Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05992025 |
| Other study ID # |
2023-01455-01 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 10, 2023 |
| Est. completion date |
July 2025 |
Study information
| Verified date |
August 2023 |
| Source |
Uppsala University |
| Contact |
Anna Rostedt Punga, MD, PhD |
| Phone |
+46-18-4714941 |
| Email |
anna.rostedt.punga[@]uu.se |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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).
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.
