Evaluation of the Effects of a Cognitive-Motor Fall Prevention Program on Fall Risk Factors

NCT ID: NCT05625828

Last Updated: 2025-07-29

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-13

Study Completion Date

2025-10-24

Brief Summary

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The goal of this interventional study is to compare in community dwelling elderly people the effects of two physical activity programs to prevent accident falls : "SILVER XIII EQUILIBRE" program and "VIVIFRAIL" program, on several risks factors such as executive functions and functional capacities.

Participants will perform a 1 hour physical activity session during 10 weeks and effects will be measured using a multidimensional test battery. "SILVER XIII EQUILIBRE" program contains cognitive-motor exercises where participants have to perform two tasks simultaneously such as answering math questions while walking whereas "VIVIFRAIL" program contains multifactorial exercises such as walking, balance training and resistance training in single-task condition.

The main question it aims to answer is :

• Does physical activity enriched with simultaneous cognitive exercises enhances the effects ?

Detailed Description

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Falls in the elderly are a problem of increasing importance in our aging societies. Among the multiple intrinsic risk factors, if the age-induced decline of functional and locomotor capacities are recognized risk factors, impaired executive functioning is another equally important one. Thus, Mild Cognitive Impairment (MCI) - characterized by an early deficit in executive functioning but not pathological - turns out to be an independent and significant risk factor. In order to reduce the impact of this problem and thus promote "well aging", it is essential to develop effective preventive approaches on all of these risk factors. Of these, cognitive-motor fall prevention programs - based on simultaneous cognitive and motor tasks - are the most effective in reducing the rate of falls. However, since 2017, the French Rugby League Federation has been proposing such an innovative program called "SILVER XIII - EQUILIBRE" consisting of 10 one-hour sessions per week and including a majority of cognitive-motor exercises. In addition, this program also includes exercises for learning the "play the ball", a specific skill of rugby league that consist of shooting the ball with the heel and making a step forward which is close to the stepping strategy to avoid falling. Initially intended for community dwelling elderly people and non-fallers presenting a usual aging (average age = 67.6 +/- 3 years), it turns out that this program welcomes three different profiles of elderly people that we find in the literature: (1) young-aged, active people with no deficits in functional and cognitive abilities; (2) older people with optimal cognitive aging but less active (3) older people with MCI. As the effects of regular Physical Activity (PA) depend on the initial level of each individual, it could be that the effects of the "SILVER XIII - EQUILIBRE" program on both functional abilities and executive functions depend on the profile of the elderly. In order to answer the main question the effects of the "SILVER XIII EQUILIBRE" program will be compared to an active comparator : the "VIVIFRAIL" program which is a international multifactorial program to prevent falls based on walking, balance and resistance training single task exercises.

Conditions

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Accidental Falls Aging Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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SILVER XIII EQUILIBRE

Cognitive-motor 10 weeks program

Group Type EXPERIMENTAL

Cognitive-motor Physical Activity

Intervention Type BEHAVIORAL

Physical activity program that consist of 1 sessions per week during 10 weeks (from Week 2 to Week 11). Each session includes a 10 minutes warm up with light walking, 45 minutes of cognitive-motor exercises where participants have to perform two tasks consequently (for example, walking while answering math questions or throwing a ball while reverse walking) and 5 minutes of stretching exercises.

VIVIFRAIL

Multifactorial 10 weeks program

Group Type ACTIVE_COMPARATOR

Multifactorial Physical Activity

Intervention Type BEHAVIORAL

Physical activity program that consist of 1 sessions per week during 10 weeks (from Week 2 to Week 11). Each session includes a 10 minutes warm up with light walking, 45 minutes of multifactorial exercises that consists of high speed walking, resistance training and balance training in single task condition and 5 minutes of stretching exercises.

Interventions

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Cognitive-motor Physical Activity

Physical activity program that consist of 1 sessions per week during 10 weeks (from Week 2 to Week 11). Each session includes a 10 minutes warm up with light walking, 45 minutes of cognitive-motor exercises where participants have to perform two tasks consequently (for example, walking while answering math questions or throwing a ball while reverse walking) and 5 minutes of stretching exercises.

Intervention Type BEHAVIORAL

Multifactorial Physical Activity

Physical activity program that consist of 1 sessions per week during 10 weeks (from Week 2 to Week 11). Each session includes a 10 minutes warm up with light walking, 45 minutes of multifactorial exercises that consists of high speed walking, resistance training and balance training in single task condition and 5 minutes of stretching exercises.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Older people living at home
* Able to walk without technical assistance

Exclusion Criteria

* Presence of a proven major neurocognitive disorder (MOCA score \< 18)
* Patients with severe depression (Geriatric Depression Scale score \> 10)
* Body mass index (BMI) \> 35
* Diagnosed and known neurological or neurodegenerative pathology
* Having declared more than 3 falls in the pas year
* Presence of a motor disorder
* Contraindication to the practice of a physical or sporting activity
* Participation in another protocol for the prevention of falls or loss of autonomy in the last 6 months
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Laboratoire Interuniversitaire de Biologie de la Motricité

OTHER

Sponsor Role collaborator

Centre Hospitalier de Roanne

OTHER

Sponsor Role collaborator

EZUS-LYON 1

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier Fabre, MD

Role: STUDY_DIRECTOR

Centre Hospitalier de Roanne

Pascal Chabaud, PhD

Role: STUDY_DIRECTOR

Laboratoire Inter-universitaire de Biologie de la Motricité, UR7424

Rafael Mauti, MSc

Role: PRINCIPAL_INVESTIGATOR

Laboratoire Inter-universitaire de Biologie de la motricité, UR7424

Locations

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Laboratoire Inter-universitaire de Biologie de la Motricité, UR7424

Villeurbanne, Rhône, France

Site Status

Countries

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France

References

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Bayard S, Erkes J, Moroni C; College des Psychologues Cliniciens specialises en Neuropsychologie du Languedoc Roussillon (CPCN Languedoc Roussillon). Victoria Stroop Test: normative data in a sample group of older people and the study of their clinical applications in the assessment of inhibition in Alzheimer's disease. Arch Clin Neuropsychol. 2011 Nov;26(7):653-61. doi: 10.1093/arclin/acr053. Epub 2011 Aug 26.

Reference Type BACKGROUND
PMID: 21873625 (View on PubMed)

REITAN RM. The relation of the trail making test to organic brain damage. J Consult Psychol. 1955 Oct;19(5):393-4. doi: 10.1037/h0044509. No abstract available.

Reference Type BACKGROUND
PMID: 13263471 (View on PubMed)

Lord SR, Fitzpatrick RC. Choice stepping reaction time: a composite measure of falls risk in older people. J Gerontol A Biol Sci Med Sci. 2001 Oct;56(10):M627-32. doi: 10.1093/gerona/56.10.m627.

Reference Type BACKGROUND
PMID: 11584035 (View on PubMed)

Bongue B, Dupre C, Beauchet O, Rossat A, Fantino B, Colvez A. A screening tool with five risk factors was developed for fall-risk prediction in community-dwelling elderly. J Clin Epidemiol. 2011 Oct;64(10):1152-60. doi: 10.1016/j.jclinepi.2010.12.014. Epub 2011 Apr 3.

Reference Type BACKGROUND
PMID: 21463927 (View on PubMed)

Fournier J, Vuillemin A, Le Cren F. Mesure de la condition physique chez les personnes âgées. Evaluation de la condition physique des seniors : adaptation française de la batterie américaine " Senior Fitness Test ". Science & Sport. 2012; 27 : 254-259.

Reference Type BACKGROUND

De Souto Barreto, P., Ferrandez, A. M., & Saliba-Serre, B. Questionnaire d'activité physique pour les personnes âgées (QAPPA): validation d'un nouvel instrument de mesure en langue française. Science and Sports. 2011; 26(1): 11-18.

Reference Type BACKGROUND

Golubic R, May AM, Benjaminsen Borch K, Overvad K, Charles MA, Diaz MJ, Amiano P, Palli D, Valanou E, Vigl M, Franks PW, Wareham N, Ekelund U, Brage S. Validity of electronically administered Recent Physical Activity Questionnaire (RPAQ) in ten European countries. PLoS One. 2014 Mar 25;9(3):e92829. doi: 10.1371/journal.pone.0092829. eCollection 2014.

Reference Type BACKGROUND
PMID: 24667343 (View on PubMed)

Perrochon A, Kemoun G. The Walking Trail-Making Test is an early detection tool for mild cognitive impairment. Clin Interv Aging. 2014;9:111-9. doi: 10.2147/CIA.S53645. Epub 2014 Jan 7.

Reference Type BACKGROUND
PMID: 24426778 (View on PubMed)

Alexander NB, Ashton-Miller JA, Giordani B, Guire K, Schultz AB. Age differences in timed accurate stepping with increasing cognitive and visual demand: a walking trail making test. J Gerontol A Biol Sci Med Sci. 2005 Dec;60(12):1558-62. doi: 10.1093/gerona/60.12.1558.

Reference Type BACKGROUND
PMID: 16424288 (View on PubMed)

Other Identifiers

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005B2022

Identifier Type: -

Identifier Source: org_study_id

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