Multiple SclerosisACTISEPNCT03928990
Assesment of Physical Activity Level of Patients With Multiple Sclerosis: From Laboratory to Real Life
A study testing ActiGraph accelerometer in people with Multiple Sclerosis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This study aims to assess the feasibility of a protocol determining individual moderate-to-vigorous physical activity (MVPA) thresholds, among multiple sclerosis patients, in routine medical practice. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- ActiGraph accelerometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2019to Jan 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 80 years old
- Multiple sclerosis according to McDonald criteria ;
- Expanded Disability Status Scale (EDSS) between 0 and 6.5 ;
- Patient able to move with or without mechanical assistance.
Who cannot join
- Deterioration of neurological symptomatology within 60 day before enrollment ;
- Changes brought to the multiple sclerosis treatment within 6 months before enrollment ;
- Introduction of a treatment acting on spasticity or fatigue within 30 day before enrollment
- Changes brought to reeducation protocol throughout the duration of the study
- Patient unable to provide an effort equivalent to 3 times the resting metabolic value = 3 Metabolic Equivalent of Task (METs).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Besançon
Besançon, 25000
Yoshimasa Sagawa, PhD, 0033 3 81 21 87 51, ysagawajunior@chu-besancon.fr
Thierry Moulin, MD PhD
About this study
This study aims to assess the feasibility of a protocol determining individual moderate-to-vigorous physical activity (MVPA) thresholds, among multiple sclerosis patients, in routine medical practice.
- Conditions
- Multiple Sclerosis
- Being tested
- ActiGraph accelerometer
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiGraph accelerometerDevice
ActiGraph accelerometer + calibration with Cortex MetaMax3B ergospirometer
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Not described Receives: Device: ActiGraph accelerometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's feeling
Patient's feeling measured at each step of the procedure, measured with Visual Analogique Scale (scored from 0 = not painful to 10 = extremely painful)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start15 Jan 2019
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928990
- Sponsor's protocol ID
- P/2018/376
- Acronym
- ACTISEP
- Status last verified
- Apr 2019
- First submitted
- 24 Apr 2019
- Last updated
- 26 Apr 2019
- 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 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of Physical Activity Level of Patients With Multiple Sclerosis: From Laboratory to Real Life
- ClinicalTrials.gov ID
- NCT03928990
- Acronym / sponsor ID
- ACTISEP / P/2018/376
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 26 Apr 2019 (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.
This study aims to assess the feasibility of a protocol determining individual moderate-to-vigorous physical activity (MVPA) thresholds, among multiple sclerosis patients, in routine medical practice.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Device: ActiGraph accelerometer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 to 80 years old
- Multiple sclerosis according to McDonald criteria ;
- Expanded Disability Status Scale (EDSS) between 0 and 6.5 ;
- Patient able to move with or without mechanical assistance.
Key exclusion criteria (5 listed)
- Deterioration of neurological symptomatology within 60 day before enrollment ;
- Changes brought to the multiple sclerosis treatment within 6 months before enrollment ;
- Introduction of a treatment acting on spasticity or fatigue within 30 day before enrollment
- Changes brought to reeducation protocol throughout the duration of the study
- Patient unable to provide an effort equivalent to 3 times the resting metabolic value = 3 Metabolic Equivalent of Task (METs).
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 |
|---|---|---|
| ActiGraph accelerometerActiGraph accelerometer + calibration with Cortex MetaMax3B ergospirometer | Device | Experimental arm |
Primary outcome
Patient's feeling
Time frame: Day 1
Patient's feeling measured at each step of the procedure, measured with Visual Analogique Scale (scored from 0 = not painful to 10 = extremely painful)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActiGraph accelerometer in people with Multiple Sclerosis, run by Centre Hospitalier Universitaire de Besancon 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: status not confirmed, as of the sponsor's last update on 26 Apr 2019. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoshimasa Sagawa Jr., PhD (00333 81 21 87 51, ysagawajunior@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's feeling (time frame: Day 1). 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 26 Apr 2019.