Education for Adapted Physical Activity in Parkinson's Disease (ACTIF-PARK)
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Education to Adapted Physical Activity
Standard care
Sponsored by
About this trial
This is an interventional other trial for Parkinson Disease focused on measuring Therapeutic Patient Education, Adapted physical activity, Actimetry, Secondary prevention, sensor monitoring
Eligibility Criteria
Inclusion Criteria:
- suffering from Parkinson's disease according to Movement Disorders Society criteria,
- with a diagnosis of Parkinson for 3 years or less,
- with a stable treatment for Parkinson's disease for 3 months or more,
- having signed the consent form
Exclusion Criteria:
- Woman child-bearing or breath-feeding
- Co-morbidities that influence or contraindicated adapted physical activity (severe respiratory symptoms, cardiopathy…)
- Major depressive disorder according to DSM-V
- Significant cognitive trouble (MOCA<23)
- Atypical parkinson's
Sites / Locations
- Hop Salengro - Hopital B Chr LilleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Adapted Physical Activity group
control group
Arm Description
Outcomes
Primary Outcome Measures
Change in time spent in moderate to vigorous physical activity during one week
Daily physical activity is assessed with an actimeter (Actigraph GT9X).
Secondary Outcome Measures
Change in fatigue as assessed with the Parkinson Fatigue Scale (PFS)
This is a self-evaluation questionnaire, the physical aspects of fatigue and its influence on the everyday functionality and activity. An indication of the presence of clinically relevant fatigue is provided by the mean value calculated from the 16 items. A mean value of > 2.95 indicates the presence of fatigue symptoms
Change in quality of life as assessed with the PDQ-39 scale
Parkinson's Disease Quality of Life Questionnaire (PDQ-39): the 39-Item Parkinson's Disease Questionnaire (PDQ-39) is a commonly used measure of self-appraisal in PD. It is a measure of health status and quality of life, by assessing difficulties in 8 dimensions of daily living: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (4 items), communication (3 items) and bodily discomfort (3 items). The frequency of each event is determined by selecting one of 5 options: never (scored 0) / occasionally (scored 1) / sometimes (2) / often (3) / always (4). Each dimension total score range from 0 to 100, with lower scores reflecting better quality of life.
Change in Non-motor symptoms as assessed with the Non Motor Symptoms Scale (NMSS)
Non-motor symptoms scale for Parkinson's disease (NMSS). Non-motor symptoms are assessed over the last month. Each symptom is scored with respect to:
Severity: 0 = None; 1 = Mild: symptoms present but causes little distress or disturbance to patient; 2 = Moderate: some distress or disturbance to patient; 3 = Severe: major source of distress or disturbance to patient.
Frequency: 1 = Rarely (<1/wk); 2 = Often (1/wk); 3 = Frequent (several times per week); 4 = Very Frequent (daily or all the time).
NMSS contains nine dimensions: cardiovascular (2 items), sleep/fatigue (4 items), mood/cognition (6 items), perceptual problems (3 items), attention/memory (3 items), gastrointestinal (3 items), urinary (3 items), sexual function (2 items), and miscellaneous (4 items).
Subscores are calculated through multiplication of frequency x severity. Total score is calculated by adding all subscores, range 0-360.
Percentage of patients that complete all four sessions of the program
Change in physical activity during one week, assessed with the International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire (IPAQ) short form measures walking, moderate- and vigorous intensity, and total PA and daily time spent sitting on weekdays. PA was reported in MET·minutes/week and days per week and was scored using standardized IPAQ scoring protocols to yield total metabolic equivalent minutes (MET·minutes/week) of PA per week. Sitting time was reported as the amount of time in hours and/or minutes participants spent sitting on a weekday during the past seven days.
Change in Motor symptoms as assessed with the MDS-UPDRS-3
The Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. MDS-UPDRS Part III measures motor examination. Part III consists of 33 scores based on 18 items, and each question is anchored with five response scale from 0(normal) to 4(severe).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04340492
Brief Title
Education for Adapted Physical Activity in Parkinson's Disease
Acronym
ACTIF-PARK
Official Title
Effectiveness of Adapted Physical Activity Education on Physical Activity Daily in Patients With Parkinson's Disease at an Early Stage
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
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
Parkinson's disease is a progressive disorders characterized by motor and non-motor symptoms. Actual medical treatments are symptomatic and have little efficacy on late stage axial motor symptoms. Non-pharmacological approaches are therefore essential from the disease onset.
Beside physiotherapy, to practice a regular adapted physical activity is crucial. To implement such a practice in everyday life implies to change habits. Patient Education programs are useful tools to help changing behaviors.
The study evaluate the effect of a program aiming to promote adapted physical activity in early stage Parkinson's disease by comparing patients receiving the program and patients on a waiting list. The hypothesis that the program will increase the one-week mean daily moderate to intense physical activity as measured with an actimeter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Therapeutic Patient Education, Adapted physical activity, Actimetry, Secondary prevention, sensor monitoring
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adapted Physical Activity group
Arm Type
Experimental
Arm Title
control group
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Education to Adapted Physical Activity
Intervention Description
4 group sessions (5 patients) aiming at promoting physical activity, the first three focusing respectively on endurance, posture and balance and power re-enforcement at one-week interval. A fourth session, 3 months latter is a consolidating session aiming at identify and overcome obstacles to practice physical activity in everyday life.
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Standard care concerning Parkinson's disease and physical activity
Primary Outcome Measure Information:
Title
Change in time spent in moderate to vigorous physical activity during one week
Description
Daily physical activity is assessed with an actimeter (Actigraph GT9X).
Time Frame
between baseline and 6 months after baseline
Secondary Outcome Measure Information:
Title
Change in fatigue as assessed with the Parkinson Fatigue Scale (PFS)
Description
This is a self-evaluation questionnaire, the physical aspects of fatigue and its influence on the everyday functionality and activity. An indication of the presence of clinically relevant fatigue is provided by the mean value calculated from the 16 items. A mean value of > 2.95 indicates the presence of fatigue symptoms
Time Frame
between baseline and 6 months after baseline
Title
Change in quality of life as assessed with the PDQ-39 scale
Description
Parkinson's Disease Quality of Life Questionnaire (PDQ-39): the 39-Item Parkinson's Disease Questionnaire (PDQ-39) is a commonly used measure of self-appraisal in PD. It is a measure of health status and quality of life, by assessing difficulties in 8 dimensions of daily living: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (4 items), communication (3 items) and bodily discomfort (3 items). The frequency of each event is determined by selecting one of 5 options: never (scored 0) / occasionally (scored 1) / sometimes (2) / often (3) / always (4). Each dimension total score range from 0 to 100, with lower scores reflecting better quality of life.
Time Frame
between baseline and 6 months after baseline
Title
Change in Non-motor symptoms as assessed with the Non Motor Symptoms Scale (NMSS)
Description
Non-motor symptoms scale for Parkinson's disease (NMSS). Non-motor symptoms are assessed over the last month. Each symptom is scored with respect to:
Severity: 0 = None; 1 = Mild: symptoms present but causes little distress or disturbance to patient; 2 = Moderate: some distress or disturbance to patient; 3 = Severe: major source of distress or disturbance to patient.
Frequency: 1 = Rarely (<1/wk); 2 = Often (1/wk); 3 = Frequent (several times per week); 4 = Very Frequent (daily or all the time).
NMSS contains nine dimensions: cardiovascular (2 items), sleep/fatigue (4 items), mood/cognition (6 items), perceptual problems (3 items), attention/memory (3 items), gastrointestinal (3 items), urinary (3 items), sexual function (2 items), and miscellaneous (4 items).
Subscores are calculated through multiplication of frequency x severity. Total score is calculated by adding all subscores, range 0-360.
Time Frame
between baseline and 6 months after baseline
Title
Percentage of patients that complete all four sessions of the program
Time Frame
At 3 months ( duration of the program)
Title
Change in physical activity during one week, assessed with the International Physical Activity Questionnaire (IPAQ)
Description
The International Physical Activity Questionnaire (IPAQ) short form measures walking, moderate- and vigorous intensity, and total PA and daily time spent sitting on weekdays. PA was reported in MET·minutes/week and days per week and was scored using standardized IPAQ scoring protocols to yield total metabolic equivalent minutes (MET·minutes/week) of PA per week. Sitting time was reported as the amount of time in hours and/or minutes participants spent sitting on a weekday during the past seven days.
Time Frame
between baseline and 6 months after baseline
Title
Change in Motor symptoms as assessed with the MDS-UPDRS-3
Description
The Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. MDS-UPDRS Part III measures motor examination. Part III consists of 33 scores based on 18 items, and each question is anchored with five response scale from 0(normal) to 4(severe).
Time Frame
between baseline and 6 months after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
suffering from Parkinson's disease according to Movement Disorders Society criteria,
with a diagnosis of Parkinson for 3 years or less,
with a stable treatment for Parkinson's disease for 3 months or more,
having signed the consent form
Exclusion Criteria:
Woman child-bearing or breath-feeding
Co-morbidities that influence or contraindicated adapted physical activity (severe respiratory symptoms, cardiopathy…)
Major depressive disorder according to DSM-V
Significant cognitive trouble (MOCA<23)
Atypical parkinson's
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Carriere, MD
Phone
3 20 44 67 52
Ext
+33
Email
nicolas.carriere@chru-lille.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Philippe Caron
Phone
3 20 44 67 52
Ext
+33
Email
kine.parkinson@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Carriere, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hop Salengro - Hopital B Chr Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0320445962
12. IPD Sharing Statement
Learn more about this trial
Education for Adapted Physical Activity in Parkinson's Disease
We'll reach out to this number within 24 hrs