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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Personalized activity program

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • Chu Nimes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care
Experimental: Adapted physical activity	Other: Personalized activity program; Targeted physical activity

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity of patients in both groups	previous weeks' activity measured by actigraphy	6 months
Activity of patients in both groups	assessed by international physical activity questionnaire	6 months
Quality of life of patients undertaking APA verses standard care	Assessed by PDG-39 questionnaire	3 months
Quality of life of patients undertaking APA verses standard care	Assessed by PDG-39 questionnaire	6 months
Risk of fall of patients undertaking APA verses standard care	measured by Timed Up and Go test	3 months
Risk of fall of patients undertaking APA verses standard care	measured by Timed Up and Go test	6 months
Risk of fall of patients undertaking APA verses standard care	measured by Tinetti Falls Efficacy Scale	3 months
Risk of fall of patients undertaking APA verses standard care	measured by Tinetti Falls Efficacy Scale	6 months
Risk of fall of patients undertaking APA verses standard care	measured by 0-10 scale	3 months
Risk of fall of patients undertaking APA verses standard care	measured by 0-10 scale	6 months
Endurance and speed of walking of patients undertaking APA verses standard care	6 minute walk test	3 months
Endurance and speed of walking of patients undertaking APA verses standard care	6 minute walk test	6 months
Activity of the care giver	previous weeks' activity measured by actigraphy	3 months
Activity of the care giver	previous weeks' activity measured by actigraphy	6 months
Evaluation of the care burden of care giver	Zarit scale	3 months
Evaluation of the care burden of care giver	Zarit scale	6 months
Grip strength	Pinch test	Day 0
Grip strength	Pinch test	6 months
Patient dependence	Activities of Daily Living	Day 0
Patient dependence	Activities of Daily Living	6 months
Level of dementia at Day	Instrumental Activities of Daily Living	Day 0
Level of dementia at Day	Instrumental Activities of Daily Living	6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2018
• Primary Completion (Actual): December 2, 2019
• Study Completion (Actual): December 2, 2019

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 10, 2017

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 23, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: NIMAO/2016/EV-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No