NCT04844047

Brief Summary

Falls are the leading cause of injury hospitalization for seniors across Saskatchewan and addressing the underlying causes is a provincial health priority. Older women are more vulnerable to the most common fall-related injuries (upper body) during forward falling while walking. Exercise programs designed to improve balance and strength can reduce fall risk but it is not known if specific exercises targeted to upper body strength and agility can improve chances for safe landing when a fall is inevitable. The investigators have developed such a program, Fall Arrest Strategy Training (FAST) and successfully piloted the feasibility of the exercises to be included in a standard fall prevention program. FAST is meant to increase arm strength, reaction time, trunk control, and teach better landing techniques. The potential efficacy of such an intervention to improve landing capacity has not been studied in older women. Thirty-two women age 60 years or older will be randomly assigned to either FAST or a Standard Exercise group. Half will do standard exercises targeting balance, mobility and lower extremity strength; the other half will do the same exercises with the addition of FAST. Both groups will exercise twice per week for 12 weeks. Participants will be tested before and after for arm strength, reaction time, balance, mobility and the ability to control body descent (absorb energy) using a technique we developed in our lab. While in a safety harness, participants will simulate a forward fall onto a platform that measures energy during impact. While completely preventing falls is not possible, this study will help the investigators learn if simple exercises like FAST combined with balance training can decrease fall risk AND reduce the risk of serious injury when a fall is unavoidable. It will help address the growing personal and societal cost of fall-related injury. This study will also inform future research targeted to include a large-scale trial evaluating the impact and implementation of FAST training in older adults across the spectrum of care and development of a computer simulation model to determine which factors are most important for reducing the risk of fall-related injury.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 24, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2017

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

8 months

First QC Date

March 8, 2021

Last Update Submit

April 12, 2021

Conditions

Keywords

fall riskolder adultinjury prevention

Outcome Measures

Primary Outcomes (16)

  • UE Strength - Isometric

    Measured with a hand-held dynamometer; mean of three trials for shoulder abduction, shoulder flexion and elbow extension

    12 weeks

  • UE Strength - Grip

    Measured with a dynamometer; participant in sitting, standardized elbow flexion position and handle position, gripping maximum exertion; mean of three trials for shoulder abduction, shoulder flexion and elbow extension

    12 weeks

  • UE Strength - Isometric Push-off Test

    Measured with a hand-held dynamometer for grip strength with the handle inverted and stabilized on a table top. Participant pushes downward in a standing position; mean of 3 trials used

    12 weeks

  • UE Strength - Isokinetic Concentric and Eccentric

    Using a protocol developed in the investigators' lab, with the Humac Norm isokinetic dynamometer. An upper extremity pushing motion of primarily elbow extension measuring maximal force for concentric and eccentric motion. Mean of three trials used

    12 weeks

  • UE Mobility

    Shoulder Extension and Wrist Extension Active Range of Motion with passive overpressure measure with a manual goniometer in a sitting position

    12 weeks

  • UE Response Time

    Time from the start of an auditory cue to lift hands from a position standing with arms at side of body to the first touch on a force from auditory cue to touching a forceplate at shoulder level. Mean of three trials for right, left and both hands together used.

    12 weeks

  • Balance - One Leg Standing

    Timed ability to stand on one leg with no support, up to 60 seconds. Two trials on each leg

    12 weeks

  • Balance - Tandem Standing

    This is a standard test first described by Hile et al (2012) where the participant tries standing in a tandem position, one foot in front of the other first with and then without support for up to 30 seconds without support. Scored on a scale of 5, with maximum score of 5 meaning standing without support for full 30 seconds

    12 weeks

  • Self Report Fall Risk - FROP-Com

    Fall Risk for Older People living in the Community (National Aging Research Institute, 2012 http://www.mednwh.unimelb.edu.au/nari\_tools/nari\_tools\_falls.html) measures fall risk in 13 categories, for a total possible score of 60 (higher risk)

    12 weeks

  • Self Report Balance Confidence

    Activities Balance Confidence Scale (ABC; Powell \& Myers 1995) rating of confidence for 16 day to day functional tasks on a scale 0 - 100; mean of 16 items used as total score

    12 weeks

  • Sit to Stand Test

    Number of full sit to stand movements completed within 30 seconds with arms crossed. One practice followed by actual test

    12 weeks

  • Timed Up and Go Test (TUG)

    Timed test to stand up from a chair, walk 3 meters, turn to chair and sit down. One practice trial, followed by one timed test (Podsiadlo \& Richardson 1991)

    12 weeks

  • Ground Reaction Force

    Forward Descent and Landing Apparatus used to measure a controlled and unexpected release onto outstretched hands (simulated forward fall). Bilateral force platforms recorded ground reaction forces as participants performed a controlled descent with body at an angle 30 degrees from vertical, and then in an unexpected release while tethered to the ceiling, shoulders in 90 degrees of flexion and hands just hovering above force plate. Mean of 3 trials.

    12 weeks

  • Elbow ROM during simulated forward descent

    Forward Descent and Landing Apparatus used to measure a controlled and unexpected release onto outstretched hands (simulated forward fall). An eight camera motion capture system collected 3D upper extremity kinematics. Maximal elbow ROM was measured as participants performed a controlled descent with body at an angle 30 degrees from vertical, and then in an unexpected release while tethered to the ceiling, shoulders in 90 degrees of flexion and hands just hovering above force plate. Mean of 3 trials.

    12 weeks

  • Peak elbow moment and elbow stiffness during simulated forward descent

    Forward Descent and Landing Apparatus used to measure a controlled and unexpected release onto outstretched hands (simulated forward fall). An eight camera motion capture system collected 3D upper extremity kinematics. Elbow moments and stiffness values were calculated, normalized to height and body weight. Participants performed a controlled descent with body at an angle 30 degrees from vertical, and then in an unexpected release while tethered to the ceiling, shoulders in 90 degrees of flexion and hands just hovering above force plate. Mean of 3 trials.

    12 weeks

  • Energy Absorption during simulated forward descent

    Forward Descent and Landing Apparatus used to measure a controlled and unexpected release onto outstretched hands (simulated forward fall). An eight camera motion capture system collected 3D upper extremity kinematics. Energy absorption was calculated calculated using the total ground reaction force and the movement of the shoulders as a measure of the vertical displacement of the body, normalized to height and body weight. Participants performed a controlled descent with body at an angle 30 degrees from vertical, and then in an unexpected release while tethered to the ceiling, shoulders in 90 degrees of flexion and hands just hovering above force plate. Mean of 3 trials.

    12 weeks

Secondary Outcomes (2)

  • Falls

    64 weeks

  • Muscle Activity

    12 weeks

Study Arms (2)

FAST

ACTIVE COMPARATOR

Twice per week exercise program, 45 minutes duration for 12 weeks conducted in the community. Participants attended a 30-minute fall prevention education session once per week. FAST followed the same principles as Standard, with the addition of the following goals: 1) Increase UE strength (shoulder girdle/arm) utilizing both concentric and eccentric contractions, 2) Improve trunk and neck postural control during slow and fast body motions, 3) Optimize forward descent strategies via practice of quick response reaching, landing and controlled descent with hands on the wall or on the floor as able. Training progression for strength and body control included increasing the distance standing from the wall, progressing to one arm descents, increasing reps and speed and moving to greater gravity and body weight resistance such as hands and knees position on the floor as able. Quick movement practice targeted unexpected reaching activities, balloon and ball toss

Other: Exercise

Standard

PLACEBO COMPARATOR

Twice per week exercise program, 45 minutes duration for 12 weeks conducted in a community site (assisted living residence). Participants also attended a 3o minute fall prevention education session once per week. The Standard intervention consisted of a fall prevention exercise program designed for community-dwelling older adults. Exercises focussed on balance, leg strength, walking and mobility exercises designed to decrease fall risk.

Other: Exercise

Interventions

refer to arm descriptors

Also known as: FAST
FAST

Eligibility Criteria

Age60 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf identification as female is inclusion criteria
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Women aged 60 years or older living in the community.

You may not qualify if:

  • Any recent upper body (hand, wrist, shoulder, trunk, neck) injury or painful joint problem that limited day to day activities or resulted in pain on a daily basis,
  • A prior distal radius fracture in the past 2 years,
  • Any fracture in the past year, or multiple fractures of the wrist or forearm,
  • Any history of UE neurological problems (i.e. Stroke, Multiple Sclerosis, Parkinson's Disease, Reflex Neuropathy),
  • Any cardio-vascular problems that would contradict UE strength testing or training,
  • Any signs of severe cognitive impairment or
  • Unable to safely ambulate independently (with or without a walking aid) in the community.
  • A medical and demographic screening questionnaire as well as the Mini-Cog (Borson et al, 2000) were used to determine eligibility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • DeGoede KM, Ashton-Miller JA. Fall arrest strategy affects peak hand impact force in a forward fall. J Biomech. 2002 Jun;35(6):843-8. doi: 10.1016/s0021-9290(02)00011-8.

    PMID: 12021005BACKGROUND
  • DeGoede KM, Ashton-Miller JA. Biomechanical simulations of forward fall arrests: effects of upper extremity arrest strategy, gender and aging-related declines in muscle strength. J Biomech. 2003 Mar;36(3):413-20. doi: 10.1016/s0021-9290(02)00396-2.

    PMID: 12594989BACKGROUND
  • Borson S, Scanlan J, Brush M, Vitaliano P, Dokmak A. The mini-cog: a cognitive 'vital signs' measure for dementia screening in multi-lingual elderly. Int J Geriatr Psychiatry. 2000 Nov;15(11):1021-7. doi: 10.1002/1099-1166(200011)15:113.0.co;2-6.

    PMID: 11113982BACKGROUND
  • Sran MM, Stotz PJ, Normandin SC, Robinovitch SN. Age differences in energy absorption in the upper extremity during a descent movement: implications for arresting a fall. J Gerontol A Biol Sci Med Sci. 2010 Mar;65(3):312-7. doi: 10.1093/gerona/glp153. Epub 2009 Oct 27.

    PMID: 19861641BACKGROUND
  • Lee Y, Ashton-Miller JA. The effects of gender, level of co-contraction, and initial angle on elbow extensor muscle stiffness and damping under a step increase in elbow flexion moment. Ann Biomed Eng. 2011 Oct;39(10):2542-9. doi: 10.1007/s10439-011-0308-3. Epub 2011 Apr 12.

    PMID: 21484509BACKGROUND
  • Lo J, McCabe GN, DeGoede KM, Okuizumi H, Ashton-Miller JA. On reducing hand impact force in forward falls: results of a brief intervention in young males. Clin Biomech (Bristol). 2003 Oct;18(8):730-6. doi: 10.1016/s0268-0033(03)00124-4.

    PMID: 12957559BACKGROUND
  • Maki BE, McIlroy WE. Control of rapid limb movements for balance recovery: age-related changes and implications for fall prevention. Age Ageing. 2006 Sep;35 Suppl 2:ii12-ii18. doi: 10.1093/ageing/afl078.

    PMID: 16926197BACKGROUND
  • Public Health Agency of Canada. Seniors' Falls in Canada. 2nd Report. 2014; www.phac-aspc.gc.ca/seniors-aines [On-line].

    BACKGROUND
  • Schonnop R, Yang Y, Feldman F, Robinson E, Loughin M, Robinovitch SN. Prevalence of and factors associated with head impact during falls in older adults in long-term care. CMAJ. 2013 Nov 19;185(17):E803-10. doi: 10.1503/cmaj.130498. Epub 2013 Oct 7.

    PMID: 24101612BACKGROUND
  • Sherrington C, Whitney JC, Lord SR, Herbert RD, Cumming RG, Close JC. Effective exercise for the prevention of falls: a systematic review and meta-analysis. J Am Geriatr Soc. 2008 Dec;56(12):2234-43. doi: 10.1111/j.1532-5415.2008.02014.x.

    PMID: 19093923BACKGROUND
  • Chiu J, Robinovitch SN. Prediction of upper extremity impact forces during falls on the outstretched hand. J Biomech. 1998 Dec;31(12):1169-76. doi: 10.1016/s0021-9290(98)00137-7.

    PMID: 9882050BACKGROUND
  • Arnold CM, Walker-Johnston J, Lanovaz JL, Lattimer LJ. Does Fall Arrest Strategy Training Added to a Fall Prevention Programme Improve Balance, Strength, and Agility in Older Women? A Pilot Study. Physiother Can. 2017;69(4):323-332. doi: 10.3138/ptc.2016-27EP.

    PMID: 30369700BACKGROUND
  • Lattimer LJ, Lanovaz JL, Farthing JP, Madill S, Kim S, Robinovitch S, Arnold C. Female Age-Related Differences in Biomechanics and Muscle Activity During Descents on the Outstretched Arms. J Aging Phys Act. 2017 Jul;25(3):474-481. doi: 10.1123/japa.2016-0102. Epub 2017 Jun 28.

    PMID: 28095094BACKGROUND
  • Lattimer LJ, Lanovaz JL, Farthing JP, Madill S, Kim SY, Robinovitch S, Arnold CM. Biomechanical and physiological age differences in a simulated forward fall on outstretched hands in women. Clin Biomech (Bristol). 2018 Feb;52:102-108. doi: 10.1016/j.clinbiomech.2018.01.018. Epub 2018 Feb 3.

    PMID: 29407858BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Cathy Arnold, PhD

    School Of Rehabilitation Science, University Of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessors were blinded to intervention
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 8, 2021

First Posted

April 14, 2021

Study Start

August 24, 2016

Primary Completion

April 18, 2017

Study Completion

April 18, 2017

Last Updated

April 14, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Aggregate data will be disseminated. Participants will receive aggregate summary of findings and confidential individual information as requested