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Active, not recruiting Not applicable

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

NCT05625828 · tracked via the Priya Life Science France tracker
Sponsor
EZUS-LYON 1
Phase
Not applicable
Started
2022-09-13
Last updated
2025-07-29

Condition(s) studied

Accidental FallsAgingMild Cognitive Impairment

Investigational drug(s) / intervention(s)

Cognitive-motor Physical ActivityMultifactorial Physical Activity

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.

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.

Study 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 ?

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
Accepted
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 outcome measure(s)

  • Change of Trail Making Test part A and B scores at Week 12 after intervention — Week 1 and Week 12
    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.
  • Change of Stroop Test Victoria version scores at Week 12 after intervention — Week 1 and Week 12
    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.
  • Change of walking speed at Week 12 after intervention — Week 1 and Week 12
    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.

Trial sites (1)

FacilityCityRegionStatus
Laboratoire Inter-universitaire de Biologie de la Motricité, UR7424 Villeurbanne Rhône
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05625828 on ClinicalTrials.gov ↗ ← All trials in France