Evaluation of a Personalized Physical Activity Coaching Program in Parkinson's Disease
- Conditions
- Parkinson's Disease
- Interventions
- Behavioral: Free practice of physical activityBehavioral: Personalized Physical Activity coaching program
- Registration Number
- NCT02816619
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- Clinical criteria for Parkinson's disease
- Men or women aged from 18 to 80 years old.
- Social security coverage.
- Ability to provide informed consent.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description APA- Free practice of physical activity APA- : patients will do free practice of physical activity during 3 months. APA+ Personalized Physical Activity coaching program APA + : patients will beneficiate of Personalized Physical Activity coaching program during 3 months (1 hour, twice by week, during 3 months)
- Primary Outcome Measures
Name Time Method Change from baseline of the Unified Parkinson Disease Rating Scale part III score at +3months
- Secondary Outcome Measures
Name Time Method Change from baseline of percentage of sedentarity, mild, moderate and intense activity using the eMOUVE application at + 6 months Change from baseline of VO2pic at + 6 months dropout rates at +6 months Change from baseline of muscular strength measured with isometric test at +6months Change from baseline of the 6 min Walking Test score at + 6 months 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 balancing abilities measured by stabilometry at + 6 months Change from baseline of fat and lean body mass measured by DEXA at +3 months. Change from baseline of Parkinson's Disease Questionnaire 39-item version score at +3months Change from baseline fat and lean body mass measured by DEXA at +6 months.
Trial Locations
- Locations (1)
CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, France