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Digital Phenotyping and Lifestyle Intervention in Patients With Myasthenia Gravis (DIG-MG)

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ClinicalTrials.gov Identifier: NCT05992025
Recruitment Status : Recruiting
First Posted : August 15, 2023
Last Update Posted : August 15, 2023
Sponsor:
Information provided by (Responsible Party):
Uppsala University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Myasthenia Gravis Behavioral: Physical activity Behavioral: Sleep hygiene Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized controlled trial, parallel-group design
Masking: Single (Outcomes Assessor)
Masking Description: The statistician responsible for the outcome analysis will be blinded as to what intervention each group has had.
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial: Digital Phenotyping and Lifestyle Intervention in Patients With Myasthenia Gravis to Reduce Fatigue
Actual Study Start Date : July 10, 2023
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: 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.
Experimental: 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.
 Behavioral: Physical activity
Intervention with physical activity more than 150 minutes of medium to high intensity per week.
Active Comparator: 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.
 Behavioral: Sleep hygiene
Intervention with sleep hygiene to optimize sleep duration and quality.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Fatigue Severity Scale (FSS) [ Time Frame: 7 months ]
    The Fatigue Severity Scale (FSS) ranges from 0 (least fatigue) to 63 (maximum fatigue).

  2. Chalder Fatigue Scale [ Time Frame: 7 months ]
    The Chalder Fatigue Scale ranges from 0 (least fatigue) to 33 (maximum fatigue)


Other Outcome Measures:
  1. Heart rate variability [ Time Frame: 7 months ]
    Heart rate variability is measured with the OURA ring.

  2. Activity pattern [ Time Frame: 7 months ]
    Number of steps and minutes in moderate and high intensity activity is measured by the OURA ring.

  3. Percentage of deep sleep [ Time Frame: 7 months ]
    The OURA ring measures the sleep stages, including time and percentage for deep sleep every night.

  4. Circulating miRNA in serum [ Time Frame: 7 months ]
    Changes in miR-150-5p and miR-30e-5p in serum samples.

  5. Olink Target 96 Inflammation panel of cytokines [ Time Frame: 7 months ]
    Changes in cytokine NPX protein values (log2 scaled) using Proximity Extension Assay (PEA) technology in serum samples


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05992025


Contacts
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Contact: Anna Rostedt Punga, MD, PhD +46-18-4714941 anna.rostedt.punga@uu.se
Contact: Maja Norling, BSc +46-18-6110000 maja.norling@akademiska.se

Locations
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Sweden
Uppsala University Recruiting
Uppsala, Sweden, 75185
Contact: Anna Rostedt Punga, MD, PhD         
Sponsors and Collaborators
Uppsala University
Investigators
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Principal Investigator: Anna Rostedt Punga, MD, PhD Uppsala University
More Information
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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT05992025    
Other Study ID Numbers: 2023-01455-01
First Posted: August 15, 2023    Key Record Dates
Last Update Posted: August 15, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not relevant.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Uppsala University:
lifestyle intervention
fatigue
OURA
physical activity
Additional relevant MeSH terms:
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Myasthenia Gravis
Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
 Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Autoimmune Diseases of the Nervous System
Neurodegenerative Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases