Parkinson's Disease
Conditions
Keywords
Parkinson's disease, Physical activity, Physical exercise
Brief summary
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
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.
Interventions
BEHAVIORALPersonalized Physical Activity coaching program
BEHAVIORALFree practice of physical activity
Sponsors
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
UFR STAPS
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline of the Unified Parkinson Disease Rating Scale part III score | at +3months |
Secondary
| Measure | Time frame |
|---|---|
| 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 muscular strength measured with isometric test | at +3months |
| Change from baseline of Parkinson's Disease Questionnaire 39-item version score | at +3months |
| Change from baseline of the 6 min Walking Test score | at +3 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 |
| Change from baseline of VO2pic | at +3months |
Countries
France
Contacts
Primary ContactPatrick LACARIN
Outcome results
None listed