NCT02066519

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 19, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2018

Completed
Last Updated

August 13, 2018

Status Verified

November 1, 2017

Enrollment Period

3.3 years

First QC Date

January 13, 2014

Last Update Submit

August 10, 2018

Conditions

Myasthenia Gravis

Keywords

Myasthenia gravisphysical exercisequality of lifemuscular performancefatigability

Outcome Measures

Primary Outcomes (1)

  • Change in the quality of life between M3 and M6 by MGQOL score

    M3 and M6

Secondary Outcomes (11)

  • Muscular strength

    M3, M6 and M9

  • Frequency of MG exacerbations

    6 MONTHS

  • Frequency and severity of cardiovascular side-effects

    6 MONTHS

  • Cumulative dose of steroids within the 3 months of the exercise programme

    6 MONTHS

  • Doses of anticholinesterasic and steroids at 3, 6 and 9 months

    M3, M6 and M9

  • +6 more secondary outcomes

Study Arms (2)

Physical exercise arm

EXPERIMENTAL

Arm with physical exercise on rowing machine between M3 and M6

Behavioral: Physical exercise programme using a rowing machine

Control arm

NO INTERVENTION

Arm with standard medical care without additional physical exercise

Interventions

Physical exercise programme using a rowing machineBEHAVIORAL

3 sessions per week of individualized physical training using a rowing machine during 3 months.

Physical exercise arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 %
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICU and medical surgery department, Raymond Poincaré Hospital

Garches, Hauts-de-Seine, 92380, France

Location

Related Publications (2)

  • 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.

    PMID: 34304969DERIVED

  • Birnbaum 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.

    PMID: 29347991DERIVED

MeSH Terms

Conditions

Myasthenia GravisMotor Activity

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • Tarek SHARSHAR, MD, PhD

    ICU and medical surgery Service, Raymond Poincaré Hospital, 92380 Garches, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2014

First Posted

February 19, 2014

Study Start

October 1, 2014

Primary Completion

January 10, 2018

Study Completion

April 6, 2018

Last Updated

August 13, 2018

Record last verified: 2017-11

Locations

FR(1)