Evaluation of a Personalized Physical Activity Coaching Program in Parkinson's Disease

Parkinson's Disease Clinical Trial

— APA-PARK  

Official title:

Evaluation of a Personalized Physical Activity Coaching Program in Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02816619
• Other study ID #: CHU-0265
• Secondary ID: 2016-A00040-51
• Status: Recruiting
• Phase: N/A
• First received: June 3, 2016
• Last updated: June 27, 2016
• Start date: March 2016
• Est. completion date: September 2018

Study information

• Verified date: June 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Personalized Physical Activity coaching program

• Free practice of physical activity

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	AME2P, UFR STAPS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of the Unified Parkinson Disease Rating Scale part III score		at +3months	No
Secondary	Change from baseline of Parkinson's Disease Questionnaire 39-item version score		at +3months	No
Secondary	Change from baseline of the Lawton and Brody Activities of Daily Living scale score		at +3months	No
Secondary	Change from baseline of the percentage of sedentarity, mild, moderate and intense activity using the eMOUVE application		at +3months	No
Secondary	Change from baseline of percentage of sedentarity, mild, moderate and intense activity using the eMOUVE application		at + 6 months	No
Secondary	Change from baseline of balancing abilities measured by stabilometry		at +3months	No
Secondary	Change from baseline of balancing abilities measured by stabilometry		at + 6 months	No
Secondary	Change from baseline of muscular strength measured with isometric test		at +3months	No
Secondary	Change from baseline of muscular strength measured with isometric test		at +6months	No
Secondary	Change from baseline of VO2pic		at +3months	No
Secondary	Change from baseline of VO2pic		at + 6 months	No
Secondary	Change from baseline of the 6 min Walking Test score		at +3 months	No
Secondary	Change from baseline of the 6 min Walking Test score		at + 6 months	No
Secondary	Change from baseline of fat and lean body mass measured by DEXA		at +3 months.	No
Secondary	Change from baseline fat and lean body mass measured by DEXA		at +6 months.	No
Secondary	dropout rates		at +3 months	No
Secondary	dropout rates		at +6 months	No