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Evaluation of a Personalized Physical Activity Coaching Program in Parkinson's Disease (APA-PARK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02816619
Recruitment Status : Unknown
Verified June 2016 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : June 28, 2016
Last Update Posted : June 28, 2016
Sponsor:
Collaborators:
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
UFR STAPS
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
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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.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Behavioral: Personalized Physical Activity coaching program Behavioral: Free practice of physical activity Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of a Personalized Physical Activity Coaching Program in Parkinson's Disease
Study Start Date : March 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: APA+
APA + : patients will beneficiate of Personalized Physical Activity coaching program during 3 months (1 hour, twice by week, during 3 months)
 Behavioral: Personalized Physical Activity coaching program
APA-
APA- : patients will do free practice of physical activity during 3 months.
 Behavioral: Free practice of physical activity


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline of the Unified Parkinson Disease Rating Scale part III score [ Time Frame: at +3months ]

Secondary Outcome Measures :
  1. Change from baseline of Parkinson's Disease Questionnaire 39-item version score [ Time Frame: at +3months ]
  2. Change from baseline of the Lawton and Brody Activities of Daily Living scale score [ Time Frame: at +3months ]
  3. Change from baseline of the percentage of sedentarity, mild, moderate and intense activity using the eMOUVE application [ Time Frame: at +3months ]
  4. Change from baseline of percentage of sedentarity, mild, moderate and intense activity using the eMOUVE application [ Time Frame: at + 6 months ]
  5. Change from baseline of balancing abilities measured by stabilometry [ Time Frame: at +3months ]
  6. Change from baseline of balancing abilities measured by stabilometry [ Time Frame: at + 6 months ]
  7. Change from baseline of muscular strength measured with isometric test [ Time Frame: at +3months ]
  8. Change from baseline of muscular strength measured with isometric test [ Time Frame: at +6months ]
  9. Change from baseline of VO2pic [ Time Frame: at +3months ]
  10. Change from baseline of VO2pic [ Time Frame: at + 6 months ]
  11. Change from baseline of the 6 min Walking Test score [ Time Frame: at +3 months ]
  12. Change from baseline of the 6 min Walking Test score [ Time Frame: at + 6 months ]
  13. Change from baseline of fat and lean body mass measured by DEXA [ Time Frame: at +3 months. ]
  14. Change from baseline fat and lean body mass measured by DEXA [ Time Frame: at +6 months. ]
  15. dropout rates [ Time Frame: at +3 months ]
  16. dropout rates [ Time Frame: at +6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02816619


Contacts
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Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
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France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Anna Marques         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
UFR STAPS
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02816619    
Other Study ID Numbers: CHU-0265
2016-A00040-51 ( Registry Identifier: 2016-A00040-51 )
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016
Keywords provided by University Hospital, Clermont-Ferrand:
Parkinson's disease
Physical activity
Physical exercise
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases