Interventions Against Fatigue in Patients with Myasthenia Gravis

Trial Title: Interventions Against Fatigue in Patients with Myasthenia Gravis

NCT ID: NCT06659627

Condition: Myasthenia Gravis
Fatigue

Conditions: Official terms:
Myasthenia Gravis
Muscle Weakness
Fatigue

Conditions: Keywords:
Myasthenia Gravis
Fatigue
Aerobic Exercise Therapy
Cognitive Behavioural Therapy

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Three intervention groups

Primary purpose: Treatment

Masking: Double (Investigator, Outcomes Assessor)

Masking description: 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.

Intervention:

Intervention type: Behavioral
Intervention name: Aerobic exercise therapy
Description: Participants will follow an aerobic exercise therapy program for 16 weeks.
Arm group label: Aerobic exercise therapy

Intervention type: Behavioral
Intervention name: Cognitive behavioural therapy
Description: Participants will follow an cognitive behavioural therapy program for 12-16 weeks.
Arm group label: Cognitive behavioural therapy

Intervention type: Other
Intervention name: Usual care
Description: Participants do not follow a program, but continue with care as usual
Arm group label: Usual care

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.

Detailed description: This study will be a prospective assessor-blinded randomized controlled trial comparing AET and CBT with usual care (UC). For an individual participant, the overall study duration will be 52 weeks with a total intervention duration of 16 weeks. After 32 and 52 weeks the investigators will analyse the data from the activity tracker and approach each participant to digitally complete a total of three questionnaires. After 32 weeks the researchers will be unblinded and the study will proceed as an open-label extension study. After signing the informed consent form, an activity tracker (Withings Pulse HR) will be provided to all participants. After a four week observation period to evaluate the baseline levels of daily activity, participants will visit the LUMC for baseline measurements and a blood test. After obtaining these baseline characteristics, all participants will be randomly assigned to either AET, CBT or UC. Participants in the AET group start with an intake meeting with a physical therapist. 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). During each session, the participant is also able to adjust the wattage of that specific training. Training activity and execution will be monitored remotely using the bicycle ergometer and the activity tracker. Adherence and reasons for possible non-adherence will be monitored by the students. Outcome measures will be collected on follow-up immediately after the 16-week intervention. Participants in the CBT group start with an online intake meeting with a psychologist. 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. Outcome measures will be collected on follow-up immediately after the 16-week intervention. The outcome measures of the participants in the UC group are obtained after the four week observation period and after 20 weeks follow-up. 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. After the 32-week follow-up, the participants in the UC group have the option to follow a modified version of the AET or CBT interventions without supervision. Participants will be given the option to undergo a quantitative muscle MRI of the upper legs. The MRI is additional and not mandatory to participate in the study. The investigators will include a maximum of 10 participants per group. Participants will undergo the MRI twice: before intervention at baseline and after intervention at 20 weeks follow-up.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Age ≥ 18 years 2. A clinical diagnosis of myasthenia gravis (ocular or generalized) with the typical fluctuating muscle weakness and at least one of the following: - a positive serologic test for AChR or MuSK antibodies; - an abnormal electrodiagnostic test: repetitive nerve stimulation (RNS) or single-fiber electromyography (SFEMG). 3. The diagnosis of MG was made at least a year ago and the MG is stable, as determined by the treating neurologist. 4. 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. 5. MGFA Clinical Classification of disease severity I-IV. 6. Clinically relevant fatigue (a score ≥ 35 on the CIS-fatigue). 7. Ability to walk and exercise. 8. Ability to understand the requirements of the study and provide written informed consent. Exclusion Criteria: 1. 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. 2. The patient is unable to use the activity tracker and digital infrastructure provided. 3. Co-morbidity interfering with AET or affecting exercise response and exercise capacity, including severe cardiopulmonary co-morbidity, as assessed by the investigator. 4. Co-morbidity interfering with CBT, a clinical diagnosis of depression or a score ≥12 on the Hospital Anxiety and Depression Scale (HADS), as assessed by the investigator. 5. Use of beta blockers. 6. The patient is already engaged in strenuous exercise more than twice a week. 7. The patient is already undergoing cognitive behavioural therapy. 8. Pregnancy or intention to become pregnant during the study. Exclusion Criterion for muscle MRI 1. Inability to undergo MRI. - 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Leiden University Medical Center

Address:
City: Leiden
Zip: 2333 ZA
Country: Netherlands

Start date: October 2024

Completion date: September 2026

Lead sponsor:
Agency: Leiden University Medical Center
Agency class: Other

Source: Leiden University Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06659627