 12 weeks
Balance Confidence
Activities balance confidence scale
Measured: 12 weeks
Fall Risk
Fall Risk for older people in the community-screen
Measured: 12 weeks
timed up and go test
stand, walk 3 meters, turn and return to sit
Measured: 12 weeks
chair stand
30-second chair stand test
Measured: 12 weeks
gait velocity
timed 6 meters within 10 meter walk
Measured: 12 weeks
fall landing capacity
energy absorption, force, elbow range of motion
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Jan 2017
- Primary completion31 Dec 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- wait list control to intervention
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation, Saskatchewan Centre for Patient-Oriented Research
- Responsible party
- Principal investigator, Cathy Arnold, University of Saskatchewan
- Investigators
- Cathy o Arnold, Principal investigator, School of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988334
- Sponsor's protocol ID
- University of Saskatchewan
- Acronym
- FAST2
- Status last verified
- Jul 2021
- First submitted
- 28 Jul 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: de-identified group data to be shared via peer review publication and on request to corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Capacity to Reduce Fall-Related Injury Risk in Older Adults
- ClinicalTrials.gov ID
- NCT04988334
- Acronym / sponsor ID
- FAST2 / University of Saskatchewan
- Conditions
- Fall Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation, Saskatchewan Centre for Patient-Oriented Research
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- wait list control to intervention
| Arm | Type | Receives |
|---|---|---|
| FAST | Active comparator | Other: Wait Control12 weeks of FAST, 2/week 45 minute sessions with half hour per week of education, same group of men and women |
| wait control | Placebo comparator | Other: Wait Control12 weeks of usual activity prior to intervention, same group of men and women |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 60 years living in the community
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wait Controlusual activities | Other | FAST, wait control |
Primary outcome
Muscle strength dynamic
Time frame: 12 weeks
concentric and eccentric isokinetic dynamometry
Muscle Strength isometric
Time frame: 12 weeks
Hand held dynamometry
Muscle Strength isometric
Time frame: 12 weeks
grip strength
Muscle strength isometric
Time frame: 12 weeks
push off test
response time
Time frame: 12 weeks
signal to touch on force plate
Balance
Time frame: 12 weeks
one leg stand
Balance
Time frame: 12 weeks
tandem stand
Balance
Time frame: 12 weeks
modified clinical test of sensory interaction and balancer
Balance Confidence
Time frame: 12 weeks
Activities balance confidence scale
Fall Risk
Time frame: 12 weeks
Fall Risk for older people in the community-screen
timed up and go test
Time frame: 12 weeks
stand, walk 3 meters, turn and return to sit
chair stand
Time frame: 12 weeks
30-second chair stand test
gait velocity
Time frame: 12 weeks
timed 6 meters within 10 meter walk
fall landing capacity
Time frame: 12 weeks
energy absorption, force, elbow range of motion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Individual participant dataSharing planned: Undecided. de-identified group data to be shared via peer review publication and on request to corresponding author
Related trials for Fall Injury
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Healthy Participants
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Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
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The Balance and Foot Health Program for Older Adults: A Randomized Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathy o Arnold principal investigator
School of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Fall Injury, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength dynamic (time frame: 12 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.