Myasthenia GravisDIG-MGNCT05992025
Digital Phenotyping and Lifestyle Intervention in Patients with Myasthenia Gravis
A study testing Physical activity and Sleep hygiene in people with Myasthenia Gravis, run by Uppsala University at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- Physical activity and Sleep hygiene
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteSweden
- Study dates
- 10 Jul 2023to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial: Digital Phenotyping and Lifestyle Intervention in Patients with Myasthenia Gravis to Reduce Fatigue
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).
Read the detailed description
The cohort is Myasthenia Gravis (MG) patients in Sweden. The primary research question is: can digital lifestyle intervention in an online-group format improve fatigue as measured by MG-ADL in MG patients by at least 30%? Secondary research question: can lifestyle intervention improve fatigue as measured by FSS in MG by at least 30%?
The primary outcome measure is MG-ADL; the secondary outcome measures include general fatigue (fatigue severity scale and Chalder´s fatigue scale). Exploratory outcome measures include OURA-ring-based markers, including heart rate variability, temperature fluctuations, and sleep and activity parameters. These will be collected throughout the entire study period for 30 weeks.
Analysis of serum biomarkers miR-150-5p and miR-30e-5p and inflammatory proteins found upregulated in MG will be included. Clinical data at baseline: antibody status, electrophysiology, MG Composite Scale (MGC), and clinical data at follow-up visits (medications, MGC), etc., are extracted from the medical charts and the Swedish MG registry
Inclusion criteria:
- An MG diagnosis for at least six months before entry into the study.
- Both patients with ocular and generalized MG are allowed to participate.
- For practical reasons, participants need to understand 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 a moderate-intensity physical activity of 150min or more per week, i.e., one of the target interventions.
- Pregnancy.
Each participant is enrolled in the study for 7 months, and 26 persons are randomized to one of the following 3 groups:
- Group 1; no intervention, observation with the OURA ring.
- Group 2: 12 weeks of physical activity guidance with short discussions via digital meetings regularly. They will conduct at least 150 minutes per week of moderate-intensity exercises. 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.
- Group 3: 12 weeks of sleep exercises. The lifestyle intervention of sleep will be delivered via an online group, with recommended home practices between sessions. Topics covered will include sleep education, sleep hygiene, and practices to improve sleep quality.
The study is digital and will use the platform "minforskning.se", which is validated according to GCP-GAMP5 and has the potential to collect digital consent forms.
- Conditions
- Myasthenia Gravis
- Being tested
- Physical activity, Sleep hygiene
- Keywords
- lifestyle intervention, fatigue, OURA, physical activity
- Medical subject headings
- Myasthenia Gravis, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
Intervention with physical activity more than 150 minutes of medium to high intensity per week.
Sleep hygieneBehavioural
Intervention with sleep hygiene to optimize sleep duration and quality.
| Study group | Role | What they receive |
|---|---|---|
| Observation | No intervention | 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. |
| Physical activity | Experimental | 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. Receives: Behavioral: Physical activity |
| Sleep hygiene intervention | Active comparator | 12 weeks of sleep exercises. The lifestyle intervention of sleep will be delivered via an online group, with recommended home practices between sessions. Topics covered will include sleep education, sleep hygiene, and practices to improve sleep quality. Receives: Behavioral: Sleep hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myasthenia Gravis-Activities of Daily Living (MG-ADL)
Subjective assessment of MG-related fatiguability. A person's score can range from zero (normal) to 24 (most severe).
Measured: 7 months
Secondary outcomes (2)
Fatigue Severity Scale (FSS)
The Fatigue Severity Scale (FSS) ranges from 0 (least fatigue) to 63 (maximum fatigue).
Measured: 7 months
Chalder Fatigue Scale
The Chalder Fatigue Scale ranges from 0 (least fatigue) to 33 (maximum fatigue)
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start10 Jul 2023
- Primary completion15 Aug 2024
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Prospective, randomized controlled trial, parallel-group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Rostedt Punga, MD, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992025
- Sponsor's protocol ID
- 2023-01455-01
- Other IDs
- 2023
- Acronym
- DIG-MG
- Status last verified
- Mar 2025
- First submitted
- 7 Jun 2023
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not relevant.
Publications
Bhandage 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.
PubMed 40675736
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial: Digital Phenotyping and Lifestyle Intervention in Patients with Myasthenia Gravis to Reduce Fatigue
- ClinicalTrials.gov ID
- NCT05992025
- Acronym / sponsor ID
- DIG-MG / 2023-01455-01
- Conditions
- Myasthenia Gravis
- Keywords
- lifestyle intervention, fatigue, OURA, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 15 Aug 2023 (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.
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).
Detailed description
The cohort is Myasthenia Gravis (MG) patients in Sweden. The primary research question is: can digital lifestyle intervention in an online-group format improve fatigue as measured by MG-ADL in MG patients by at least 30%? Secondary research question: can lifestyle intervention improve fatigue as measured by FSS in MG by at least 30%?
The primary outcome measure is MG-ADL; the secondary outcome measures include general fatigue (fatigue severity scale and Chalder´s fatigue scale). Exploratory outcome measures include OURA-ring-based markers, including heart rate variability, temperature fluctuations, and sleep and activity parameters. These will be collected throughout the entire study period for 30 weeks.
Analysis of serum biomarkers miR-150-5p and miR-30e-5p and inflammatory proteins found upregulated in MG will be included. Clinical data at baseline: antibody status, electrophysiology, MG Composite Scale (MGC), and clinical data at follow-up visits (medications, MGC), etc., are extracted from the medical charts and the Swedish MG registry
Inclusion criteria:
- An MG diagnosis for at least six months before entry into the study.
- Both patients with ocular and generalized MG are allowed to participate.
- For practical reasons, participants need to understand 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 a moderate-intensity physical activity of 150min or more per week, i.e., one of the target interventions.
- Pregnancy.
Each participant is enrolled in the study for 7 months, and 26 persons are randomized to one of the following 3 groups:
- Group 1; no intervention, observation with the OURA ring.
- Group 2: 12 weeks of physical activity guidance with short discussions via digital meetings regularly. They will conduct at least 150 minutes per week of moderate-intensity exercises. 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.
- Group 3: 12 weeks of sleep exercises. The lifestyle intervention of sleep will be delivered via an online group, with recommended home practices between sessions. Topics covered will include sleep education, sleep hygiene, and practices to improve sleep quality.
The study is digital and will use the platform "minforskning.se", which is validated according to GCP-GAMP5 and has the potential to collect digital consent forms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, randomized controlled trial, parallel-group design
| Arm | Type | Receives |
|---|---|---|
| Observation | No intervention | –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. |
| Physical activity | Experimental | Behavioral: Physical activity12 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. |
| Sleep hygiene intervention | Active comparator | Behavioral: Sleep hygiene12 weeks of sleep exercises. The lifestyle intervention of sleep will be delivered via an online group, with recommended home practices between sessions. Topics covered will include sleep education, sleep hygiene, and practices to improve sleep quality. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Physical activityIntervention with physical activity more than 150 minutes of medium to high intensity per week. | Behavioural | Physical activity |
| Sleep hygieneIntervention with sleep hygiene to optimize sleep duration and quality. | Behavioural | Sleep hygiene intervention |
Primary outcome
Myasthenia Gravis-Activities of Daily Living (MG-ADL)
Time frame: 7 months
Subjective assessment of MG-related fatiguability. A person's score can range from zero (normal) to 24 (most severe).
2 secondary outcomes
Fatigue Severity Scale (FSS)
Time frame: 7 months
Chalder Fatigue Scale
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 40675736Bhandage 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.
- Individual participant dataSharing planned: No. Not relevant.
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.
Anna Rostedt Punga, MD, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity and Sleep hygiene in people with Myasthenia Gravis, run by Uppsala University at 1 site in Sweden.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 30 Mar 2025. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Myasthenia Gravis-Activities of Daily Living (MG-ADL) (time frame: 7 months). 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 NCT05992025, which also lists 1 linked publication.
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 30 Mar 2025.