Clinical trial NCT03244813: Evaluation of the Impact of a Personalized Program of Adapted Physical Activates in Patients With Parkinson Disease
Official title: Evaluation of the Impact of a Personalized Program of Adapted Physical Activates in Patients With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 19
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Our study aims to compare the effects of a standard care plan to one using adapted physical activity in patients with Parkinson Disease. Using actigraphy as an evaluation measure will allow the collection of quantitative and objective data related to activity in contrast to questionnaires which are more subjective and dependent on self-representation. In addition, the evaluation of the caregiver's actigraphy and hardship (Zarit scale) will provide interesting data from this population.


Eligibility criteria: Inclusion Criteria:

* The patient and their carer have given their free and informed consent and signed the consent form
* The patient must be insured of the beneficiary of an insurance policy
* The patient is available for the 6 month follow-up
* The patient is between 40 and 80 years old
* The patient has experienced symptoms of Parkinson Disease for at least 5 years and is in a stable state (no medical event or change of treatment in at least 1 month)
* The functional impact and duration of fluctuations is ≥3 (MDS UPDRS)
* The patient can walk autonomously, including using a technical aid
* The patient does not have any regular physical activity excluding physiotherapy sessions
* The patient has daily help from a caregiver

Exclusion Criteria:

* The subject and/or their caregiver is participating in another study
* The subject and/or their caregiver is in a period of exclusion determined by a previous study
* The patients is under judicial protection or state guardianship
* It proves impossible to give the patient and/or the caregiver clear information
* The patients and/or the caregiver reuses to sign the consent form
* The patient is pregnant or breast feeding
* The patient has anxiety or depression (Score HAD≥ 11/14), cardiac or respiratory failure (stress test), vesico-sphincter problems preventing normal practice of a physical activity, a contraindication to adapted physical activities
* The patient cannot walk
* Muscular tremor preventing the actigraphy measurement. Outside normal range values for UPDRS measures of: 3.15) postural tremor of the hands; 3.16) action tremor of the hands; 3.17) amplitude of rest tremor

Primary outcomes:
measure: Evaluate the impact of an adapted physical activity (APA) program versus standard care on the activity of patients with Parkinson Disease
timeFrame: 3 months
Secondary outcomes:
measure: Activity of patients in both groups
timeFrame: 6 months
measure: Activity of patients in both groups
timeFrame: 6 months
measure: Quality of life of patients undertaking APA verses standard care
timeFrame: 3 months
measure: Quality of life of patients undertaking APA verses standard care
timeFrame: 6 months
measure: Risk of fall of patients undertaking APA verses standard care
timeFrame: 3 months
measure: Risk of fall of patients undertaking APA verses standard care
timeFrame: 6 months
measure: Risk of fall of patients undertaking APA verses standard care
timeFrame: 3 months
measure: Risk of fall of patients undertaking APA verses standard care
timeFrame: 6 months
measure: Risk of fall of patients undertaking APA verses standard care
timeFrame: 3 months
measure: Risk of fall of patients undertaking APA verses standard care
timeFrame: 6 months
measure: Endurance and speed of walking of patients undertaking APA verses standard care
timeFrame: 3 months
measure: Endurance and speed of walking of patients undertaking APA verses standard care
timeFrame: 6 months
measure: Activity of the care giver
timeFrame: 3 months
measure: Activity of the care giver
timeFrame: 6 months
measure: Evaluation of the care burden of care giver
timeFrame: 3 months
measure: Evaluation of the care burden of care giver
timeFrame: 6 months
measure: Grip strength
timeFrame: Day 0
measure: Grip strength
timeFrame: 6 months
measure: Patient dependence
timeFrame: Day 0
measure: Patient dependence
timeFrame: 6 months
measure: Level of dementia at Day
timeFrame: Day 0
measure: Level of dementia at Day
timeFrame: 6 months
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
References: