NCT05992025Completed
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 · Last updated 30 Mar 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 83 (actual)
- First submitted
- 7 Jun 2023
- Start date
- 10 Jul 2023
- Primary completion date
- 15 Aug 2024
- Lead sponsor
- Uppsala University
- Diseases
- Myasthenia gravis
- NCT number
- NCT05992025
What you commit to
- Study type: Interventional
- Participants enrolled: 83
- From 10 Jul 2023 to the primary completion date, 15 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Disease duration less than 6 months.
Lab values
- 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.
Other
- Participation in another clinical trial in the past 6 months.
- MG patients already performing moderate-intensity physical activity of 150min or more per week, i.e., one of the target interventions.
- Pregnancy.
Who the study is looking for
- 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.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Uppsala University Coordinator of this site? Confirm its status | Uppsala | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.