Clinical trial NCT02816619: Evaluation of a Personalized Physical Activity Coaching Program in Parkinson's Disease
Official title: Evaluation of a Personalized Physical Activity Coaching Program in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Physical activity
Physical exercise
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
name: UFR STAPS
First posted: 2016-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of the Unified Parkinson Disease Rating Scale part III score
timeFrame: at +3months
Secondary outcomes:
measure: Change from baseline of Parkinson's Disease Questionnaire 39-item version score
timeFrame: at +3months
measure: Change from baseline of the Lawton and Brody Activities of Daily Living scale score
timeFrame: at +3months
measure: Change from baseline of the percentage of sedentarity, mild, moderate and intense activity using the eMOUVE application
timeFrame: at +3months
measure: Change from baseline of percentage of sedentarity, mild, moderate and intense activity using the eMOUVE application
timeFrame: at + 6 months
measure: Change from baseline of balancing abilities measured by stabilometry
timeFrame: at +3months
measure: Change from baseline of balancing abilities measured by stabilometry
timeFrame: at + 6 months
measure: Change from baseline of muscular strength measured with isometric test
timeFrame: at +3months
measure: Change from baseline of muscular strength measured with isometric test
timeFrame: at +6months
measure: Change from baseline of VO2pic
timeFrame: at +3months
measure: Change from baseline of VO2pic
timeFrame: at + 6 months
measure: Change from baseline of the 6 min Walking Test score
timeFrame: at +3 months
measure: Change from baseline of the 6 min Walking Test score
timeFrame: at + 6 months
measure: Change from baseline of fat and lean body mass measured by DEXA
timeFrame: at +3 months.
measure: Change from baseline fat and lean body mass measured by DEXA
timeFrame: at +6 months.
measure: dropout rates
timeFrame: at +3 months
measure: dropout rates
timeFrame: at +6 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
References: