Digital Phenotyping and Lifestyle Intervention in Patients with Myasthenia Gravis

NCT05992025 | Completed

• 1 other identifier: 2023-01455-01
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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).

Conditions

Myasthenia Gravis

Keywords

lifestyle intervention; fatigue; OURA; physical activity

Outcome Measures

Primary Outcomes (1)

• 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).

  7 months

Secondary Outcomes (2)

• Fatigue Severity Scale (FSS)

  7 months

• Chalder Fatigue Scale

  7 months

Other Outcomes (5)

• Heart rate variability

  7 months

• Activity pattern

  7 months

• Percentage of deep sleep

  7 months

Study Arms (3)

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.

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.

Behavioral: Sleep hygiene

Interventions

Physical activity BEHAVIORAL

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

Physical activity

Sleep hygiene BEHAVIORAL

Intervention with sleep hygiene to optimize sleep duration and quality.

Sleep hygiene intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Uppsala University

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Myasthenia Gravis; Fatigue; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anna Rostedt Punga, MD, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician responsible for the outcome analysis will be blinded as to what intervention each group has had.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized controlled trial, parallel-group design

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: August 15, 2023
• Study Start: July 10, 2023
• Primary Completion: August 15, 2024
• Study Completion: March 15, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)