Minimizing Fall-Related Injury in Older Adults: a Motor Learning Approach

NCT ID: NCT05260034

Last Updated: 2024-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-18

Study Completion Date

2024-04-05

Brief Summary

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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

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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

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Fall Injury Fall Patients Mobility Limitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
In the current study, participants and intervention trainers are unmasked to the treatment and know which group they are working on. Only the assessor will be masked to the groups of participants.

Study Groups

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Otago Group

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).

Group Type ACTIVE_COMPARATOR

Otago Exercise Program

Intervention Type OTHER

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.

FAST Group

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.

Group Type EXPERIMENTAL

FAST Program

Intervention Type OTHER

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.

Interventions

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FAST Program

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.

Intervention Type OTHER

Otago Exercise Program

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacob Sosnoff, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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Emma Eells

Kansas City, Kansas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39394576 (View on PubMed)

Zanotto 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.

Reference Type DERIVED
PMID: 37122489 (View on PubMed)

Other Identifiers

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R21AG073892

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00147362

Identifier Type: -

Identifier Source: org_study_id

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