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

NCT05260034 | Completed

• 2 other identifiers: STUDY00147362R21AG073892
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Fall Injury; Fall Patients; Mobility Limitation

Keywords

Falls; Physical Therapy; Injury Prevention

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  AEs and SAEs will be monitored through participant involvement of the study, approximately five months.

Secondary Outcomes (2)

• The number of head impacts

  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 of each fall will be assessed at all assessments (baseline, one-week post-intervention, and 3-month follow-up).

Other Outcomes (1)

• Balance

  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.

Study Arms (2)

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).

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.

Other: FAST Program

Interventions

FAST Program 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.

FAST Group

Otago Exercise Program 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.

Otago Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Emma Eells

Kansas City, Kansas, 66103, United States

Location

Related Publications (2)

• 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.

  PMID: 39394576 DERIVED

• 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.

  PMID: 37122489 DERIVED

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacob Sosnoff, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: March 2, 2022
• Study Start: July 18, 2022
• Primary Completion: April 5, 2024
• Study Completion: April 5, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)