Interventions Against Fatigue in Patients With Myasthenia Gravis

NCT06659627 | Recruiting

• 1 other identifier: NL85072.058.23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective assessor-blinded randomized clinical trial investigating the effect of aerobic exercise therapy or cognitive behavioural therapy on fatigue in patients with myasthenia gravis.

Conditions

Myasthenia Gravis; Fatigue

Keywords

Myasthenia Gravis; Fatigue; Aerobic Exercise Therapy; Cognitive Behavioural Therapy

Outcome Measures

Primary Outcomes (1)

• A change in CIS-fatigue in the AET and CBT group, compared to UC, before and after intervention.

  Fatigue measured on the Checklist Individual Strength (CIS-) fatigue subscale. The CIS-fatigue consists of eight questions on fatigue experienced during the previous two weeks. Each question is scored on a 7-point Likert scale and a score ≥ 27 indicates increased fatigue and a score ≥ 35 indicates severe fatigue. A higher score means more severe fatigue. A decline of ≥8 is considered clinically relevant. The total score of the fatigue subscale ranges from 8-56 (the total score of the CIS questionnaire ranges from 20-140).

  Assessed after 4 weeks and 20 weeks.

Secondary Outcomes (23)

• A change in CIS-fatigue in the AET group compared to the CBT group before and after intervention and during follow-up.

  Assessed after 20 weeks and 32 weeks.

• A sustained change in CIS-fatigue after AET or CBT intervention at 32 weeks (12 weeks post-intervention).

  Assessed after 32 weeks.

• A long term change in CIS-fatigue after AET or CBT intervention at 52 weeks.

  Assessed after 52 weeks.

• The number of completed AET or CBT sessions to investigate participants' compliance with a 16 week AET or CBT program.

  Assessed after 20 weeks.

• A change in the use of MG medication before and after AET or CBT intervention, compared to usual care.

  Assessed after 20 weeks and 32 weeks.

Study Arms (3)

Aerobic exercise therapy

OTHER

AET will consist of three weekly sessions of aerobic workouts on a bicycle ergometer for a period of 16 weeks. The first training session will be supervised by an experienced physical therapist at the LUMC. Subsequently, participants will perform the remaining workouts at home. One session per week will be carried out independently at home. The other two sessions will be digitally supervised via a digital connection by students, who will be trained and supervised by an experienced physical therapist. During the intervention, training intensity will be adjusted based on the participant's rate of perceived exertion (Borg Rating of Perceived Exertion (RPE) scale).

Behavioral: Aerobic exercise therapy

Cognitive behavioural therapy

OTHER

The entire CBT program will be followed digitally through an online platform and will span 12-16 weeks. The program will be tailored to the individual participants' needs and preferences. Every week or every two weeks, the psychologist provides feedback on the finished sessions and gives new assignments. If necessary, the psychologist will contact a participant by phone for additional support.

Behavioral: Cognitive behavioural therapy

Usual care

OTHER

Participants are not restricted in their activities, but will be instructed not to start a new exercise or cognitive behavioural program. Chronic physical therapy and psychological counselling in the context of usual care are allowed to continue.

Other: Usual care

Interventions

Aerobic exercise therapy BEHAVIORAL

Participants will follow an aerobic exercise therapy program for 16 weeks.

Aerobic exercise therapy

Cognitive behavioural therapy BEHAVIORAL

Participants will follow an cognitive behavioural therapy program for 12-16 weeks.

Cognitive behavioural therapy

Usual care OTHER

Participants do not follow a program, but continue with care as usual

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• A clinical diagnosis of myasthenia gravis (ocular or generalized) as defined by the Dutch national guideline (category "definite" or "probable" MG).
• The diagnosis of MG was made at least a year ago and the MG is stable, as determined by the treating neurologist.
• Patients who use the following medication: prednisone, intravenous immunoglobulin (IVIg), complement inhibitor (e.g. Eculizumab), neonatal Fc receptor (FcRn) inhibitor (e.g. Efgartigimod) have been on a stable dosing regimen for at least one month.
• MGFA Clinical Classification of disease severity I-IV.
• Clinically relevant fatigue (a score ≥ 27 on the CIS-fatigue).
• Ability to walk and exercise.
• Ability to understand the requirements of the study and provide written informed consent.

You may not qualify if:

• The patient is unable to fill out the study questionnaires or be interviewed in Dutch, or is unable to undergo the tests needed for the study, or is unable to give informed consent for participation in the study.
• The patient is unable to use the activity tracker and digital infrastructure provided.
• Co-morbidity interfering with AET or affecting exercise response and exercise capacity, including severe cardiopulmonary co-morbidity, as assessed by the investigator.
• Co-morbidity interfering with CBT, a clinical diagnosis of depression or a score ≥12 on the Hospital Anxiety and Depression Scale (HADS) depression subscale, as assessed by the investigator.
• Use of beta blockers.
• The patient is already engaged in strenuous exercise more than twice a week.
• The patient is already undergoing cognitive behavioural therapy.
• Pregnancy or intention to become pregnant during the study.
• \- In case of uncertainty about the MRI-contraindications, the MR-safety commission of the Radiology department will decide whether this subject can be included in the study or not.

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

RECRUITING

MeSH Terms

Conditions

Myasthenia Gravis; Fatigue

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Martijn R. Tannemaat, MD, PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martijn R Tannemaat, MD, PhD

CONTACT

+31715262197; m.r.tannemaat@lumc.nl

Yvonne JM Campman, MD

CONTACT

+31715262118; y.j.m.campman@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The researchers are blinded. After 32 weeks of the last patient the researchers will be unblinded and the study will proceed as an open-label extension study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Three intervention groups

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 26, 2024
• Study Start: December 4, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)