Parkinson's Disease Clinical Trial
Official title:
Evaluation of a Personalized Physical Activity Coaching Program in Parkinson's Disease
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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