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Musculoskeletal DiseasesReabFallsNCT06175871

New Clinical Rehabilitation Approach for the Management of Falls Risks

A study testing OTAGO exercises in people with Musculoskeletal Diseases and Chronic Disease, run by Université du Québec à Chicoutimi at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Accidental falls in older adults are one of the world's major pubic health problem, because of their strong association with injuries and mortality rates. In Quebec, falls are responsible for a high rate of hospitalization (more than 1800 emergency department visits every day) and deaths (more than 10,000 in recent… Read more about this study

Who is it for?
Ages 65 to 99 years
What is being tested?
OTAGO exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteCanada
Study dates
1 Jul 2024to 1 Dec 2025
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 to 99 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Admitted to La Baie Hospital rehabilitation services; or
  • Admitted to the waiting list for geriatric services at La Baie Hospital; or
  • Older adults from the communityé
  • Age 65 and over
  • Able-bodied adult with minimal autonomy to perform fall-prevention tests and exercises.
  • Have at least one neuro-musculo-skeletal disorders and risk of falls

Who cannot join

  • Cancer
  • Red flags (infection, tumor, etc.)
  • Severe psychiatric disorders
  • Palliative care
  • Congenital spinal deformity (spondylolysis, intervertebral fusions)
  • Severe systemic syndromes or diseases that may prevent tests and exercises from being performed.
  • Stroke - very acute phase (1 week) and this until medial hemodynamic stability.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Rubens da Silva

    Saguenay, Quebec, G7H 2B1

Other trials in Canada

About this study

Official title: Development of a New Clinical Rehabilitation Approach for the Management of Elderly People With a Neuromusculoskeletal Disorder and a Risk of Falls: a Partnership Project Between UQAC and the Specialized Geriatric Services of CIUSSS-SLSJ

Accidental falls in older adults are one of the world's major pubic health problem, because of their strong association with injuries and mortality rates. In Quebec, falls are responsible for a high rate of hospitalization (more than 1800 emergency department visits every day) and deaths (more than 10,000 in recent years). Preventing falls is therefore a key mission for health professionals. This research program aims to develop a new clinical approach to the rehabilitation management of the older with a neuro-musculoskeletal disorder and a risk of falling. This program is part of a new partnership project between UQAC and specialized geriatric services at the CIUSSS Saguenay-Lac-St-Jean (La Baie site). These geriatric services admit more than 400 new patients per year, representing a large pool of participants for the new program's development. Specifically, this program has 4 phases: 1) Create a clinical profile of patients in rehabilitation care from specialized geriatric services (ex: reasons for consultation, neuro-musculoskeletal disorders, rates and causes of falls, etc.); 2) to diagnose functional deficits of these patients on different dimensions of functional and physical evaluations, using standardized tests and high-tech instruments (ex: platform of force); 3) determine the effectiveness of a new exercise intervention program (OTAGO) for falls prevention; and 4) Measure client and professional team satisfaction as well as long-term impact of this new approach used to prevent falls. The most significant impact of this new program will be to reduce public health expenditure for care of older adults with balance disorder and risk for falls; and therefore, be implanted in other CIUSSS institutions from Quebec.

Read the detailed description

This research program on aging to create Living Lab Sag aims at maintaining older adult's full individual and collective abilities in the Saguenay-Lac-Saint-Jean (SLSJ) region. The need for innovation and creativity aims at optimizing independence, whether for mobility, the ability to take charge of one's health, to remain at home, to have access to services, and to prevent falls in a frail and aging population. Thus, this program includes expert investigators in the areas of health, engineering and computer science, aging, neuropsychology, geriatrics, and rehabilitation/prevention within a multidisciplinary work approach for durable health for older adults in Saguenay. Living Lab Sag will be implemented based on an enriched research program, approved by the CIUSSS SLSJ (CER# 2019-008) and entitled: Development of a new clinical approach in rehabilitation for the care of older adults with a neuro-musculo-skeletal disorder and a risk of falling: Project in partnership between UQAC and the specialized geriatrics services of the CIUSSS-SLSJ. Canada census reports clearly show the demographic aging of the local population. It is predicted that people 65 years and older will comprise about 24% of the population in 2036, in Canada and Quebec. In parallel with this demographic phenomenon, 50% of Canadians live with at least one chronic disability that is often associated with advanced age, as well as with different neurological, orthopedic and cardiopulmonary degenerative diseases. Some diseases affecting the neuro-musculo-skeletal system will lead to physical disability and to a significant functional limitation in terms of balance, mobility and walking and, consequently, to an increase in the risk of falling. Falls have a significant financial effect on healthcare services. Every year, in Quebec, approximately 1/3 of people aged 65 and over will fall and, sadly, some data suggest that 424,000 people will die, worldwide, because of a fall. The present scenario also shows the importance of developing strategies to reduce the weight of falls on the healthcare system, such as the creation of Living Lab Sag where the older adults will be at the heart of the situation. With team's experience in the area, one strategy among others is the early identification of physical-functional factors leading to a fall, despite the presence of other associated extrinsic factors that are also associated with the fall (i.e., multifactor phenomenon). This identification can be realized through neurophysiological measures from valid and reliable biological signals in rehabilitation, that will help determine the neuromuscular responses associated to the level of physical frailty of the individual and his/her fall risk. However, geriatric services in general don't often have access to high-end screening tools that permit an early detection of balance problems and fall risk. Within an innovative action plan, our research program, in partnership with specialized geriatric services and researchers aims to determine the efficiency of new evaluation and intervention methods for the health of the older adults. Since 2019, this programm integrate new measures using various high-end equipment to capture biological signals enabling to perform research with patients from Hospital and patients from Parkinson Association and community local. The mission of this program is to build a new paradigm for this site while being a reference to evaluate balance/mobility and walking problems, better screen frail older adults who are at risk of falling and direct then to personalized therapy. At this time, this work will develop a longitudinal intervention study using OTAGO (PEO) exercise program. The name "OTAGO" is not an acronym, as "Otago" is a region of New Zealand located southwest of the southern island. PEO is defined by a reeducation program for strength and balance at home (or in a rehabilitation center), that is personalized, and based on conclusive data. The PEO was developed by a geriatrician (Dr. Campbell) and his team of physiotherapists in 1997, after many years of research, to identify the risks of falling and the potential interventions that could reduce these risks. The program exists worldwide but has never been tested in Québec. Although there are different fall prevention programs, conclusive data show the more frequent use of OTAGO because of its efficiency to reduce the risk of death and the incidence rate of falls over a period of one year in an aging population. This program also reduces falls by 25% according to conclusive data, which no other program in Québec and in rural areas has demonstrated until now. Finally, this program can be a cost-effective intervention for the healthcare system by reducing expenses associated to falls in rural areas, and in particular for patients in La Baie Hospital. Already used in Australia and the United States, we have yet to determine its effects in the Saguenay area. The goal is to test and show its efficiency for the fist time in the area by a random clinical trial in La Baie Hospital. This step will make it possible to advance our research program on the effective intervention plan to reduce future public healthcare expenses related to falls. The aim of this study will thus be to evaluate if the PEO, when adapted to La Baie geriatric services, is superior to conventional therapy to improve parameters of walking, balance, muscle activation, postural trunk control, mobility, force, endurance and perception of symptoms related to pain, function, fall risk and, consequently, quality of life (wellbeing), volume of medication and expenses associated to fall. In other step, the purpose is also evaluate the effect of carrying out the OTAGO exercises in an outdoor and nature modality during a feasibility study to see the impact of nature on the functional abilities of older people with neuromusculoskeletal disorders (ex. Parkinson disease).

Being tested
OTAGO exercises
Keywords
Aging, Rehabilitation, Postural control, Falls, Biomechanics, Technology innovative, Prevention, Mobility
Medical subject headings
Musculoskeletal Diseases, Chronic Disease, Low Back Pain, Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OTAGO exercisesOther

    Also called plein air et nature exercises

    Exercices for improvement postural control and mobility and decrease falls risks

Study groups in NCT06175871
Study groupRoleWhat they receive
Otago exercisesExperimentalOTAGO program - based on very specific exercises for balance, force, and muscular endurance as well as on education about the risk of falling. The program is considered as "home care" (exercises to be done at home) but will be done as a group and with supervision, at CIUSSS or from outdoor and nature intervention (recreactional parks). OTAGO session lasts for 30-40 minutes and will be done twice a week at sites with progression. The program is comprised of 5 muscle strengthening exercises and 12 postural balance exercises. Participants will also be invited to walk 2 times per week for 30 minutes (can be divided into shorter periods, for example 3 blocs of 10 minutes) from outdoor sites or recrative parks. According to each person's strength and mobility, exercises will be increased with the use of free weights (for example during squats) and/or by increasing the number of repetitions. Total duration of the program will be 3 months (i.e., a duration adapted to the site).
Receives: Other: OTAGO exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postural control

    Measures of center of pressure (COP) from plateform of force during different balance tasks

    Measured: change from baseline at 8 to 12 weeks

  2. Walking

    Gait parameters from GaitRite measurement

    Measured: change from baseline at 8 to 12 weeks

  3. Trunk postural control on wobble chair

    This test measures trunk postural balance during a sitting balance task on an unstable chair where only lumbar spine movements are allowed to restore balance. Briefly, the base of the chair consists of a pivot at its center and four springs that can be arranged and fixed at a distance varying between 6.0 and 21 cm from the center, allowing the system's level of stability to be varied. The system allows only forward/backward and lateral tilting.

    Measured: change from baseline at 8 to 12 weeks

  4. Machine learning-driven neuromusculoskeletal (NMS) assessment

    Adapt and integrate existing machine learning algorithms (e.g., pose detection, body reconstruction) to create an NMS assessment framework using smartphone cameras. Image and video recording will be done with three smartphone cameras, positioned on tripods at different angles to the participants. The initial use of multiple cameras is crucial for gathering multi-dimensional data and will allow us to evaluate the effect of camera angle, and the number of cameras, on the accuracy and reliability of the analyses. Various scales will be placed within the recording space, serving as reference points for future camera calibration.

    Measured: change from baseline at 8 to 12 weeks

Secondary outcomes (6)
  1. Functional mobility test: TUG

    To assess mobility. Equipment: A stopwatch. Directions: Patients wear their regular footwear and can use a walking aid, if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor.

    Measured: change from baseline at 8 to 12 weeks

  2. 30 Second Sit to Stand Test

    The 30CST is a measurement that assesses functional lower extremity strength in older adults. It is part of the Fullerton Functional Fitness Test Battery. This test was developed to overcome the floor effect of the 5 or 10 repetition sit to stand test in older adults.

    Measured: change from baseline at 8 to 12 weeks

  3. maximal isometric hand grip strength

    Jamar dynamometer to assess maximal isometric hand grip strength and frailty criteria. 3 trials of maximal contraction up 5 seconds. The best value was retained and corrected by body mass index from Fried classification.

    Measured: change from baseline at 8 to 12 weeks

  4. Walking test in 10 meters

    Walking speed executed in 10 meter walking test. 2 trials and the best value in time seconds was retained for analysis. The Fried criteria by 4,75 meters was also used to measure time in seconds from this distance (14 feet) and normalized by heigth and weigth.

    Measured: change from baseline at 8 to 12 weeks

  5. 5 times Sit-To-Stand (FTSTS)

    If the 30 second sit to stand test was not applied for some patients, we used also this test which it measures the amount of time it takes for a patient to sit and stand five times in succession with arms folded across their chest. 2 trials were applied in this test and the best time in seconds used for analysis.

    Measured: change from baseline at 8 to 12 weeks

  6. Numbers of falls

    Self-reported falls before, during and after the study

    Measured: change from baseline at 8 to 12 weeks, 6 and 12 months after

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2023
  2. Study start1 Jul 2024
  3. Primary completion31 Dec 2024
  4. Study completion1 Dec 2025

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Clinical pilot trial design
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06175871
Sponsor's protocol ID
2019-008
Acronym
ReabFalls
Status last verified
May 2026
First submitted
21 Nov 2023
Last updated
12 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fuzhong L, McAuley E, Fisher KJ, Harmer P, Chaumeton N, Wilson NL. Self-efficacy as a mediator between fear of falling and functional ability in the elderly. J Aging Health. 2002 Nov;14(4):452-66. doi: 10.1177/089826402237178.

    PubMed 12391997
  • Poquet N, Lin C. The Brief Pain Inventory (BPI). J Physiother. 2016 Jan;62(1):52. doi: 10.1016/j.jphys.2015.07.001. Epub 2015 Aug 21. No abstract available.

    PubMed 26303366
  • Barry E, Galvin R, Keogh C, Horgan F, Fahey T. Is the Timed Up and Go test a useful predictor of risk of falls in community dwelling older adults: a systematic review and meta-analysis. BMC Geriatr. 2014 Feb 1;14:14. doi: 10.1186/1471-2318-14-14.

    PubMed 24484314
  • Jiang X, Cooper J, Porter MM, Ready AE. Adoption of Canada's Physical Activity Guide and Handbook for Older Adults: impact on functional fitness and energy expenditure. Can J Appl Physiol. 2004 Aug;29(4):395-410. doi: 10.1139/h04-025.

    PubMed 15317981
  • Guideline for the prevention of falls in older persons. American Geriatrics Society, British Geriatrics Society, and American Academy of Orthopaedic Surgeons Panel on Falls Prevention. J Am Geriatr Soc. 2001 May;49(5):664-72. No abstract available.

    PubMed 11380764
  • Woolcott JC, Khan KM, Mitrovic S, Anis AH, Marra CA. The cost of fall related presentations to the ED: a prospective, in-person, patient-tracking analysis of health resource utilization. Osteoporos Int. 2012 May;23(5):1513-9. doi: 10.1007/s00198-011-1764-1. Epub 2011 Sep 3.

    PubMed 21892675
  • Oliveira MR, Vieira ER, Gil AWO, Fernandes KBP, Teixeira DC, Amorim CF, da Silva RA. One-legged stance sway of older adults with and without falls. PLoS One. 2018 Sep 17;13(9):e0203887. doi: 10.1371/journal.pone.0203887. eCollection 2018.

    PubMed 30222769
  • Vieira ER, Tappen R, Gropper SS, Severi MT, Engstrom G, de Oliveira MR, Barbosa AC, da Silva RA. Changes on Walking During Street Crossing Situations and on Dorsiflexion Strength of Older Caribbean Americans After an Exercise Program: A Pilot Study. J Aging Phys Act. 2017 Oct 1;25(4):525-532. doi: 10.1123/japa.2016-0231. Epub 2017 Sep 14.

    PubMed 28095084
  • Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

    PubMed 11253156
  • Campbell AJ, Robertson MC, Gardner MM, Norton RN, Tilyard MW, Buchner DM. Randomised controlled trial of a general practice programme of home based exercise to prevent falls in elderly women. BMJ. 1997 Oct 25;315(7115):1065-9. doi: 10.1136/bmj.315.7115.1065.

    PubMed 9366737
  • Shubert TE, Smith ML, Goto L, Jiang L, Ory MG. Otago Exercise Program in the United States: Comparison of 2 Implementation Models. Phys Ther. 2017 Feb 1;97(2):187-197. doi: 10.2522/ptj.20160236.

    PubMed 28204770
  • Thomas S, Mackintosh S, Halbert J. Does the 'Otago exercise programme' reduce mortality and falls in older adults?: a systematic review and meta-analysis. Age Ageing. 2010 Nov;39(6):681-7. doi: 10.1093/ageing/afq102. Epub 2010 Sep 4.

    PubMed 20817938
  • Derouesne C, Poitreneau J, Hugonot L, Kalafat M, Dubois B, Laurent B. [Mini-Mental State Examination:a useful method for the evaluation of the cognitive status of patients by the clinician. Consensual French version]. Presse Med. 1999 Jun 12;28(21):1141-8. French.

    PubMed 10399508
  • Jones SE, Kon SS, Canavan JL, Patel MS, Clark AL, Nolan CM, Polkey MI, Man WD. The five-repetition sit-to-stand test as a functional outcome measure in COPD. Thorax. 2013 Nov;68(11):1015-20. doi: 10.1136/thoraxjnl-2013-203576. Epub 2013 Jun 19.

    PubMed 23783372
  • da Silva RA, Vieira ER, Carvalho CE, Oliveira MR, Amorim CF, Neto EN. Age-related differences on low back pain and postural control during one-leg stance: a case-control study. Eur Spine J. 2016 Apr;25(4):1251-7. doi: 10.1007/s00586-015-4255-9. Epub 2015 Oct 1.

    PubMed 26428907

Questions about this trial

What is this clinical trial studying?

A study testing OTAGO exercises in people with Musculoskeletal Diseases and Chronic Disease, run by Université du Québec à Chicoutimi at 1 site in Canada.

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 6 inclusion and 7 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 12 May 2026. 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 Canada. 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?

Postural control (time frame: change from baseline at 8 to 12 weeks). The study lists 4 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 NCT06175871, which also lists 20 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 12 May 2026.

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