Fall InjuryNCT05260034
Minimizing Fall-Related Injury in Older Adults: a Motor Learning Approach
A study testing FAST Program and Otago Exercise Program in people with Fall Injury and Fall Patients, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
Falls are the leading cause of accidental injury and injury-related death among older adults. Despite evidence that falls can be prevented, fall related injuries have not declined over time. Current fall injury prevention techniques targeting mobility and bone strength have merit yet their effectiveness is limited. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fall Injury, Fall Patients, Mobility Limitation
- What is being tested?
- FAST Program and Otago Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2022to 5 Apr 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Have balance impairment as indicated by <10s on unipedal stance
- History of fall injury in the last year; or, two more falls in the last year; or, afraid of falling because of problems with balance or walking
- Have no history of tumbling, gymnastic or martial art experience or currently engagement of 150+ minutes/week of vigorour aerobic activity
- No clinical osteoporosis
- DEXA (dual energy X-ray absorptiometry) determined bone mineral density of the hip of t is greater than or equal to -2.3
Who cannot join
- Outside of age range
- Unable to speak or comprehend written/spoken English
- Cognitive impairment as indicated by Saint Louis University Memory Scale (<25)
- Unable to ambulate household distances
- Intact standing balance as indicated by >10s of unipedal stance
- Currently receiving physical therapy
Show all 11Show fewer
- Presence of clinical osteoporosis
- Uncorrected vision or hearing or vestibular dysfunction
- Major neurological conditions, such as stroke, Parkinson's Disease, vertigo that affect the ability to ambulate or perform daily tasks
- Currently taking medications, including, coumadin, dual oral anticoagulants (apixaban, rivaroxaban), lovenox
- Conditions may lead to (internal) bleeding, such as thrombocytopenia, hemorrhagic diathesis
Trial locations and contacts
1 site in 1 country.
About this study
Falls are the leading cause of accidental injury and injury-related death among older adults. Despite evidence that falls can be prevented, fall related injuries have not declined over time. Current fall injury prevention techniques targeting mobility and bone strength have merit yet their effectiveness is limited. Indeed, a recent Patient Centered Outcomes Research Institute/National Institute on Aging funded pragmatic trial of individualized multifactorial strategy to prevent serious fall injuries in over 5500 seniors revealed no difference in fall injuries between the intervention and standard care arm. The inconclusive results of the investigation may be due in part to focusing on fall prevention rather than mitigation of fall-related impact acceleration and forces - the "fundamental variables" for injury prevention. A fall-related injury occurs when the body hits the ground with force that is greater than tissue strength. Development of innovative approaches that focus on fundamental variables of injury prevention is needed.
Read the detailed description
Impact forces and body accelerations can be mitigated by performing specific movement patterns during the impact phase of a fall. The investigators, along with others have postulated and provided preliminary evidence that older adults can learn specific movement patterns (enacted during the impact phase of a fall), such as the tuck and roll that significantly reduce impact forces and minimize the risk of injury. The investigators' recent Randomized Clinical Trial (RCT) that examined the FAlling Safely Training (FAST) program in 17 older adults with low fall risk found that following 2 hours of training, the FAST group reduced their hip impact force by 33% and head acceleration by 59% and demonstrated retention. The procedures were feasible and safe in relatively healthy older adults with low fall risk. Despite the promise of this approach, perhaps the most important issue for real world translation is whether at-fall risk older adults with known balance impairment, a key target group who would most benefit from this training, can safely learn to fall with reduced impact forces and thus potentially fewer injuries using this paradigm. The immediate goal of this investigation is to determine the safety and feasibility of FAST training in an at-fall risk older adult group, the key measurable stages of FAST mastery, and, most importantly, the effect size, compared to modified Otago Exercise Program (an evidence-based fall risk reduction program) controls, to inform a larger future trial. To maximize safety, participants will utilize a protective helmet, and hip protector while landing on a cushioned pad. In addition, using a motor learning approach, the investigators will determine and measure key stages of the technique that can be mastered and measured as intermediate measures to document training progression.
- Conditions
- Fall Injury, Fall Patients, Mobility Limitation
- Being tested
- FAST Program, Otago Exercise Program
- Keywords
- Falls, Physical Therapy, Injury Prevention
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAST ProgramOther
This program aims to teach how to effectively reduce impact forces during a sideways fall by 1) changing the trunk/knee angles during descent to decrease body acceleration, 2) using a rolling movement to allow for an optimal distribution of impact forces applied to any site along the contact path; and 3) tucking the chin to protect the head.
Otago Exercise ProgramOther
The Otago Exercise Program (OEP) was chosen, rather than no control intervention, to increase the level of evidence required to demonstrate efficacy, and because, similar to the safe fall training used here, it was designed to be performed individually or in small groups.
| Study group | Role | What they receive |
|---|---|---|
| Otago Group | Active comparator | The control group will receive balance exercises adapted from the evidenced-based Otago Exercise program. Briefly, all eight sessions (~30 min) will involve balance exercises and strength exercises using ankle weights, and will progressively increase as performance improves by increasing resistance or the difficulty of the balance exercises (e.g., reducing base of support). Receives: Other: Otago Exercise Program |
| FAST Group | Experimental | Participants randomized to the intervention arm will undergo the FAST program, a progressive safe-falling training based on the tuck and roll strategy. As part of the FAST program, participants will train 30 minutes twice a week for a period of four weeks under the supervision of a trained researcher. Participants will wear protective gear (knee, hip, head) and they will complete a 10-minute stretching exercise routine to minimize the risk of injury. Receives: Other: FAST Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical discomfort related to the intervention
The hypothesis is that there will be minimally greater musculoskeletal discomfort in the FAST group that than in the Otago Exercise Program group, but no difference in adverse events. Physical discomfort will be recorded by an 11-point numerical rating scale (ranging from 0, no discomfort to 10, worst imaginable discomfort). Participants will self-report their discomfort, including the physical location and severity on a standardized body map.
Measured: The physical discomfort scale will be utilized through the participant's involvement in the study, approximately five months.
Participant ability to master the intervention
The investigators hypothesize that at least 2/3 of FAST participants will pass through a series of technique mastery and eventually progress to the final stage of the training. Mastery of technique will be measured by scoring the participants' technique based on predetermined, standardized competency criteria.
Measured: Feasibility will be measured during the intervention, which will last four weeks.
Determining FAST efficacy in reducing hip impact force, versus Otago Exercise Program (OEP).
The first part of the hypothesis postulates that when compared to baseline, FAST participants will show greater reduction in hip impact force than OEP participants immediately post-training. The second part of the hypothesis postulates that compared to baseline, FAST participants will show greater reduction in hip impact force than OEP participants at three months post-training. The impact velocity and impact acceleration of the hip will be computed based on the hip trajectory recorded by motion capture system.
Measured: The outcome will measured at the baseline, one-week post-intervention, and three-months post-intervention.
Determining FAST efficacy in reducing head acceleration, versus Otago Exercise Program (OEP).
The first part of the hypothesis postulates that when compared to baseline, FAST participants will show greater reduction in head acceleration than OEP participants immediately post-training. The second part of the hypothesis postulates that compared to baseline, FAST participants will show greater reduction in head acceleration than OEP participants at three months post-training. Information will be collected on upper limb impact by utilizing conformal sensors during falls.
Measured: The outcome will be measured during the baseline, one-week post-intervention, and three-months post-intervention.
Number of adverse events
Any adverse events (AEs) and serious adverse events (SAEs) will be recorded on the Council for International Organizations of Medical Sciences' CIOMS-E2A form by the researchers. The definition of adverse event and serious adverse events will follow that of the International Council for Harmonization.
Measured: AEs and SAEs will be monitored through participant involvement of the study, approximately five months.
Secondary outcomes (2)
The number of head impacts
The number of times that the head makes contact with the ground will be recorded at each assessment.
Measured: The outcome will be measured during the baseline, one-week post-intervention, and three-months post-intervention.
The movement strategy of falls
The trunk angle, knee angle and trunk rotation at impact will be calculated based on the motion capture data, which will measure the body's angles and rotation during the fall. Each assessment will have the right and left side falls for 2 trials each and 2 backward falls, in a total.
Measured: The trunk angle, knee angle and trunk rotation of each fall will be assessed at all assessments (baseline, one-week post-intervention, and 3-month follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start18 Jul 2022
- Primary completion5 Apr 2024
- Study completion5 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fall InjuryStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jacob Sosnoff, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260034
- Sponsor's protocol ID
- STUDY00147362
- Other IDs
- R21AG073892
- Status last verified
- Nov 2024
- First submitted
- 24 Jan 2022
- Last updated
- 6 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zanotto A, Zanotto T, Alexander NB, Sosnoff JJ. Views and experiences of older people taking part in a safe-falling training program: Lessons learned from the FAlling Safely Training (FAST) trial. BMC Geriatr. 2024 Oct 11;24(1):818. doi: 10.1186/s12877-024-05382-7.
PubMed 39394576Zanotto T, Chen L, Fang J, Bhattacharya SB, Alexander NB, Sosnoff JJ. Minimizing fall-related injuries in at-risk older adults: The falling safely training (FAST) study protocol. Contemp Clin Trials Commun. 2023 Apr 11;33:101133. doi: 10.1016/j.conctc.2023.101133. eCollection 2023 Jun.
PubMed 37122489
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimizing Fall-Related Injury in Older Adults: a Motor Learning Approach
- ClinicalTrials.gov ID
- NCT05260034
- Acronym / sponsor ID
- STUDY00147362
- Conditions
- Fall Injury, Fall Patients, Mobility Limitation
- Keywords
- Falls, Physical Therapy, Injury Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 2 Mar 2022 (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.
Falls are the leading cause of accidental injury and injury-related death among older adults. Despite evidence that falls can be prevented, fall related injuries have not declined over time. Current fall injury prevention techniques targeting mobility and bone strength have merit yet their effectiveness is limited. Indeed, a recent Patient Centered Outcomes Research Institute/National Institute on Aging funded pragmatic trial of individualized multifactorial strategy to prevent serious fall injuries in over 5500 seniors revealed no difference in fall injuries between the intervention and standard care arm. The inconclusive results of the investigation may be due in part to focusing on fall prevention rather than mitigation of fall-related impact acceleration and forces - the "fundamental variables" for injury prevention. A fall-related injury occurs when the body hits the ground with force that is greater than tissue strength. Development of innovative approaches that focus on fundamental variables of injury prevention is needed.
Detailed description
Impact forces and body accelerations can be mitigated by performing specific movement patterns during the impact phase of a fall. The investigators, along with others have postulated and provided preliminary evidence that older adults can learn specific movement patterns (enacted during the impact phase of a fall), such as the tuck and roll that significantly reduce impact forces and minimize the risk of injury. The investigators' recent Randomized Clinical Trial (RCT) that examined the FAlling Safely Training (FAST) program in 17 older adults with low fall risk found that following 2 hours of training, the FAST group reduced their hip impact force by 33% and head acceleration by 59% and demonstrated retention. The procedures were feasible and safe in relatively healthy older adults with low fall risk. Despite the promise of this approach, perhaps the most important issue for real world translation is whether at-fall risk older adults with known balance impairment, a key target group who would most benefit from this training, can safely learn to fall with reduced impact forces and thus potentially fewer injuries using this paradigm. The immediate goal of this investigation is to determine the safety and feasibility of FAST training in an at-fall risk older adult group, the key measurable stages of FAST mastery, and, most importantly, the effect size, compared to modified Otago Exercise Program (an evidence-based fall risk reduction program) controls, to inform a larger future trial. To maximize safety, participants will utilize a protective helmet, and hip protector while landing on a cushioned pad. In addition, using a motor learning approach, the investigators will determine and measure key stages of the technique that can be mastered and measured as intermediate measures to document training progression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Otago Group | Active comparator | Other: Otago Exercise ProgramThe control group will receive balance exercises adapted from the evidenced-based Otago Exercise program. Briefly, all eight sessions (~30 min) will involve balance exercises and strength exercises using ankle weights, and will progressively increase as performance improves by increasing resistance or the difficulty of the balance exercises (e.g., reducing base of support). |
| FAST Group | Experimental | Other: FAST ProgramParticipants randomized to the intervention arm will undergo the FAST program, a progressive safe-falling training based on the tuck and roll strategy. As part of the FAST program, participants will train 30 minutes twice a week for a period of four weeks under the supervision of a trained researcher. Participants will wear protective gear (knee, hip, head) and they will complete a 10-minute stretching exercise routine to minimize the risk of injury. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Have balance impairment as indicated by <10s on unipedal stance
- History of fall injury in the last year; or, two more falls in the last year; or, afraid of falling because of problems with balance or walking
- Have no history of tumbling, gymnastic or martial art experience or currently engagement of 150+ minutes/week of vigorour aerobic activity
- No clinical osteoporosis
- DEXA (dual energy X-ray absorptiometry) determined bone mineral density of the hip of t is greater than or equal to -2.3
Key exclusion criteria (11 listed)
- Outside of age range
- Unable to speak or comprehend written/spoken English
- Cognitive impairment as indicated by Saint Louis University Memory Scale (<25)
- Unable to ambulate household distances
- Intact standing balance as indicated by >10s of unipedal stance
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 |
|---|---|---|
| FAST ProgramThis program aims to teach how to effectively reduce impact forces during a sideways fall by 1) changing the trunk/knee angles during descent to decrease body acceleration, 2) using a rolling movement to allow for an optimal distribution of impact forces applied to any site along the contact path; and 3) tucking the chin to protect the head. | Other | FAST Group |
| Otago Exercise ProgramThe Otago Exercise Program (OEP) was chosen, rather than no control intervention, to increase the level of evidence required to demonstrate efficacy, and because, similar to the safe fall training used here, it was designed to be performed individually or in small groups. | Other | Otago Group |
Primary outcome
Physical discomfort related to the intervention
Time frame: The physical discomfort scale will be utilized through the participant's involvement in the study, approximately five months.
The hypothesis is that there will be minimally greater musculoskeletal discomfort in the FAST group that than in the Otago Exercise Program group, but no difference in adverse events. Physical discomfort will be recorded by an 11-point numerical rating scale (ranging from 0, no discomfort to 10, worst imaginable discomfort). Participants will self-report their discomfort, including the physical location and severity on a standardized body map.
Participant ability to master the intervention
Time frame: Feasibility will be measured during the intervention, which will last four weeks.
The investigators hypothesize that at least 2/3 of FAST participants will pass through a series of technique mastery and eventually progress to the final stage of the training. Mastery of technique will be measured by scoring the participants' technique based on predetermined, standardized competency criteria.
Determining FAST efficacy in reducing hip impact force, versus Otago Exercise Program (OEP).
Time frame: The outcome will measured at the baseline, one-week post-intervention, and three-months post-intervention.
The first part of the hypothesis postulates that when compared to baseline, FAST participants will show greater reduction in hip impact force than OEP participants immediately post-training. The second part of the hypothesis postulates that compared to baseline, FAST participants will show greater reduction in hip impact force than OEP participants at three months post-training. The impact velocity and impact acceleration of the hip will be computed based on the hip trajectory recorded by motion capture system.
Determining FAST efficacy in reducing head acceleration, versus Otago Exercise Program (OEP).
Time frame: The outcome will be measured during the baseline, one-week post-intervention, and three-months post-intervention.
The first part of the hypothesis postulates that when compared to baseline, FAST participants will show greater reduction in head acceleration than OEP participants immediately post-training. The second part of the hypothesis postulates that compared to baseline, FAST participants will show greater reduction in head acceleration than OEP participants at three months post-training. Information will be collected on upper limb impact by utilizing conformal sensors during falls.
Number of adverse events
Time frame: AEs and SAEs will be monitored through participant involvement of the study, approximately five months.
Any adverse events (AEs) and serious adverse events (SAEs) will be recorded on the Council for International Organizations of Medical Sciences' CIOMS-E2A form by the researchers. The definition of adverse event and serious adverse events will follow that of the International Council for Harmonization.
2 secondary outcomes
The number of head impacts
Time frame: The outcome will be measured during the baseline, one-week post-intervention, and three-months post-intervention.
The movement strategy of falls
Time frame: The trunk angle, knee angle and trunk rotation of each fall will be assessed at all assessments (baseline, one-week post-intervention, and 3-month follow-up).
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 6 Nov 2024.
- Derived from this study: PubMed 39394576Zanotto A, Zanotto T, Alexander NB, Sosnoff JJ. Views and experiences of older people taking part in a safe-falling training program: Lessons learned from the FAlling Safely Training (FAST) trial. BMC Geriatr. 2024 Oct 11;24(1):818. doi: 10.1186/s12877-024-05382-7.
- Derived from this study: PubMed 37122489Zanotto T, Chen L, Fang J, Bhattacharya SB, Alexander NB, Sosnoff JJ. Minimizing fall-related injuries in at-risk older adults: The falling safely training (FAST) study protocol. Contemp Clin Trials Commun. 2023 Apr 11;33:101133. doi: 10.1016/j.conctc.2023.101133. eCollection 2023 Jun.
- Individual participant dataSharing planned: No
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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.
Jacob Sosnoff, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAST Program and Otago Exercise Program in people with Fall Injury and Fall Patients, run by University of Kansas Medical Center at 1 site in United States.
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 5 inclusion and 11 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 6 Nov 2024. 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 United States. 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. 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?
Physical discomfort related to the intervention (time frame: The physical discomfort scale will be utilized through the participant's involvement in the study, approximately five months.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05260034, which also lists 2 linked publications.
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 6 Nov 2024.