Evaluation of a Personalized Physical Activity Coaching Program in Parkinson's Disease (APA-PARK)
Primary Purpose
Parkinson's Disease
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Personalized Physical Activity coaching program
Free practice of physical activity
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Physical activity, Physical exercise
Eligibility Criteria
Inclusion Criteria:
- Clinical criteria for Parkinson's disease
- Men or women aged from 18 to 80 years old.
- Social security coverage.
- Ability to provide informed consent.
Exclusion Criteria:
- neurological disease other than Parkinson's disease
- severe depression (Beck Depression Inventory>37) or psychiatric comorbidities (UPDRS I )
- significant cognitive impairment (MoCA<24)
- orthopedic impairment with functional restriction
- contraindication to physical exercise
Sites / Locations
- CHU Clermont-FerrandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
APA+
APA-
Arm Description
APA + : patients will beneficiate of Personalized Physical Activity coaching program during 3 months (1 hour, twice by week, during 3 months)
APA- : patients will do free practice of physical activity during 3 months.
Outcomes
Primary Outcome Measures
Change from baseline of the Unified Parkinson Disease Rating Scale part III score
Secondary Outcome Measures
Change from baseline of Parkinson's Disease Questionnaire 39-item version score
Change from baseline of the Lawton and Brody Activities of Daily Living scale score
Change from baseline of the percentage of sedentarity, mild, moderate and intense activity using the eMOUVE application
Change from baseline of percentage of sedentarity, mild, moderate and intense activity using the eMOUVE application
Change from baseline of balancing abilities measured by stabilometry
Change from baseline of balancing abilities measured by stabilometry
Change from baseline of muscular strength measured with isometric test
Change from baseline of muscular strength measured with isometric test
Change from baseline of VO2pic
Change from baseline of VO2pic
Change from baseline of the 6 min Walking Test score
Change from baseline of the 6 min Walking Test score
Change from baseline of fat and lean body mass measured by DEXA
Change from baseline fat and lean body mass measured by DEXA
dropout rates
dropout rates
Full Information
NCT ID
NCT02816619
First Posted
June 3, 2016
Last Updated
June 27, 2016
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques, UFR STAPS
1. Study Identification
Unique Protocol Identification Number
NCT02816619
Brief Title
Evaluation of a Personalized Physical Activity Coaching Program in Parkinson's Disease
Acronym
APA-PARK
Official Title
Evaluation of a Personalized Physical Activity Coaching Program in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques, UFR STAPS
4. Oversight
5. Study Description
Brief Summary
There is growing interest for physical activity in Parkinson's disease in order to improve mobility and function of these patients. It seems from previous studies that difficulty, intensity and specificity of physical exercises are important parameters conditioning the effect of physical activity on cerebral plasticity and clinical improvement.
Thus, the aim of this study is to evaluate the benefits of a Personalized Physical Activity coaching program, including scheduled and frequent follow up associated with progressive readaptation of exercise intensity depending on individual performances (during 3 months), versus free practice of physical activity in Parkinson's disease.
Detailed Description
Type of study: a randomized, single-blind, parallel-group, controlled clinical trial.
Number of centers: 1 (Clermont-Ferrand)
Patients
Patients eligible for inclusion will be randomized to one of the two groups:
APA + : patients will beneficiate of Personalized Physical Activity coaching program during 3 months (1 hour, twice by week, during 3 months)
APA- : patients will do free practice of physical activity during 3 months.
Study Performance Patients will be evaluated 3 times : at J0 (baseline, V1), 3 months after Personalized Physical Activity coaching program (J0+3M, V2), and 3 months after the end of the Personalized Physical Activity coaching program (J0+6M)
V1:
Signature of an informed consent form.
Demographic and clinical characteristics (sex, age, disease duration, treatments).
V1, V2, V3
Neurological evaluation (Unified Parkinson Disease Rating Scale part III score)
Evaluation of quality of life (Parkinson's Disease Questionnaire 39-item version (PDQ-39), participation to Daily life activities (Lawton and Brody Activities of Daily Living scale (IADL questionnaire25)
Evaluation of performances for specific tests for balance (stabilometry), muscular strength (isometry)
Evaluation of cardiorespiratory function (VO2pic et 6 min Walk Test)
Evaluation of body composition (lean body mass/fat mass) with DEXA.
Dropout rates at V2 and V3
Evaluation of the activity with the eMOUVE application in a subgroup of patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Physical activity, Physical exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
APA+
Arm Type
Experimental
Arm Description
APA + : patients will beneficiate of Personalized Physical Activity coaching program during 3 months (1 hour, twice by week, during 3 months)
Arm Title
APA-
Arm Type
Other
Arm Description
APA- : patients will do free practice of physical activity during 3 months.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Physical Activity coaching program
Intervention Type
Behavioral
Intervention Name(s)
Free practice of physical activity
Primary Outcome Measure Information:
Title
Change from baseline of the Unified Parkinson Disease Rating Scale part III score
Time Frame
at +3months
Secondary Outcome Measure Information:
Title
Change from baseline of Parkinson's Disease Questionnaire 39-item version score
Time Frame
at +3months
Title
Change from baseline of the Lawton and Brody Activities of Daily Living scale score
Time Frame
at +3months
Title
Change from baseline of the percentage of sedentarity, mild, moderate and intense activity using the eMOUVE application
Time Frame
at +3months
Title
Change from baseline of percentage of sedentarity, mild, moderate and intense activity using the eMOUVE application
Time Frame
at + 6 months
Title
Change from baseline of balancing abilities measured by stabilometry
Time Frame
at +3months
Title
Change from baseline of balancing abilities measured by stabilometry
Time Frame
at + 6 months
Title
Change from baseline of muscular strength measured with isometric test
Time Frame
at +3months
Title
Change from baseline of muscular strength measured with isometric test
Time Frame
at +6months
Title
Change from baseline of VO2pic
Time Frame
at +3months
Title
Change from baseline of VO2pic
Time Frame
at + 6 months
Title
Change from baseline of the 6 min Walking Test score
Time Frame
at +3 months
Title
Change from baseline of the 6 min Walking Test score
Time Frame
at + 6 months
Title
Change from baseline of fat and lean body mass measured by DEXA
Time Frame
at +3 months.
Title
Change from baseline fat and lean body mass measured by DEXA
Time Frame
at +6 months.
Title
dropout rates
Time Frame
at +3 months
Title
dropout rates
Time Frame
at +6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical criteria for Parkinson's disease
Men or women aged from 18 to 80 years old.
Social security coverage.
Ability to provide informed consent.
Exclusion Criteria:
neurological disease other than Parkinson's disease
severe depression (Beck Depression Inventory>37) or psychiatric comorbidities (UPDRS I )
significant cognitive impairment (MoCA<24)
orthopedic impairment with functional restriction
contraindication to physical exercise
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Anna Marques
12. IPD Sharing Statement
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Evaluation of a Personalized Physical Activity Coaching Program in Parkinson's Disease
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