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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: Personalized activity program

• Registration Number: NCT03244813
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-08-07
• Study First Posted: 2017-08-10
• Study Start: 2018-01-10
• Primary Completion: 2019-12-02
• Study Completion: 2019-12-02
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-23
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adapted physical activity	Personalized activity program	-

Primary Outcome Measures

Name	Time	Method
Evaluate the impact of an adapted physical activity (APA) program versus standard care on the activity of patients with Parkinson Disease	3 months	previous weeks' activity measured by actigraphy

Secondary Outcome Measures

Name	Time	Method
Activity of the care giver	6 months	previous weeks' activity measured by actigraphy
Activity of patients in both groups	6 months	assessed by international physical activity questionnaire
Quality of life of patients undertaking APA verses standard care	6 months	Assessed by PDG-39 questionnaire
Endurance and speed of walking of patients undertaking APA verses standard care	6 months	6 minute walk test
Patient dependence	6 months	Activities of Daily Living
Risk of fall of patients undertaking APA verses standard care	6 months	measured by 0-10 scale
Evaluation of the care burden of care giver	6 months	Zarit scale
Grip strength	6 months	Pinch test
Level of dementia at Day	6 months	Instrumental Activities of Daily Living

Trial Locations

Locations (1)

CHU Nimes; 🇫🇷 Nîmes, France