Myasthenia GravisMGEXNCT02066519
Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis
A study testing Physical exercise programme using a rowing machine in people with Myasthenia Gravis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to demonstrate that a 3 months physical exercise programme improves the Quality of Life of patients with generalized Myasthenia Gravis (MG) stabilized since at least 6 months under prednisone and/or azathioprine. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- Physical exercise programme using a rowing machine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to 6 Apr 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with generalized MG of stage II or III according to the MGFA classification, stabilized for at least 6 months. Criteria for MG are either
- positive dosage of ant-RACh or MuSK auto-antibodies;
- If absent, myasthenic symptoms decrement> 10% in EMNG and test the positive prostigmine
- Patient ≥ 18 and ≤ 70 years old
- Patient having an health insurance
- Informed written consent
Who cannot join
- Patients under particular protection
- Enrolment in another biomedical research in the last 3 months;
- Patients for whom physical practice is contra-indicated because of :
- Unstable coronary Syndrome or myocardial infarction within the past 3 months
- Heart failure with systolic ejection fraction < 50 %
- Respiratory failure defined by a vital capacity (CV) < 70 %
Show all 15Show fewer
- Stroke
- Other neuromuscular pathology
- Disabling Rheumatologic disease (> 80 % disability according to the Barthel scale)
- Chronic Pain or disabling orthopaedic conditions
- Hospitalization in the last 3 months for a serious medical or surgical condition
- Anemia (hematocrit < 30%)
- MGFA grade I, grade IV or V
- Severe cognitive impairment
- MGQOL-15 below 15/60
Trial locations and contacts
1 site in 1 country.
France1 site
ICU and medical surgery department, Raymond Poincaré Hospital
Garches, Hauts-de-Seine, 92380
About this study
The purpose of this study is to demonstrate that a 3 months physical exercise programme improves the Quality of Life of patients with generalized Myasthenia Gravis (MG) stabilized since at least 6 months under prednisone and/or azathioprine.
Read the detailed description
Three centers randomized simple blind clinical trial whose objective is to assess the efficacy on QoL improvement, and the tolerance of physical exercise over a period of 3 months in patients with generalized MG who have been stabilized since at least 6 months.
During the 3 months pre-inclusion phase, the characteristics of MG will be collected. Physical activity and performance will be assessed monthly.
MGQOL15 will be assessed at inclusion.
Patients will be randomized in either intervention arm or control arm.
The intervention arm will consist of three sessions exercise per week during three months. The daily exercise will be performed on a rowing machine that will be adapted to the patient's own physical ability.
Physical activity will be measured with the help of an actimeter.
Once a month, MG evolution and tolerance to exercise will be assessed and MG treatment dose will be collected.
Exercise will be interrupted in case of MG exacerbation.
Quality of life and psychological status will be assessed at 3, 6 and 9 months.
Plasma levels of pro and anti-inflammatory cytokines will be measured at 3, 6 and 9 months in order to assess the effects of exercise on immune response.
Patients enrolled in the control arm will benefit from the same follow-up but will not have exercise.
- Conditions
- Myasthenia Gravis
- Being tested
- Physical exercise programme using a rowing machine
- Keywords
- Myasthenia gravis, physical exercise, quality of life, muscular performance, fatigability
- Medical subject headings
- Myasthenia Gravis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise programme using a rowing machineBehavioural
3 sessions per week of individualized physical training using a rowing machine during 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Physical exercise arm | Experimental | Arm with physical exercise on rowing machine between M3 and M6 Receives: Behavioral: Physical exercise programme using a rowing machine |
| Control arm | No intervention | Arm with standard medical care without additional physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the quality of life between M3 and M6 by MGQOL score
Measured: M3 and M6
Secondary outcomes (11)
Muscular strength
Muscular strength (before exercise period, after exercise period and 3 months after)
Measured: M3, M6 and M9
Frequency of MG exacerbations
Measured: 6 MONTHS
Frequency and severity of cardiovascular side-effects
Measured: 6 MONTHS
Cumulative dose of steroids within the 3 months of the exercise programme
Measured: 6 MONTHS
Doses of anticholinesterasic and steroids at 3, 6 and 9 months
Measured: M3, M6 and M9
Psychological status (STAI, BECK, MINI et SEI scales) at 3, 6 and 9 months
Measured: M3, M6 and M9
Plasma levels of pro- and anti-inflammatory cytokines at 9 months
Measured: M9
Muscular fatigability
fatigability (before exercise period, after exercise period and 3 months after)
Measured: M3, M6 and M9
Muscular endurance
muscular endurance (before exercise period, after exercise period and 3 months after)
Measured: M3, M6 and M9
Severity of MG exacerbations
Measured: 6 MONTHS
Frequency and severity of respiratory side-effects
Measured: 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startOct 2014
- Primary completion10 Jan 2018
- Study completion6 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tarek SHARSHAR, MD, PhD, Principal investigator, ICU and medical surgery Service, Raymond Poincaré Hospital, 92380 Garches, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066519
- Sponsor's protocol ID
- P111106
- Acronym
- MGEX
- Status last verified
- Nov 2017
- First submitted
- 13 Jan 2014
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Birnbaum S, Porcher R, Portero P, Clair B, Demeret S, Eymard B, Gargiulo M, Louet E, Berrih-Aknin S, Le Panse R, Aegerter P, Hogrel JY, Sharshar T; MGEX Study Group. Home-based exercise in autoimmune myasthenia gravis: A randomized controlled trial. Neuromuscul Disord. 2021 Aug;31(8):726-735. doi: 10.1016/j.nmd.2021.05.002. Epub 2021 May 27.
PubMed 34304969Birnbaum S, Hogrel JY, Porcher R, Portero P, Clair B, Eymard B, Demeret S, Bassez G, Gargiulo M, Louet E, Berrih-Aknin S, Jobic A, Aegerter P, Thoumie P, Sharshar T; MGEX Study Group. The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trial. Trials. 2018 Jan 18;19(1):49. doi: 10.1186/s13063-017-2433-2.
PubMed 29347991
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT02066519
- Acronym / sponsor ID
- MGEX / P111106
- Conditions
- Myasthenia Gravis
- Keywords
- Myasthenia gravis, physical exercise, quality of life, muscular performance, fatigability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 6 Apr 2018 (actual)
- First posted
- 19 Feb 2014 (estimated)
- 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.
The purpose of this study is to demonstrate that a 3 months physical exercise programme improves the Quality of Life of patients with generalized Myasthenia Gravis (MG) stabilized since at least 6 months under prednisone and/or azathioprine.
Detailed description
Three centers randomized simple blind clinical trial whose objective is to assess the efficacy on QoL improvement, and the tolerance of physical exercise over a period of 3 months in patients with generalized MG who have been stabilized since at least 6 months.
During the 3 months pre-inclusion phase, the characteristics of MG will be collected. Physical activity and performance will be assessed monthly.
MGQOL15 will be assessed at inclusion.
Patients will be randomized in either intervention arm or control arm.
The intervention arm will consist of three sessions exercise per week during three months. The daily exercise will be performed on a rowing machine that will be adapted to the patient's own physical ability.
Physical activity will be measured with the help of an actimeter.
Once a month, MG evolution and tolerance to exercise will be assessed and MG treatment dose will be collected.
Exercise will be interrupted in case of MG exacerbation.
Quality of life and psychological status will be assessed at 3, 6 and 9 months.
Plasma levels of pro and anti-inflammatory cytokines will be measured at 3, 6 and 9 months in order to assess the effects of exercise on immune response.
Patients enrolled in the control arm will benefit from the same follow-up but will not have exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical exercise arm | Experimental | Behavioral: Physical exercise programme using a rowing machineArm with physical exercise on rowing machine between M3 and M6 |
| Control arm | No intervention | –Arm with standard medical care without additional physical exercise |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with generalized MG of stage II or III according to the MGFA classification, stabilized for at least 6 months. Criteria for MG are either
- Patient ≥ 18 and ≤ 70 years old
- Patient having an health insurance
- Informed written consent
Key exclusion criteria (15 listed)
- Patients under particular protection
- Enrolment in another biomedical research in the last 3 months;
- Patients for whom physical practice is contra-indicated because of :
- MGFA grade I, grade IV or V
- Severe cognitive impairment
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 |
|---|---|---|
| Physical exercise programme using a rowing machine3 sessions per week of individualized physical training using a rowing machine during 3 months. | Behavioural | Physical exercise arm |
Primary outcome
Change in the quality of life between M3 and M6 by MGQOL score
Time frame: M3 and M6
11 secondary outcomes
Muscular strength
Time frame: M3, M6 and M9
Frequency of MG exacerbations
Time frame: 6 MONTHS
Frequency and severity of cardiovascular side-effects
Time frame: 6 MONTHS
Cumulative dose of steroids within the 3 months of the exercise programme
Time frame: 6 MONTHS
Doses of anticholinesterasic and steroids at 3, 6 and 9 months
Time frame: M3, M6 and M9
Psychological status (STAI, BECK, MINI et SEI scales) at 3, 6 and 9 months
Time frame: M3, M6 and M9
Plasma levels of pro- and anti-inflammatory cytokines at 9 months
Time frame: M9
Muscular fatigability
Time frame: M3, M6 and M9
Muscular endurance
Time frame: M3, M6 and M9
Severity of MG exacerbations
Time frame: 6 MONTHS
Frequency and severity of respiratory side-effects
Time frame: 6 MONTHS
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 13 Aug 2018.
- Derived from this study: PubMed 34304969Birnbaum S, Porcher R, Portero P, Clair B, Demeret S, Eymard B, Gargiulo M, Louet E, Berrih-Aknin S, Le Panse R, Aegerter P, Hogrel JY, Sharshar T; MGEX Study Group. Home-based exercise in autoimmune myasthenia gravis: A randomized controlled trial. Neuromuscul Disord. 2021 Aug;31(8):726-735. doi: 10.1016/j.nmd.2021.05.002. Epub 2021 May 27.
- Derived from this study: PubMed 29347991Birnbaum S, Hogrel JY, Porcher R, Portero P, Clair B, Eymard B, Demeret S, Bassez G, Gargiulo M, Louet E, Berrih-Aknin S, Jobic A, Aegerter P, Thoumie P, Sharshar T; MGEX Study Group. The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trial. Trials. 2018 Jan 18;19(1):49. doi: 10.1186/s13063-017-2433-2.
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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.
Tarek SHARSHAR, MD, PhD principal investigator
ICU and medical surgery Service, Raymond Poincaré Hospital, 92380 Garches, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise programme using a rowing machine in people with Myasthenia Gravis, run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 15 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 13 Aug 2018. 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?
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 the quality of life between M3 and M6 by MGQOL score (time frame: M3 and M6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02066519, which also lists 2 linked publications.
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 13 Aug 2018.