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

Parkinson Disease Clinical Trial

— ACTIPARK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03244813
• Other study ID #: NIMAO/2016/EV-01
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: December 2, 2019

Study information

• Verified date: January 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2, 2019
• Est. primary completion date: December 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Personalized activity program
Targeted physical activity

Locations

Country	Name	City	State
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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