Parkinson DiseaseACTIF-PARKNCT04340492
Education for Adapted Physical Activity in Parkinson's Disease
A study testing Education to Adapted Physical Activity in people with Parkinson Disease, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Education to Adapted Physical Activity
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2021to 28 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Adapted Physical Activity Education on Physical Activity Daily in Patients With Parkinson's Disease at an Early Stage
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.
- Conditions
- Parkinson Disease
- Being tested
- Education to Adapted Physical Activity, Standard care
- Keywords
- Therapeutic Patient Education, Adapted physical activity, Actimetry, Secondary prevention, sensor monitoring
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Standard careOther
Standard care concerning Parkinson's disease and physical activity
| Study group | Role | What they receive |
|---|---|---|
| Adapted Physical Activity group | Experimental | Not described Receives: Other: Education to Adapted Physical Activity |
| control group | Sham comparator | Not described Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in time spent in moderate to vigorous physical activity during one week
Daily physical activity is assessed with an actimeter (Actigraph GT9X).
Measured: between baseline and 6 months after baseline
Secondary outcomes (6)
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
Measured: between baseline and 6 months after baseline
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.
Measured: between baseline and 6 months after baseline
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.
Measured: between baseline and 6 months after baseline
Percentage of patients that complete all four sessions of the program
Measured: At 3 months ( duration of the program)
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.
Measured: between baseline and 6 months after baseline
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).
Measured: between baseline and 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start15 Mar 2021
- Primary completion28 Oct 2025
- Study completion28 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Carriere, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340492
- Sponsor's protocol ID
- 2018_71
- Other IDs
- 2019-A02488-49
- Acronym
- ACTIF-PARK
- Status last verified
- Dec 2025
- First submitted
- 6 Apr 2020
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Adapted Physical Activity Education on Physical Activity Daily in Patients With Parkinson's Disease at an Early Stage
- ClinicalTrials.gov ID
- NCT04340492
- Acronym / sponsor ID
- ACTIF-PARK / 2018_71
- Conditions
- Parkinson Disease
- Keywords
- Therapeutic Patient Education, Adapted physical activity, Actimetry, Secondary prevention, sensor monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- 28 Oct 2025 (actual)
- First posted
- 9 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted Physical Activity group | Experimental | Other: Education to Adapted Physical Activity |
| control group | Sham comparator | Other: Standard care |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education to Adapted Physical Activity4 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. | Other | Adapted Physical Activity group |
| Standard careStandard care concerning Parkinson's disease and physical activity | Other | control group |
Primary outcome
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).
6 secondary outcomes
Change in fatigue as assessed with the Parkinson Fatigue Scale (PFS)
Time frame: between baseline and 6 months after baseline
Change in quality of life as assessed with the PDQ-39 scale
Time frame: between baseline and 6 months after baseline
Change in Non-motor symptoms as assessed with the Non Motor Symptoms Scale (NMSS)
Time frame: between baseline and 6 months after baseline
Percentage of patients that complete all four sessions of the program
Time frame: At 3 months ( duration of the program)
Change in physical activity during one week, assessed with the International Physical Activity Questionnaire (IPAQ)
Time frame: between baseline and 6 months after baseline
Change in Motor symptoms as assessed with the MDS-UPDRS-3
Time frame: between baseline and 6 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Carriere, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education to Adapted Physical Activity in people with Parkinson Disease, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in time spent in moderate to vigorous physical activity during one week (time frame: between baseline and 6 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.