Clinical trial · Interventional
Digital Phenotyping and Lifestyle Intervention in Patients with Myasthenia Gravis
Randomized Controlled Trial: Digital Phenotyping and Lifestyle Intervention in Patients with Myasthenia Gravis to Reduce Fatigue
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Myasthenia Gravis (MG) is a chronic autoimmune neurological disorder where an antibody attack of muscle receptors causes fatigable skeletal muscle weakness. In addition to fatigue, several MG patients experience general fatigue. Small supervised studies during 12 weeks of physical exercise interventions have indicated safety and beneficial neuromuscular outcomes in MG patients. Longer and unsupervised studies are required to obtain guidelines for physical activity in MG patients. Further, the development of smart rings enables remote digital supervision of physical activity, sleep, and biological parameters such as heart frequency, number of steps, and temperature. These parameters could add to the lack of biomarkers in MG. The project design is a randomized controlled trial with a lifestyle intervention to improve fatigue in the autoimmune neuromuscular disease Myasthenia Gravis (MG). The intervention includes digital group counseling regarding physical activity, sleep, general health, and digital follow-up with a "smart ring" (OURA).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myasthenia Gravis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Physical activity | Behavioral | — | UNRESOLVED |
| Sleep hygiene | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Observation
- description
- Observation with the OURA ring and no digital meetings. The participants are offered delayed randomization after the study period. This group's outcome from the delayed randomization will be for the exploratory analysis, i.e., not in the primary analysis.
- type
- EXPERIMENTAL
- label
- Physical activity
- description
- 12 weeks of physical activity guidance with short discussions via online group meetings according to a schedule. The participants in this arm will conduct moderate-intensity exercises for at least 150 minutes per week. Brisk walks are the primary choice of activity; alternatively, swimming, cycling, or dancing to the physical exertion according to the Borg scale can be performed.
- interventionNames
- Behavioral: Physical activity
- type
- ACTIVE_COMPARATOR
- label
- Sleep hygiene intervention
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * The MG disease status must be stable for at least six months before entry into the study; thus, the duration of the disease must be at least six months. * Both patients with ocular and generalized MG are allowed to participate. * For practical reasons, participants need to be able to understand fully and communicate in Swedish. Exclusion Criteria: * Participation in another clinical trial in the past 6 months. * Disease duration less than 6 months. * Contraindications to physical activity: unstable coronary syndrome or myocardial infarction within the preceding three months, respiratory failure (vital capacity \< 70% predicted value) or cardiac failure (ejection fraction \< 50% predicted value), concomitant neuromuscular diseases, disabling rheumatological disease (\> 80% disability on the Barthel scale), chronic pain or disabling orthopedic conditions, hospitalization in the last three months for a serious medical or surgical condition, anemia (hematocrit \< 30%), stroke within the previous year. * MG patients already performing moderate-intensity physical activity of 150min or more per week, i.e., one of the target interventions. * Pregnancy.
References
Publications (1)
- DERIVEDBhandage AK, Chen J, Kaminski HJ, Punga AR. Blood and digital biomarkers in MG. Int Rev Neurobiol. 2025;182:205-226. doi: 10.1016/bs.irn.2025.04.030. Epub 2025 May 9. PMID 40675736