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

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: Parkinson's Disease

Treatments: Behavioral: Free practice of physical activity; Behavioral: Personalized Physical Activity coaching program

Study type: Interventional

Funder types: Other

Identifiers

NCT02816619

2016-A00040-51 (Registry Identifier)

CHU-0265

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

APA+

Experimental group

Description:

APA + : patients will beneficiate of Personalized Physical Activity coaching program during 3 months (1 hour, twice by week, during 3 months)

Treatment:

Behavioral: Personalized Physical Activity coaching program

APA-

Other group

Description:

APA- : patients will do free practice of physical activity during 3 months.

Treatment:

Behavioral: Free practice of physical activity