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

Evaluation of the Effects of a Cognitive-Motor Fall Prevention Program "SILVER XIII - EQUILIBRE" on Fall Risk Factors: Functional Abilities and Executive Functions

Sponsors

Lead Sponsor: EZUS-LYON 1

Collaborator: Hospices Civils de Lyon
Laboratoire Interuniversitaire de Biologie de la Motricité

Source EZUS-LYON 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 ?

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 technical gesture 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 Old person. 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.

Overall Status Recruiting
Start Date 2022-09-13
Completion Date 2025-12-01
Primary Completion Date 2025-04-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change of Trail Making Test part A and B scores at Week 12 after intervention Week 1 and Week 12
Change of Stroop Test Victoria version scores at Week 12 after intervention Week 1 and Week 12
Change of walking speed at Week 12 after intervention Week 1 and Week 12
Secondary Outcome
Measure Time Frame
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
Change in fall rate at Week 36 after intervention From Week 12 to Week 36
Global cognition score at Week 1 Week 1
Fall Risk score at Week 1 Week 1
Common physical activity at Week 1 Week 1
Sedentary behaviors at Week 1 Week 1
Enrollment 172
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Cognitive-motor Physical Activity

Description: 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.

Arm Group Label: SILVER XIII EQUILIBRE

Intervention Type: Behavioral

Intervention Name: Multifactorial Physical Activity

Description: 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.

Arm Group Label: VIVIFRAIL

Eligibility

Criteria:

Inclusion Criteria: - Older people living at home - Able to walk without technical assistance - Having declared at most one fall in the year Exclusion Criteria: - Presence of a proven major neurocognitive disorder (MOCA score < 20) - Patients with depression (Geriatric Depression Scale score > 5) - Body mass index (BMI) > 30 - Diagnosed and known neurological or neurodegenerative pathology - 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

Gender:

All

Minimum Age:

65 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: Pierre KROLAK-SALMON, MD

Phone: +33 (0) 472 433 113

Email: [email protected]

Location
Facility: Status: Contact: Hôpital des Charpennes Pierre KROLAK-SALMON, MD +33 (0) 472 433 113 [email protected]
Location Countries

France

Verification Date

2022-11-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: SILVER XIII EQUILIBRE

Type: Experimental

Description: Cognitive-motor 10 weeks program

Label: VIVIFRAIL

Type: Active Comparator

Description: Multifactorial 10 weeks program

Acronym 13EVAL
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Single (Participant)

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