Education for Adapted Physical Activity in Parkinson's Disease

Parkinson Disease Clinical Trial

— ACTIF-PARK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04340492
• Other study ID #: 2018_91
• Secondary ID: 2019-A02488-49
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: May 2024

Study information

• Verified date: May 2022
• Source: University Hospital, Lille
• Contact: Nicolas Carriere, MD
• Phone: 3 20 44 67 52
• Email: nicolas.carriere[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Education to Adapted Physical Activity
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.
• Standard care
Standard care concerning Parkinson's disease and physical activity

Locations

Country	Name	City	State
France	Hop Salengro - Hopital B Chr Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in fatigue as assessed with the Parkinson Fatigue Scale (PFS)	This is a self-evaluation questionnaire, the physical aspects of fatigue and its influence on the everyday functionality and activity. An indication of the presence of clinically relevant fatigue is provided by the mean value calculated from the 16 items. A mean value of > 2.95 indicates the presence of fatigue symptoms	between baseline and 6 months after baseline
Secondary	Change in quality of life as assessed with the PDQ-39 scale	Parkinson's Disease Quality of Life Questionnaire (PDQ-39): the 39-Item Parkinson's Disease Questionnaire (PDQ-39) is a commonly used measure of self-appraisal in PD. It is a measure of health status and quality of life, by assessing difficulties in 8 dimensions of daily living: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (4 items), communication (3 items) and bodily discomfort (3 items). The frequency of each event is determined by selecting one of 5 options: never (scored 0) / occasionally (scored 1) / sometimes (2) / often (3) / always (4). Each dimension total score range from 0 to 100, with lower scores reflecting better quality of life.	between baseline and 6 months after baseline
Secondary	Change in Non-motor symptoms as assessed with the Non Motor Symptoms Scale (NMSS)	Non-motor symptoms scale for Parkinson's disease (NMSS). Non-motor symptoms are assessed over the last month. Each symptom is scored with respect to: Severity: 0 = None; 1 = Mild: symptoms present but causes little distress or disturbance to patient; 2 = Moderate: some distress or disturbance to patient; 3 = Severe: major source of distress or disturbance to patient.; Frequency: 1 = Rarely (<1/wk); 2 = Often (1/wk); 3 = Frequent (several times per week); 4 = Very Frequent (daily or all the time).; NMSS contains nine dimensions: cardiovascular (2 items), sleep/fatigue (4 items), mood/cognition (6 items), perceptual problems (3 items), attention/memory (3 items), gastrointestinal (3 items), urinary (3 items), sexual function (2 items), and miscellaneous (4 items).; Subscores are calculated through multiplication of frequency x severity. Total score is calculated by adding all subscores, range 0-360.	between baseline and 6 months after baseline
Secondary	Percentage of patients that complete all four sessions of the program		At 3 months ( duration of the program)
Secondary	Change in physical activity during one week, assessed with the International Physical Activity Questionnaire (IPAQ)	The International Physical Activity Questionnaire (IPAQ) short form measures walking, moderate- and vigorous intensity, and total PA and daily time spent sitting on weekdays. PA was reported in MET·minutes/week and days per week and was scored using standardized IPAQ scoring protocols to yield total metabolic equivalent minutes (MET·minutes/week) of PA per week. Sitting time was reported as the amount of time in hours and/or minutes participants spent sitting on a weekday during the past seven days.	between baseline and 6 months after baseline
Secondary	Change in Motor symptoms as assessed with the MDS-UPDRS-3	The Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. MDS-UPDRS Part III measures motor examination. Part III consists of 33 scores based on 18 items, and each question is anchored with five response scale from 0(normal) to 4(severe).	between baseline and 6 months after baseline