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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02066519
First received: January 13, 2014
Last updated: July 17, 2014
Last verified: November 2013
  Purpose

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.


Condition Intervention
Myasthenia Gravis
Behavioral: Physical exercise programme using a rowing machine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Change in the quality of life between M3 and M6 by MGQOL score [ Time Frame: M3 and M6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Muscular strength [ Time Frame: M3, M6 and M9 ] [ Designated as safety issue: No ]
    Muscular strength (before exercise period, after exercise period and 3 months after)

  • Frequency of MG exacerbations [ Time Frame: 6 MONTHS ] [ Designated as safety issue: Yes ]
  • Frequency and severity of cardiovascular side-effects [ Time Frame: 6 MONTHS ] [ Designated as safety issue: Yes ]
  • Cumulative dose of steroids within the 3 months of the exercise programme [ Time Frame: 6 MONTHS ] [ Designated as safety issue: No ]
  • Doses of anticholinesterasic and steroids at 3, 6 and 9 months [ Time Frame: M3, M6 and M9 ] [ Designated as safety issue: No ]
  • Psychological status (STAI, BECK, MINI et SEI scales) at 3, 6 and 9 months [ Time Frame: M3, M6 and M9 ] [ Designated as safety issue: No ]
  • Plasma levels of pro- and anti-inflammatory cytokines at 9 months [ Time Frame: M9 ] [ Designated as safety issue: No ]
  • Muscular fatigability [ Time Frame: M3, M6 and M9 ] [ Designated as safety issue: No ]
    fatigability (before exercise period, after exercise period and 3 months after)

  • Muscular endurance [ Time Frame: M3, M6 and M9 ] [ Designated as safety issue: No ]
    muscular endurance (before exercise period, after exercise period and 3 months after)

  • Severity of MG exacerbations [ Time Frame: 6 MONTHS ] [ Designated as safety issue: Yes ]
  • Frequency and severity of respiratory side-effects [ Time Frame: 6 MONTHS ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 44
Study Start Date: September 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical exercise arm
Arm with physical exercise on rowing machine between D97 and D104.
Behavioral: Physical exercise programme using a rowing machine
3 sessions per week of individualized physical training using a rowing machine during 3 months.
No Intervention: Control arm
Arm with standard medical care without additional physical exercise

Detailed Description:

A two centres 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 with prednisone and/or azathioprine.

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 daily exercise during three months. The daily exercise will be performed on a rowing machine that will be adapted to the patient's own physical ability.

Daily 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 daily exercise.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient with generalized MG of stage II or III according to the MGFA classification, stabilized for at least 6 months by prednisone and/or azathioprine. Criteria for MG are either

    • positive dosage of ant-RACh or MuSK auto-antibodies;
    • musculoskeletal deficit + fluctuating motor deficit + 10% decrement on electroneuromyography + improvement with acetylcholinesterase inhibitor
  2. Patient > 18 and < 60 years old
  3. Patient having an health insurance
  4. Informed written consent

Exclusion Criteria:

  1. Patients under particular protection
  2. Enrolment in another biomedical research in the last 3 months;
  3. Patients with a regular physical training > 1H30 per week
  4. 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 < 80 %
    • 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%)

4) MGFA grade I, grade IV or V 5) Severe cognitive impairment 6) MGQOL-15 below 30/60

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02066519

Contacts
Contact: Tarek SHARSHAR, MD, PHD + 33 (0) 1 47 10 77 82 tarek.sharshar@rpc.aphp.fr

Locations
France
ICU and medical surgery department, Raymond Poincaré Hospital Not yet recruiting
Garches, Hauts-de-Seine, France, 92380
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Tarek SHARSHAR, MD, PhD ICU and medical surgery Service, Raymond Poincaré Hospital, 92380 Garches, France
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02066519     History of Changes
Other Study ID Numbers: P111106
Study First Received: January 13, 2014
Last Updated: July 17, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Myasthenia gravis
physical exercise
quality of life
muscular performance
fatigability

Additional relevant MeSH terms:
Myasthenia Gravis
Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 22, 2014