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

Study Overview
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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 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.

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

Conditions
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Accidental Falls, Aging, Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Cognitive-motor Physical Activity
* Behavioral: Multifactorial Physical Activity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SILVER XIII EQUILIBRE<br>Cognitive-motor 10 weeks program | Behavioral: Cognitive-motor Physical Activity<br>* 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.<br>|
| Active Comparator: VIVIFRAIL<br>Multifactorial 10 weeks program | Behavioral: Multifactorial Physical Activity<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Choice Stepping Reaction Time at Week 12 after intervention | Participants will perform a Choice Stepping Reaction Task (Lord SR & Fitzpatrick, 2001) : Participants stand on a nonslip black platform that contained four rectangular panels, one in the front one in the back and one to the side of each foot (up, down, left and right). A computer generates a stimuli (an arrow) indicating the direction of the target the participant has to step on as fast as possible. Choice Stepping Reaction Time that consist of time between the presentation of stimuli and the foot lift will be measured in second. Measurements will take place one week before the first session (Week 1) and one week after the last session (Week 12). | Week 1 and Week 12 | 
| Change of 30 second sit to stand test score at Week 12 after intervention | This test is a part of the Senior Fitness Test assessment (Fournier et al., 2012). Participants will perform the 30 second sit to stand test, which consist of repetitively standing up from a chair as fast as possible during 30 seconds. Measurements will take place one week before the first session (Week 1) and one week after the last session (Week 12). Number of repetition will be measured. | Week 1 and Week 12 | 
| Change of 2 minutes step in place test at Week 12 after intervention | This test is a part of the Senior Fitness Test assessment (Fournier et al., 2012). Participants will perform the 2 minutes step in place test which consist of alternatively lifting the knees to an height given by the evaluator as fast as possible during 2 minutes. Measurements will take place one week before the first session (Week 1) and one week after the last session (Week 12). Number of repetitions (corresponding of each knee lift) will be measured. | Week 1 and Week 12 | 
| Change of one leg standing position time at Week 12 after intervention | This test is a part of the Senior Fitness Test assessment (Fournier et al., 2012). Participants will be asked to stay on one leg standing position and the maximal time they managed to maintain the position will be measured in seconds. Measurements will take place one week before the first session (Week 1) and one week after the last session (Week 12). | Week 1 and Week 12 | 
| Change of dual-task 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. Participants have to do the following cognitive task while walking : subtract 7 to a 3 digit number given by the evaluator and continuously subtract 7 to the result giving each operation results orally. Percentage of error in the cognitive task will be measured and spontaneous dual-task gait speed will be measured in meters per second. Measurements will take place one week before the first session (Week 1) and one week after the last session (Week 12). | Week 1 and Week 12 | 
| Change in fall rate at Week 36 after intervention | Fall rate will be measured using a 6 month follow up. Participants will be asked to fill in an online weekly report indicates whether they had falls or not during the past week. | From Week 12 to Week 36 | 
| Global cognition score at Week 1 | Participants will be asked to perform the different steps of the Montreal Cognitive Assessment following the instructions of the evaluator. This test evaluates multiple cognitive functions such as executive functions, memory, attention leading to a score between 0 (worse score) and 30 (best score). A score between 0 and 20 indicates a major cognitive impairment, a score between 20 and 25 indicates a mild cognitive impairment and and score superior to 25 indicates normal cognitive functioning. Measurement will take place one week before the first session (Week 1). | Week 1 | 
| Fall Risk score at Week 1 | Fall Risk will be measured using a 7 items questionnaire (Bongue et al., 2011) leading to a score between 0 (best score) and 12 (worst score). A score between 0 and 3 indicates a low risk of falling, a score between 4 and 7 indicates a moderate risk of falling and a score superior to 7 indicates a high risk of falling. Measurements will take place one week before the first session (Week 1). | Week 1 | 
| Common physical activity at Week 1 | Using a self-reported questionnaire named Physical Activity Questionnaire for the Elderly , participants will be asked to register all the physical activities they had on the past week and the time allowed to each activity (De Souto-Barretto et al., 2011). The amount of physical activity will be measured in Metabolic Equivalent Task per minutes per week. Measurements will take place one week before the first session (Week 1). | Week 1 | 
| Sedentary behaviors at Week 1 | Using a self-reported questionnaire named Recent Physical Activity Questionnaire (Golubic et al., 2014), participants will be asked to register all the sedentary behaviors they have usually each day and the time allowed to each behavior. The amount sedentary behavior will be measured in hour per day. Measurements will take place one week before the first session (Week 1). | Week 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dual-Task, Physical Activity, Prevention