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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Parkinson Disease

Treatments: Other: Personalized activity program

Study type: Interventional

Funder types: Other

Identifiers

NCT03244813

NIMAO/2016/EV-01

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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19 participants in 2 patient groups

Adapted physical activity

Experimental group

Treatment:

Other: Personalized activity program

Standard care

No Intervention group