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Completed

NCT Number: NCT02066519

Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICU and medical surgery department, Raymond Poincaré Hospital

Garches, Hauts-de-Seine, 92380, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Physical exercise programme using a rowing machine

Behavioral

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

Primary outcomes

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

    Time frame: M3 and M6

Secondary outcomes

  1. Muscular strength

    Time frame: M3, M6 and M9

    Muscular strength (before exercise period, after exercise period and 3 months after)

  2. Frequency of MG exacerbations

    Time frame: 6 MONTHS

  3. Frequency and severity of cardiovascular side-effects

    Time frame: 6 MONTHS

  4. Cumulative dose of steroids within the 3 months of the exercise programme

    Time frame: 6 MONTHS

  5. Doses of anticholinesterasic and steroids at 3, 6 and 9 months

    Time frame: M3, M6 and M9

  6. Psychological status (STAI, BECK, MINI et SEI scales) at 3, 6 and 9 months

    Time frame: M3, M6 and M9

  7. Plasma levels of pro- and anti-inflammatory cytokines at 9 months

    Time frame: M9

  8. Muscular fatigability

    Time frame: M3, M6 and M9

    fatigability (before exercise period, after exercise period and 3 months after)

  9. Muscular endurance

    Time frame: M3, M6 and M9

    muscular endurance (before exercise period, after exercise period and 3 months after)

  10. Severity of MG exacerbations

    Time frame: 6 MONTHS

  11. Frequency and severity of respiratory side-effects

    Time frame: 6 MONTHS

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: MGEX

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 19, 2014
Registry last updated
Aug 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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