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CompletedNCT02816619ClinicalTrials.gov record

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

Parkinson's Disease

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
18 years - 80 years
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
46 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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
Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Random assignment
Masking
Single masked
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

Personalized Physical Activity coaching program BEHAVIORAL

Not reported in this registry record.

Free practice of physical activity BEHAVIORAL

Not reported in this registry record.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Change from baseline of the Unified Parkinson Disease Rating Scale part III score

Time frame: at +3months

Not reported in this registry record.

Secondary measures

Change from baseline of Parkinson's Disease Questionnaire 39-item version score

Time frame: at +3months

Not reported in this registry record.

Change from baseline of the Lawton and Brody Activities of Daily Living scale score

Time frame: at +3months

Not reported in this registry record.

Change from baseline of the percentage of sedentarity, mild, moderate and intense activity using the eMOUVE application

Time frame: at +3months

Not reported in this registry record.

Change from baseline of percentage of sedentarity, mild, moderate and intense activity using the eMOUVE application

Time frame: at + 6 months

Not reported in this registry record.

Change from baseline of balancing abilities measured by stabilometry

Time frame: at +3months

Not reported in this registry record.

Change from baseline of balancing abilities measured by stabilometry

Time frame: at + 6 months

Not reported in this registry record.

Change from baseline of muscular strength measured with isometric test

Time frame: at +3months

Not reported in this registry record.

Change from baseline of muscular strength measured with isometric test

Time frame: at +6months

Not reported in this registry record.

Change from baseline of VO2pic

Time frame: at +3months

Not reported in this registry record.

Change from baseline of VO2pic

Time frame: at + 6 months

Not reported in this registry record.

Change from baseline of the 6 min Walking Test score

Time frame: at +3 months

Not reported in this registry record.

Change from baseline of the 6 min Walking Test score

Time frame: at + 6 months

Not reported in this registry record.

Change from baseline of fat and lean body mass measured by DEXA

Time frame: at +3 months.

Not reported in this registry record.

Change from baseline fat and lean body mass measured by DEXA

Time frame: at +6 months.

Not reported in this registry record.

dropout rates

Time frame: at +3 months

Not reported in this registry record.

dropout rates

Time frame: at +6 months

Not reported in this registry record.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

CHU Clermont-FerrandClermont-Ferrand, FranceStatus unknown

Study team and timeline

Lead sponsor
University Hospital, Clermont-Ferrand
Study start
Mar 24, 2016 Actual
Primary completion
Jun 30, 2018 Actual
Study completion
Sep 15, 2018 Actual
First posted
Jun 28, 2016 Estimated
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

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

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026