Evaluation of the Impact of a Personalized Program of Adapted Physical Activates in Patients With Parkinson Disease

Centre Hospitalier Universitaire de Nīmes1 site in 1 country19 target enrollmentJanuary 10, 2018

ConditionsParkinson Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Parkinson Disease
Sponsor: Centre Hospitalier Universitaire de Nīmes
Enrollment: 19
Locations: 1
Primary Endpoint: Evaluate the impact of an adapted physical activity (APA) program versus standard care on the activity of patients with Parkinson Disease
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 10, 2018

End Date

December 2, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Nīmes

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Evaluate the impact of an adapted physical activity (APA) program versus standard care on the activity of patients with Parkinson Disease

Time Frame: 3 months

previous weeks' activity measured by actigraphy

Secondary Outcomes

Activity of the care giver(6 months)
Activity of patients in both groups(6 months)
Quality of life of patients undertaking APA verses standard care(6 months)
Endurance and speed of walking of patients undertaking APA verses standard care(6 months)
Risk of fall of patients undertaking APA verses standard care(6 months)
Patient dependence(6 months)
Evaluation of the care burden of care giver(6 months)
Grip strength(6 months)
Level of dementia at Day(6 months)