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

NCT05625828 | Active Not Recruiting

• 1 other identifier: 005B2022
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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 ?

Conditions

Accidental Falls; Aging; Mild Cognitive Impairment

Keywords

Dual-Task; Physical Activity; Prevention

Outcome Measures

Primary Outcomes (3)

• Change of Trail Making Test part A and B scores at Week 12 after intervention

  Participants will be asked to perform the Trail Making Test part A and B (Reitan, 1958) following the instructions of the evaluator. It consist of connecting by making pencil lines 25 encircled numbers randomly arranged on a page in proper order (part A) and 25 encircled numbers and letters in alternating order (part B). A sample page including only 8 circles is made for training just before each 25 circle test page. Measurements will take place one week before the first session (Week 1) and one week after the last session (Week 12). Execution time will be measured in seconds.

  Week 1 and Week 12

• Change of Stroop Test Victoria version scores at Week 12 after intervention

  Participants will be asked to perform the Stroop Test Victoria version (Bayard, 2011) following the instructions of the evaluator. It consist of three pages each containing 6 lines of 4 items and each page includes an additional line for training. In the page 1 participant has to tell the color of 4 dots printed in color ink in left to right order and line by line ; in the page two 4 neutral words are printed in color ink and participants has to tell the color of the ink in the same order ; in page three 4 color words are printed in color ink and participants has to tell the color of the ink in the same order. Measurements will take place one week before the first session (Week 1) and one week after the last session (Week 12). Execution time in second and errors will be measured.

  Week 1 and Week 12

• Change of walking speed at Week 12 after intervention

  Participants will perform a 6 meters gait measurement where they have to walk at self pace on a 10 meters corridor and time in second will be measured on 6 meters using photoelectric sensors. The first 2 meters are for reaching the pace and last 2 meters are to stop. Measurements will take place one week before the first session (Week 1) and one week after the last session (Week 12). Spontaneous gait speed will be measured in meters per second.

  Week 1 and Week 12

Secondary Outcomes (11)

• Change of Choice Stepping Reaction Time at Week 12 after intervention

  Week 1 and Week 12

• Change of 30 second sit to stand test score at Week 12 after intervention

  Week 1 and Week 12

• Change of 2 minutes step in place test at Week 12 after intervention

  Week 1 and Week 12

• Change of one leg standing position time at Week 12 after intervention

  Week 1 and Week 12

• Change of dual-task walking speed at Week 12 after intervention

  Week 1 and Week 12

Study Arms (2)

SILVER XIII EQUILIBRE

EXPERIMENTAL

Cognitive-motor 10 weeks program

Behavioral: Cognitive-motor Physical Activity

VIVIFRAIL

ACTIVE COMPARATOR

Multifactorial 10 weeks program

Behavioral: Multifactorial Physical Activity

Interventions

Cognitive-motor Physical Activity 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.

SILVER XIII EQUILIBRE

Multifactorial Physical Activity 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.

VIVIFRAIL

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• EZUS-LYON 1: lead
• Laboratoire Interuniversitaire de Biologie de la Motricité: collaborator
• Centre Hospitalier de Roanne: collaborator

Study Sites (1)

Laboratoire Inter-universitaire de Biologie de la Motricité, UR7424

Villeurbanne, Rhône, 69100, France

Location

Related Publications (9)

• 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.

  PMID: 21873625 BACKGROUND

• 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.

  PMID: 13263471 BACKGROUND

• 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.

  PMID: 11584035 BACKGROUND

• 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.

  PMID: 21463927 BACKGROUND

• 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.

  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.

  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.

  PMID: 24667343 BACKGROUND

• 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.

  PMID: 24426778 BACKGROUND

• 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.

  PMID: 16424288 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• Xavier Fabre, MD

  Centre Hospitalier de Roanne

  STUDY DIRECTOR

• Pascal Chabaud, PhD

  Laboratoire Inter-universitaire de Biologie de la Motricité, UR7424

  STUDY DIRECTOR

• Rafael Mauti, MSc

  Laboratoire Inter-universitaire de Biologie de la motricité, UR7424

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 23, 2022
• Study Start: September 13, 2022
• Primary Completion: April 24, 2025
• Study Completion: October 24, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)