Evaluation of a Personalized Physical Activity Coaching Program in Parkinson's Disease

Study Overview
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Brief Summary
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There is growing interest for physical activity in Parkinson's disease in order to improve mobility and function of these patients. It seems from previous studies that difficulty, intensity and specificity of physical exercises are important parameters conditioning the effect of physical activity on cerebral plasticity and clinical improvement. Thus, the aim of this study is to evaluate the benefits of a Personalized Physical Activity coaching program, including scheduled and frequent follow up associated with progressive readaptation of exercise intensity depending on individual performances (during 3 months), versus free practice of physical activity in Parkinson's disease.

Detailed Description
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Type of study: a randomized, single-blind, parallel-group, controlled clinical trial. Number of centers: 1 (Clermont-Ferrand) Patients Patients eligible for inclusion will be randomized to one of the two groups: APA + : patients will beneficiate of Personalized Physical Activity coaching program during 3 months (1 hour, twice by week, during 3 months) APA- : patients will do free practice of physical activity during 3 months. Study Performance Patients will be evaluated 3 times : at J0 (baseline, V1), 3 months after Personalized Physical Activity coaching program (J0+3M, V2), and 3 months after the end of the Personalized Physical Activity coaching program (J0+6M) V1: Signature of an informed consent form. Demographic and clinical characteristics (sex, age, disease duration, treatments). V1, V2, V3 Neurological evaluation (Unified Parkinson Disease Rating Scale part III score) Evaluation of quality of life (Parkinson's Disease Questionnaire 39-item version (PDQ-39), participation to Daily life activities (Lawton and Brody Activities of Daily Living scale (IADL questionnaire25) Evaluation of performances for specific tests for balance (stabilometry), muscular strength (isometry) Evaluation of cardiorespiratory function (VO2pic et 6 min Walk Test) Evaluation of body composition (lean body mass/fat mass) with DEXA. Dropout rates at V2 and V3 Evaluation of the activity with the eMOUVE application in a subgroup of patients.

Official Title
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Evaluation of a Personalized Physical Activity Coaching Program in Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Behavioral: Personalized Physical Activity coaching program
* Behavioral: Free practice of physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical criteria for Parkinson's disease Men or women aged from 18 to 80 years old. Social security coverage. Ability to provide informed consent. Exclusion Criteria: neurological disease other than Parkinson's disease severe depression (Beck Depression Inventory>37) or psychiatric comorbidities (UPDRS I ) significant cognitive impairment (MoCA<24) orthopedic impairment with functional restriction contraindication to physical exercise

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APA+<br>APA + : patients will beneficiate of Personalized Physical Activity coaching program during 3 months (1 hour, twice by week, during 3 months) | Behavioral: Personalized Physical Activity coaching program<br> <br> |
| Other: APA-<br>APA- : patients will do free practice of physical activity during 3 months. | Behavioral: Free practice of physical activity<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of the Unified Parkinson Disease Rating Scale part III score |  | at +3months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Parkinson's Disease Questionnaire 39-item version score |  | at +3months | 
| Change from baseline of the Lawton and Brody Activities of Daily Living scale score |  | at +3months | 
| Change from baseline of the percentage of sedentarity, mild, moderate and intense activity using the eMOUVE application |  | at +3months | 
| Change from baseline of percentage of sedentarity, mild, moderate and intense activity using the eMOUVE application |  | at + 6 months | 
| Change from baseline of balancing abilities measured by stabilometry |  | at +3months | 
| Change from baseline of balancing abilities measured by stabilometry |  | at + 6 months | 
| Change from baseline of muscular strength measured with isometric test |  | at +3months | 
| Change from baseline of muscular strength measured with isometric test |  | at +6months | 
| Change from baseline of VO2pic |  | at +3months | 
| Change from baseline of VO2pic |  | at + 6 months | 
| Change from baseline of the 6 min Walking Test score |  | at +3 months | 
| Change from baseline of the 6 min Walking Test score |  | at + 6 months | 
| Change from baseline of fat and lean body mass measured by DEXA |  | at +3 months. | 
| Change from baseline fat and lean body mass measured by DEXA |  | at +6 months. | 
| dropout rates |  | at +3 months | 
| dropout rates |  | at +6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Physical activity, Physical exercise