Interventions Against Fatigue in Patients With Myasthenia Gravis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLeiden University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Aerobic exercise therapy
BehavioralParticipants will follow an aerobic exercise therapy program for 16 weeks.
Cognitive behavioural therapy
BehavioralParticipants will follow an cognitive behavioural therapy program for 12-16 weeks.
Usual care
Other interventionParticipants do not follow a program, but continue with care as usual
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Aerobic exercise therapyOther 1 intervention
Group B: Cognitive behavioural therapyOther 1 intervention
Group C: Usual careOther 1 intervention
Trial outcomes
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).
Time frame
Assessed after 4 weeks and 20 weeks.Secondary outcomes
1
A change in CIS-fatigue in the AET group compared to the CBT group before and after intervention and during follow-up.
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 ≥ 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).
Time frame
Assessed after 20 weeks and 32 weeks.2
A sustained change in CIS-fatigue after AET or CBT intervention at 32 weeks (12 weeks post-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 ≥ 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).
Time frame
Assessed after 32 weeks.3
A long term change in CIS-fatigue after AET or CBT intervention at 52 weeks.
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 ≥ 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).
Time frame
Assessed after 52 weeks.4
The number of completed AET or CBT sessions to investigate participants' compliance with a 16 week AET or CBT program.
Compliance with the AET program: at least 40 sessions (of a total of 48 sessions). Compliance with the CBT program: at least 8 sessions.
Time frame
Assessed after 20 weeks.Sponsors and contacts
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Source ClinicalTrials.gov