Digital Phenotyping and Lifestyle Intervention in Patients with Myasthenia Gravis

NCT ID: NCT05992025

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-10
• Study Completion Date: 2025-03-15

Brief 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. 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.

Conditions

Myasthenia Gravis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Observation

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Physical activity

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.

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: BEHAVIORAL

Intervention with physical activity more than 150 minutes of medium to high intensity per week.

Sleep hygiene intervention

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.

Group Type: ACTIVE_COMPARATOR

Sleep hygiene

Intervention Type: BEHAVIORAL

Intervention with sleep hygiene to optimize sleep duration and quality.

Interventions

Physical activity

Intervention with physical activity more than 150 minutes of medium to high intensity per week.

Intervention Type: BEHAVIORAL

Sleep hygiene

Intervention with sleep hygiene to optimize sleep duration and quality.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Rostedt Punga, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

Uppsala University

Uppsala, , Sweden

Countries

Sweden

Other Identifiers

2023-01455-01

Identifier Type: -

Identifier Source: org_study_id