Clinical trial NCT05625828: Evaluation of the Effects of a Cognitive-Motor Fall Prevention Program on Fall Risk Factors
Official title: Evaluation of the Effects of a Cognitive-Motor Fall Prevention Program "SILVER XIII - EQUILIBRE" on Fall Risk Factors: Functional Abilities and Executive Functions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Accidental Falls
Aging
Mild Cognitive Impairment
Keywords: Dual-Task
Physical Activity
Prevention
Lead sponsor: EZUS-LYON 1
Sponsor class: OTHER
Collaborators: name: Laboratoire Interuniversitaire de Biologie de la Motricité
name: Centre Hospitalier de Roanne
First posted: 2022-11-23
Enrollment: 176
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Trail Making Test part A and B scores at Week 12 after intervention
timeFrame: Week 1 and Week 12
measure: Change of Stroop Test Victoria version scores at Week 12 after intervention
timeFrame: Week 1 and Week 12
measure: Change of walking speed at Week 12 after intervention
timeFrame: Week 1 and Week 12
Secondary outcomes:
measure: Change of Choice Stepping Reaction Time at Week 12 after intervention
timeFrame: Week 1 and Week 12
measure: Change of 30 second sit to stand test score at Week 12 after intervention
timeFrame: Week 1 and Week 12
measure: Change of 2 minutes step in place test at Week 12 after intervention
timeFrame: Week 1 and Week 12
measure: Change of one leg standing position time at Week 12 after intervention
timeFrame: Week 1 and Week 12
measure: Change of dual-task walking speed at Week 12 after intervention
timeFrame: Week 1 and Week 12
measure: Change in the walking trail making test outcomes at Week 12 after intervention
timeFrame: Week 1 and Week 12
measure: Change in fall rate at Week 36 after intervention
timeFrame: From Week 12 to Week 36
measure: Global cognition score at Week 1
timeFrame: Week 1
measure: Fall Risk score at Week 1
timeFrame: Week 1
measure: Common physical activity at Week 1
timeFrame: Week 1
measure: Sedentary behaviors at Week 1
timeFrame: Week 1
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: Laboratoire Inter-universitaire de Biologie de la Motricité, UR7424
state: Rhône
Study officials:
affiliation: Centre Hospitalier de Roanne
name: Xavier Fabre, MD
role: STUDY_DIRECTOR
affiliation: Laboratoire Inter-universitaire de Biologie de la Motricité, UR7424
name: Pascal Chabaud, PhD
role: STUDY_DIRECTOR
affiliation: Laboratoire Inter-universitaire de Biologie de la motricité, UR7424
name: Rafael Mauti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.