Evaluation of the Impact of a Personalized Program of Adapted Physical Activates in Patients With Parkinson Disease (ACTIPARK)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Personalized activity program
Sponsored by
About this trial
This is an interventional other trial for Parkinson Disease
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
Sites / Locations
- CHU Nimes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Adapted physical activity
Standard care
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Activity of patients in both groups
previous weeks' activity measured by actigraphy
Activity of patients in both groups
assessed by international physical activity questionnaire
Quality of life of patients undertaking APA verses standard care
Assessed by PDG-39 questionnaire
Quality of life of patients undertaking APA verses standard care
Assessed by PDG-39 questionnaire
Risk of fall of patients undertaking APA verses standard care
measured by Timed Up and Go test
Risk of fall of patients undertaking APA verses standard care
measured by Timed Up and Go test
Risk of fall of patients undertaking APA verses standard care
measured by Tinetti Falls Efficacy Scale
Risk of fall of patients undertaking APA verses standard care
measured by Tinetti Falls Efficacy Scale
Risk of fall of patients undertaking APA verses standard care
measured by 0-10 scale
Risk of fall of patients undertaking APA verses standard care
measured by 0-10 scale
Endurance and speed of walking of patients undertaking APA verses standard care
6 minute walk test
Endurance and speed of walking of patients undertaking APA verses standard care
6 minute walk test
Activity of the care giver
previous weeks' activity measured by actigraphy
Activity of the care giver
previous weeks' activity measured by actigraphy
Evaluation of the care burden of care giver
Zarit scale
Evaluation of the care burden of care giver
Zarit scale
Grip strength
Pinch test
Grip strength
Pinch test
Patient dependence
Activities of Daily Living
Patient dependence
Activities of Daily Living
Level of dementia at Day
Instrumental Activities of Daily Living
Level of dementia at Day
Instrumental Activities of Daily Living
Full Information
NCT ID
NCT03244813
First Posted
June 16, 2017
Last Updated
January 23, 2020
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT03244813
Brief Title
Evaluation of the Impact of a Personalized Program of Adapted Physical Activates in Patients With Parkinson Disease
Acronym
ACTIPARK
Official Title
Evaluation of the Impact of a Personalized Program of Adapted Physical Activates in Patients With Parkinson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
December 2, 2019 (Actual)
Study Completion Date
December 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The medical team assessing patient functional capacities and caregiver burden at 3 and 6 months will not know which treatment the patient received
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adapted physical activity
Arm Type
Experimental
Arm Title
Standard care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Personalized activity program
Intervention Description
Targeted physical activity
Primary Outcome Measure Information:
Title
Evaluate the impact of an adapted physical activity (APA) program versus standard care on the activity of patients with Parkinson Disease
Description
previous weeks' activity measured by actigraphy
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Activity of patients in both groups
Description
previous weeks' activity measured by actigraphy
Time Frame
6 months
Title
Activity of patients in both groups
Description
assessed by international physical activity questionnaire
Time Frame
6 months
Title
Quality of life of patients undertaking APA verses standard care
Description
Assessed by PDG-39 questionnaire
Time Frame
3 months
Title
Quality of life of patients undertaking APA verses standard care
Description
Assessed by PDG-39 questionnaire
Time Frame
6 months
Title
Risk of fall of patients undertaking APA verses standard care
Description
measured by Timed Up and Go test
Time Frame
3 months
Title
Risk of fall of patients undertaking APA verses standard care
Description
measured by Timed Up and Go test
Time Frame
6 months
Title
Risk of fall of patients undertaking APA verses standard care
Description
measured by Tinetti Falls Efficacy Scale
Time Frame
3 months
Title
Risk of fall of patients undertaking APA verses standard care
Description
measured by Tinetti Falls Efficacy Scale
Time Frame
6 months
Title
Risk of fall of patients undertaking APA verses standard care
Description
measured by 0-10 scale
Time Frame
3 months
Title
Risk of fall of patients undertaking APA verses standard care
Description
measured by 0-10 scale
Time Frame
6 months
Title
Endurance and speed of walking of patients undertaking APA verses standard care
Description
6 minute walk test
Time Frame
3 months
Title
Endurance and speed of walking of patients undertaking APA verses standard care
Description
6 minute walk test
Time Frame
6 months
Title
Activity of the care giver
Description
previous weeks' activity measured by actigraphy
Time Frame
3 months
Title
Activity of the care giver
Description
previous weeks' activity measured by actigraphy
Time Frame
6 months
Title
Evaluation of the care burden of care giver
Description
Zarit scale
Time Frame
3 months
Title
Evaluation of the care burden of care giver
Description
Zarit scale
Time Frame
6 months
Title
Grip strength
Description
Pinch test
Time Frame
Day 0
Title
Grip strength
Description
Pinch test
Time Frame
6 months
Title
Patient dependence
Description
Activities of Daily Living
Time Frame
Day 0
Title
Patient dependence
Description
Activities of Daily Living
Time Frame
6 months
Title
Level of dementia at Day
Description
Instrumental Activities of Daily Living
Time Frame
Day 0
Title
Level of dementia at Day
Description
Instrumental Activities of Daily Living
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHU Nimes
City
Nîmes
ZIP/Postal Code
30029
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Impact of a Personalized Program of Adapted Physical Activates in Patients With Parkinson Disease
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