Clinical trial NCT04340492: Education for Adapted Physical Activity in Parkinson's Disease
Official title: Effectiveness of Adapted Physical Activity Education on Physical Activity Daily in Patients With Parkinson's Disease at an Early Stage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Therapeutic Patient Education
Adapted physical activity
Actimetry
Secondary prevention
sensor monitoring
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Parkinson's disease is a progressive disorders characterized by motor and non-motor symptoms. Actual medical treatments are symptomatic and have little efficacy on late stage axial motor symptoms. Non-pharmacological approaches are therefore essential from the disease onset.

Beside physiotherapy, to practice a regular adapted physical activity is crucial. To implement such a practice in everyday life implies to change habits. Patient Education programs are useful tools to help changing behaviors.

The study evaluate the effect of a program aiming to promote adapted physical activity in early stage Parkinson's disease by comparing patients receiving the program and patients on a waiting list. The hypothesis that the program will increase the one-week mean daily moderate to intense physical activity as measured with an actimeter.


Eligibility criteria: Inclusion Criteria:

* suffering from Parkinson's disease according to Movement Disorders Society criteria,
* with a diagnosis of Parkinson for 3 years or less,
* with a stable treatment for Parkinson's disease for 3 months or more,
* having signed the consent form

Exclusion Criteria:

* Woman child-bearing or breath-feeding
* Co-morbidities that influence or contraindicated adapted physical activity (severe respiratory symptoms, cardiopathy...)
* Major depressive disorder according to DSM-V
* Significant cognitive trouble (MOCA\<23)
* Atypical parkinson's

Primary outcomes:
measure: Change in time spent in moderate to vigorous physical activity during one week
timeFrame: between baseline and 6 months after baseline
Secondary outcomes:
measure: Change in fatigue as assessed with the Parkinson Fatigue Scale (PFS)
timeFrame: between baseline and 6 months after baseline
measure: Change in quality of life as assessed with the PDQ-39 scale
timeFrame: between baseline and 6 months after baseline
measure: Change in Non-motor symptoms as assessed with the Non Motor Symptoms Scale (NMSS)
timeFrame: between baseline and 6 months after baseline
measure: Percentage of patients that complete all four sessions of the program
timeFrame: At 3 months ( duration of the program)
measure: Change in physical activity during one week, assessed with the International Physical Activity Questionnaire (IPAQ)
timeFrame: between baseline and 6 months after baseline
measure: Change in Motor symptoms as assessed with the MDS-UPDRS-3
timeFrame: between baseline and 6 months after baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Salengro - Hopital B Chr Lille
Study officials:
affiliation: University Hospital, Lille
name: Nicolas Carriere, MD
role: PRINCIPAL_INVESTIGATOR
References: