Myasthenia GravisFIT to ACT-MGNCT06659627

Interventions Against Fatigue in Patients With Myasthenia Gravis

A study testing Aerobic exercise therapy and Cognitive behavioural therapy in people with Myasthenia Gravis and Fatigue, run by Leiden University Medical Center at 1 site in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myasthenia Gravis, Fatigue
What is being tested?: Aerobic exercise therapy and Cognitive behavioural therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteNetherlands
Study dates: 4 Dec 2024to 23 Jan 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 10Show fewer

The patient is already undergoing cognitive behavioural therapy.
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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Leiden University Medical Center
Leiden, South Holland, 2333 ZA

Other trials in Netherlands

About this study

Official title: Fatigue Improvement Through Aerobic Exercise and Cognitive Behavioural Therapy in Patients With Myasthenia Gravis

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.

Read the 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.

Furthermore, a qualitative study will be conducted to explore the experiences of participants in both the AET and CBT groups. Semi-structured interviews, based on a topic list, will be held with 10 participants from each intervention group separately. These interviews will take place within three months after the intervention phase has ended.

Conditions: Myasthenia Gravis, Fatigue
Being tested: Aerobic exercise therapy, Cognitive behavioural therapy, Usual care
Keywords: Myasthenia Gravis, Fatigue, Aerobic Exercise Therapy, Cognitive Behavioural Therapy
Medical subject headings: Myasthenia Gravis, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aerobic exercise therapyBehavioural
Participants will follow an aerobic exercise therapy program for 16 weeks.
Cognitive behavioural therapyBehavioural
Participants will follow an cognitive behavioural therapy program for 12-16 weeks.
Usual careOther
Participants do not follow a program, but continue with care as usual

Study groups in NCT06659627
Study group	Role	What they receive
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). Receives: 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. Receives: 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. Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
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).
Measured: 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).
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).
Measured: Assessed after 32 weeks.
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).
Measured: Assessed after 52 weeks.
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.
Measured: Assessed after 20 weeks.
A change in the use of MG medication before and after AET or CBT intervention, compared to usual care.
Changes in types of medication and changes in dosages of medication.
Measured: Assessed after 20 weeks and 32 weeks.
A change in MG Quality of Life 15-item (MG-QoL 15r) Scale after AET or CBT intervention compared to usual care.
MG-QoL 15r consists of 15 items with a total score of 0-30; a higher score indicating worse health-related quality of life.
Measured: Assessed after 4 weeks, 20 weeks, 32 weeks and 52 weeks.
A clinically relevant change in MG Activities of Daily Living (MG-ADL) Scale after AET or CBT intervention compared to usual care.
MG-ADL consists of 8 items with a total score of 0-24; a higher score indicating more severe disease. ≥2 points change is considered a clinically relevant change.
Measured: Assessed after 4 weeks and 20 weeks.
A clinically relevant change in Quantitative MG (QMG) Scale after AET or CBT intervention compared to usual care
QMG consists of 13 items with a total score of 0-39; a higher score indicating more severe disease. ≥3 points change is considered a clinically relevant change.
Measured: Assessed after 4 weeks and 20 weeks.
Changes in amount of weekly vigorous intensity physical activity, as measured by the number of minutes per week that the heart rate reaches at least 70% of maximum heart rate after AET or CBT intervention compared to usual care.
Measured by a remote activity tracker.
Measured: Assessed after 4 weeks, 20 weeks, 32 weeks and 52 weeks.
A change in cardiorespiratory fitness (CRF) after AET or CBT intervention compared to usual care.
Measured by an aerobic fitness test (Steep Ramp Test (SRT)) measuring the Wpeak.
Measured: Assessed after 4 weeks and 20 weeks.
A change in CIS-activity after AET or CBT intervention compared to usual care.
Checklist Individual Strength (CIS-) activity subscale is a subscale consisting of 3 questions with each question scored on a 7-point Likert scale with a total score of 3-21; a higher score indicating less activity. This subscale is not validated for use as standalone outcome measure in MG and does not have an established cut-off score or threshold for clinical relevance
Measured: Assessed after 4 weeks, 20 weeks, 32 weeks and 52 weeks.
A change in International Physical Activity Questionnaire - Short Form (IPAQ-SF) after AET or CBT intervention compared to usual care.
IPAQ-SF consists of 7 questions; a higher score indicating more strenuous activity.
Measured: Assessed on day 1, after 4 weeks and 20 weeks.
A change in CIS-concentration and -motivation after AET or CBT intervention compared to usual care.
Checklist Individual Strength (CIS-) concentration and motivation subscales are subscales consisting of 5 and 4 questions respectively with each question scored on a 7-point Likert scale; a higher score indicating more concentration problems or lower motivation respectively. These subscales are not validated for use as standalone outcome measures in MG and do not have an established cut-off scores or thresholds for clinical relevance.
Measured: Assessed after 4 weeks, 20 weeks, 32 weeks and 52 weeks.
A change in Hospital Anxiety and Depression Scale (HADS) after AET or CBT intervention compared to usual care.
HADS consists of 14 items divided into two subscales with each question scored on a 4-point Likert scale; a higher score indicating more symptoms. The total score per subscale (anxiety, depression) ranges from 0-21.
Measured: Assessed on day 1, after 4 weeks and 20 weeks.
A change in Visual Analogue Scale (VAS-pain) after AET or CBT intervention compared to usual care.
VAS-pain is a continuous scale with a total score of 0-10; a higher score indicating greater pain intensity.
Measured: Assessed after 4 weeks and 20 weeks.
A change in Pittsburgh Sleep Quality Index (PSQI) after AET or CBT intervention compared to usual care.
PSQI consists of 19 items with a total score of 0-21; a higher score indicating worse sleep quality.
Measured: Assessed after 4 weeks and 20 weeks.
A change in the social interaction subscale of the Sickness Impact Profile (SIP) after AET or CBT intervention compared to usual care.
SIP consists of 136 items that cover 12 health categories. The social interaction category consists of 20 items; a higher score indicating more health-related behavioural problems. The total score of the SIP ranges from 0-100.
Measured: Assessed after 4 weeks and 20 weeks.
A change in EQ-5D-5L after AET or CBT intervention compared to usual care.
The 5-level EQ-5D (EQ-5D-5L) version consists of 25 questions divided into 5 domains and a continuous scale.
Measured: Assessed on day 1, after 4 weeks, 20 weeks, 32 weeks and 52 weeks.
Changes in the relation of fatigue with CRP serum levels at baseline and after AET or CBT intervention compared to usual care.
Measured: Assessed after 4 weeks and 20 weeks.
Changes in the relation of fatigue with AChR antibody serum levels at baseline and after AET or CBT intervention compared to usual care.
Measured: Assessed after 4 weeks and 20 weeks.
Changes in the relation of fatigue with MuSK antibody serum levels at baseline and after AET or CBT intervention compared to usual care.
Measured: Assessed after 4 weeks and 20 weeks.
Changes in the relation of fatigue with muscle MRI parameters at baseline and after AET or CBT intervention compared to usual care.
1. rectus femoris and m. biceps femoris caput longe: fat fraction, cross sectional area (mm2), contractile cross sectional area (mm2), T2 relaxation time (ms), fractional anisotropy (FA) and mean diffusivity (MD).
Optional for up to 10 participants per group.
Measured: Assessed after 4 weeks and 20 weeks.
To record participants' subjective perspectives to qualitatively assess the process and outcome of a 16 week AET or CBT program.
Semi-structured interviews to get insight into the experiences of patients regarding the process of the interventions, interpretation of effects, and explore factors which influence the implementation of the interventions.
Measured: Within 3 months after the intervention phase.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Dec 202423 Jan 2027

First posted26 Oct 2024
Study start4 Dec 2024
Primary completion30 Jun 2026
Study completion23 Jan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Myasthenia GravisStudies of the same condition, open and under way.
More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Three intervention groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06659627
Sponsor's protocol ID: NL85072.058.23
Acronym: FIT to ACT-MG
Status last verified: Jul 2026
First submitted: 15 Oct 2024
Last updated: 8 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
Generalized Myasthenia Gravis
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Ocular Myasthenia Gravis
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 3
A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Ocular Myasthenia Gravis
Recruiting
Holistic Assessment and Remote Digital MONitoring of mYasthenia Gravis Via MyoSense 360
Myasthenia Gravis, Generalized

All Myasthenia Gravis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fatigue Improvement Through Aerobic Exercise and Cognitive Behavioural Therapy in Patients With Myasthenia Gravis
ClinicalTrials.gov ID: NCT06659627
Acronym / sponsor ID: FIT to ACT-MG / NL85072.058.23
Conditions: Myasthenia Gravis, Fatigue
Keywords: Myasthenia Gravis, Fatigue, Aerobic Exercise Therapy, Cognitive Behavioural Therapy
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: Leiden University Medical CenterUniversity, hospital or other
Study start: 4 Dec 2024 (actual)
Primary completion: 30 Jun 2026 (actual)
Study completion: 23 Jan 2027 (estimated)
First posted: 26 Oct 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3
Model description: Three intervention groups

Arm	Type	Receives
Aerobic exercise therapy	Other	Behavioral: Aerobic exercise therapyAET 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).
Cognitive behavioural therapy	Other	Behavioral: Cognitive behavioural therapyThe 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.
Usual care	Other	Other: Usual careParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aerobic exercise therapyParticipants will follow an aerobic exercise therapy program for 16 weeks.	Behavioural	Aerobic exercise therapy
Cognitive behavioural therapyParticipants will follow an cognitive behavioural therapy program for 12-16 weeks.	Behavioural	Cognitive behavioural therapy
Usual careParticipants do not follow a program, but continue with care as usual	Other	Usual care

Primary outcome

A change in CIS-fatigue in the AET and CBT group, compared to UC, before and after intervention.
Time frame: Assessed after 4 weeks and 20 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 ≥ 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).

23 secondary outcomes

A change in CIS-fatigue in the AET group compared to the CBT group before and after intervention and during follow-up.
Time frame: 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).
Time frame: Assessed after 32 weeks.
A long term change in CIS-fatigue after AET or CBT intervention at 52 weeks.
Time frame: Assessed after 52 weeks.
The number of completed AET or CBT sessions to investigate participants' compliance with a 16 week AET or CBT program.
Time frame: Assessed after 20 weeks.
A change in the use of MG medication before and after AET or CBT intervention, compared to usual care.
Time frame: Assessed after 20 weeks and 32 weeks.
A change in MG Quality of Life 15-item (MG-QoL 15r) Scale after AET or CBT intervention compared to usual care.
Time frame: Assessed after 4 weeks, 20 weeks, 32 weeks and 52 weeks.
A clinically relevant change in MG Activities of Daily Living (MG-ADL) Scale after AET or CBT intervention compared to usual care.
Time frame: Assessed after 4 weeks and 20 weeks.
A clinically relevant change in Quantitative MG (QMG) Scale after AET or CBT intervention compared to usual care
Time frame: Assessed after 4 weeks and 20 weeks.
Changes in amount of weekly vigorous intensity physical activity, as measured by the number of minutes per week that the heart rate reaches at least 70% of maximum heart rate after AET or CBT intervention compared to usual care.
Time frame: Assessed after 4 weeks, 20 weeks, 32 weeks and 52 weeks.
A change in cardiorespiratory fitness (CRF) after AET or CBT intervention compared to usual care.
Time frame: Assessed after 4 weeks and 20 weeks.
A change in CIS-activity after AET or CBT intervention compared to usual care.
Time frame: Assessed after 4 weeks, 20 weeks, 32 weeks and 52 weeks.
A change in International Physical Activity Questionnaire - Short Form (IPAQ-SF) after AET or CBT intervention compared to usual care.
Time frame: Assessed on day 1, after 4 weeks and 20 weeks.
A change in CIS-concentration and -motivation after AET or CBT intervention compared to usual care.
Time frame: Assessed after 4 weeks, 20 weeks, 32 weeks and 52 weeks.
A change in Hospital Anxiety and Depression Scale (HADS) after AET or CBT intervention compared to usual care.
Time frame: Assessed on day 1, after 4 weeks and 20 weeks.
A change in Visual Analogue Scale (VAS-pain) after AET or CBT intervention compared to usual care.
Time frame: Assessed after 4 weeks and 20 weeks.
A change in Pittsburgh Sleep Quality Index (PSQI) after AET or CBT intervention compared to usual care.
Time frame: Assessed after 4 weeks and 20 weeks.
A change in the social interaction subscale of the Sickness Impact Profile (SIP) after AET or CBT intervention compared to usual care.
Time frame: Assessed after 4 weeks and 20 weeks.
A change in EQ-5D-5L after AET or CBT intervention compared to usual care.
Time frame: Assessed on day 1, after 4 weeks, 20 weeks, 32 weeks and 52 weeks.
Changes in the relation of fatigue with CRP serum levels at baseline and after AET or CBT intervention compared to usual care.
Time frame: Assessed after 4 weeks and 20 weeks.
Changes in the relation of fatigue with AChR antibody serum levels at baseline and after AET or CBT intervention compared to usual care.
Time frame: Assessed after 4 weeks and 20 weeks.
Changes in the relation of fatigue with MuSK antibody serum levels at baseline and after AET or CBT intervention compared to usual care.
Time frame: Assessed after 4 weeks and 20 weeks.
Changes in the relation of fatigue with muscle MRI parameters at baseline and after AET or CBT intervention compared to usual care.
Time frame: Assessed after 4 weeks and 20 weeks.
To record participants' subjective perspectives to qualitatively assess the process and outcome of a 16 week AET or CBT program.
Time frame: Within 3 months after the intervention phase.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
Individual participant dataSharing planned: No

Related trials for Myasthenia Gravis

Active, not recruitingPhase 3
An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
Generalized Myasthenia Gravis
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Ocular Myasthenia Gravis
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 3
A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Ocular Myasthenia Gravis
Recruiting
Holistic Assessment and Remote Digital MONitoring of mYasthenia Gravis Via MyoSense 360
Myasthenia Gravis, Generalized

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Martijn R. Tannemaat, MD, PhD principal investigator

Leiden University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic exercise therapy and Cognitive behavioural therapy in people with Myasthenia Gravis and Fatigue, run by Leiden University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A change in CIS-fatigue in the AET and CBT group, compared to UC, before and after intervention. (time frame: Assessed after 4 weeks and 20 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06659627.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.