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Clinical Trials/NCT04340492
NCT04340492CompletedNot Applicable

Effectiveness of Adapted Physical Activity Education on Physical Activity Daily in Patients With Parkinson's Disease at an Early Stage

University Hospital, Lille2 sites in 1 country89 target enrollmentStarted: March 15, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
89
Locations
2
Primary Endpoint
Change in time spent in moderate to vigorous physical activity during one week

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
30 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

Adapted Physical Activity group

Experimental

Intervention: Education to Adapted Physical Activity (Other)

control group

Sham Comparator

Intervention: Standard care (Other)

Outcomes

Primary Outcomes

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

Time Frame: between baseline and 6 months after baseline

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

Secondary Outcomes

  • Change in physical activity during one week, assessed with the International Physical Activity Questionnaire (IPAQ)(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 quality of life as assessed with the PDQ-39 scale(between baseline and 6 months after baseline)
  • Change in Motor symptoms as assessed with the MDS-UPDRS-3(between baseline and 6 months after baseline)
  • Change in fatigue as assessed with the Parkinson Fatigue Scale (PFS)(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)

Investigators

Sponsor
University Hospital, Lille
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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