NCT04340492

Brief Summary

Parkinson's disease is a progressive disorders characterized by motor and non-motor symptoms. Actual medical treatments are symptomatic and have little efficacy on late stage axial motor symptoms. Non-pharmacological approaches are therefore essential from the disease onset. Beside physiotherapy, to practice a regular adapted physical activity is crucial. To implement such a practice in everyday life implies to change habits. Patient Education programs are useful tools to help changing behaviors. The study evaluate the effect of a program aiming to promote adapted physical activity in early stage Parkinson's disease by comparing patients receiving the program and patients on a waiting list. The hypothesis that the program will increase the one-week mean daily moderate to intense physical activity as measured with an actimeter.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2025

Completed
Last Updated

April 30, 2026

Status Verified

December 1, 2025

Enrollment Period

4.6 years

First QC Date

April 6, 2020

Last Update Submit

April 29, 2026

Conditions

Parkinson Disease

Keywords

Therapeutic Patient EducationAdapted physical activityActimetrySecondary preventionsensor monitoring

Outcome Measures

Primary Outcomes (1)

  • Change in time spent in moderate to vigorous physical activity during one week

    Daily physical activity is assessed with an actimeter (Actigraph GT9X).

    between baseline and 6 months after baseline

Secondary Outcomes (6)

  • Change in fatigue as assessed with the Parkinson Fatigue Scale (PFS)

    between baseline and 6 months after baseline

  • Change in quality of life as assessed with the PDQ-39 scale

    between baseline and 6 months after baseline

  • Change in Non-motor symptoms as assessed with the Non Motor Symptoms Scale (NMSS)

    between baseline and 6 months after baseline

  • Percentage of patients that complete all four sessions of the program

    At 3 months ( duration of the program)

  • Change in physical activity during one week, assessed with the International Physical Activity Questionnaire (IPAQ)

    between baseline and 6 months after baseline

  • +1 more secondary outcomes

Study Arms (2)

Adapted Physical Activity group

EXPERIMENTAL
Other: Education to Adapted Physical Activity

control group

SHAM COMPARATOR
Other: Standard care

Interventions

Education to Adapted Physical ActivityOTHER

4 group sessions (5 patients) aiming at promoting physical activity, the first three focusing respectively on endurance, posture and balance and power re-enforcement at one-week interval. A fourth session, 3 months latter is a consolidating session aiming at identify and overcome obstacles to practice physical activity in everyday life.

Adapted Physical Activity group
Standard careOTHER

Standard care concerning Parkinson's disease and physical activity

control group

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • suffering from Parkinson's disease according to Movement Disorders Society criteria,
  • with a diagnosis of Parkinson for 3 years or less,
  • with a stable treatment for Parkinson's disease for 3 months or more,
  • having signed the consent form

You may not qualify if:

  • Woman child-bearing or breath-feeding
  • Co-morbidities that influence or contraindicated adapted physical activity (severe respiratory symptoms, cardiopathy…)
  • Major depressive disorder according to DSM-V
  • Significant cognitive trouble (MOCA\<23)
  • Atypical parkinson's

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hop Salengro - Hopital B Chr Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Nicolas Carriere, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2020

First Posted

April 9, 2020

Study Start

March 15, 2021

Primary Completion

October 28, 2025

Study Completion

October 28, 2025

Last Updated

April 30, 2026

Record last verified: 2025-12

Locations

FR(1)