Clinical trial NCT05260034: Minimizing Fall-Related Injury in Older Adults: a Motor Learning Approach
Official title: Minimizing Fall-Related Injury in Older Adults: a Motor Learning Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall Injury
Fall Patients
Mobility Limitation
Keywords: Falls
Physical Therapy
Injury Prevention
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-03-02
Enrollment: 33
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Physical discomfort related to the intervention
timeFrame: The physical discomfort scale will be utilized through the participant's involvement in the study, approximately five months.
measure: Participant ability to master the intervention
timeFrame: Feasibility will be measured during the intervention, which will last four weeks.
measure: Determining FAST efficacy in reducing hip impact force, versus Otago Exercise Program (OEP).
timeFrame: The outcome will measured at the baseline, one-week post-intervention, and three-months post-intervention.
measure: Determining FAST efficacy in reducing head acceleration, versus Otago Exercise Program (OEP).
timeFrame: The outcome will be measured during the baseline, one-week post-intervention, and three-months post-intervention.
measure: Number of adverse events
timeFrame: AEs and SAEs will be monitored through participant involvement of the study, approximately five months.
Secondary outcomes:
measure: The number of head impacts
timeFrame: The outcome will be measured during the baseline, one-week post-intervention, and three-months post-intervention.
measure: The movement strategy of falls
timeFrame: 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).
Other outcomes:
measure: Balance
timeFrame: BBS will be assessed at all assessments (baseline, one-week post-intervention, and 3-month follow-up). Each assessment will last about 1.5 hours.
Locations:
city: Kansas City
country: United States
facility: Emma Eells
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jacob Sosnoff, PhD
role: PRINCIPAL_INVESTIGATOR
References: