NCT02816619

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

June 28, 2016

Status Verified

June 1, 2016

Enrollment Period

2.3 years

First QC Date

June 3, 2016

Last Update Submit

June 27, 2016

Conditions

Parkinson's Disease

Keywords

Parkinson's diseasePhysical activityPhysical exercise

Outcome Measures

Primary Outcomes (1)

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

    at +3months

Secondary Outcomes (16)

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

    at +3months

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

    at +3months

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

    at +3months

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

    at + 6 months

  • Change from baseline of balancing abilities measured by stabilometry

    at +3months

  • +11 more secondary outcomes

Study Arms (2)

APA+

EXPERIMENTAL

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-

OTHER

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

Behavioral: Free practice of physical activity

Interventions

Personalized Physical Activity coaching programBEHAVIORAL
APA+
Free practice of physical activityBEHAVIORAL
APA-

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical criteria for Parkinson's disease
  • Men or women aged from 18 to 80 years old.
  • Social security coverage.
  • Ability to provide informed consent.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (3)

  • Zanchet C, Lambert C, Boyer T, Pereira B, Derost P, Debilly B, Duclos M, Boisseau N, Marques A. Effect of an adapted physical activity program in Parkinson's disease: A randomized controlled study (APA-Park). Parkinsonism Relat Disord. 2025 May;134:107777. doi: 10.1016/j.parkreldis.2025.107777. Epub 2025 Mar 10.

    PMID: 40088781DERIVED

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

    PMID: 38588457DERIVED

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

    PMID: 36602886DERIVED

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavior

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2016

First Posted

June 28, 2016

Study Start

March 1, 2016

Primary Completion

June 1, 2018

Study Completion

September 1, 2018

Last Updated

June 28, 2016

Record last verified: 2016-06

Locations

FR(1)