Actively Recruiting
Investigating Exercise in Myotonic Dystrophy Type 2 (DM2)
Led by Massachusetts General Hospital · Updated on 2026-04-15
24
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An exercise regimen (PRIME: Proximal Resistance In-House Movement Exercise) has been designed for patients with myotonic dystrophy type 2 (DM2). The hypothesis is that this patient-friendly physical therapist (PT)-guided exercise program associates with improved functional capacity and muscle composition in DM2 in this two-period two-sequence cross-over study. Thus, participant will be randomized to one of the three possible groups. Participants in GROUP A will perform exercise routine virtually under the direct supervision of a physical therapist once a week and another session on their own for the first three months, then they will continue with same exercise routine at home for the last 3 months on their own. Participants in GROUP B will perform exercise routine virtually under the direct supervision of a physical therapist twice a week for the first three months, then they will continue with same exercise routine at home for the last 3 months on their own. Participants in GROUP C will perform exercise routine on their own during the first 3 months, then they will perform exercise routine virtually under the direct supervision of a physical therapist. Each group will include around 8 participants. Duration of the study is 6 months. In addition to exercise sessions, participants will have evaluation of their strength, motor function and muscle composition at three time points: initiation, 3 months and completion of the study at 6 months. Muscle composition will be assessed by electrical impedance myography which is a portable, non-invasive, painless and non-radiation tool that applies a weak high multifrequency electrical current to the examined muscle and allows to obtain information about its composition.
CONDITIONS
Official Title
Investigating Exercise in Myotonic Dystrophy Type 2 (DM2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with genetically confirmed myotonic dystrophy 2 (DM2) aged 18 to 70 years
- Ability to walk without any assistance or device
- Normal ECG within 3 months before screening
- Body mass index (BMI) between 20 and 30
You will not qualify if you...
- Younger than 18 years or older than 70 years
- Unable or unwilling to provide written informed consent
- Presence of a pacemaker
- Blood pressure below 90/50 mmHg or above 160/90 mmHg at screening
- Resting heart rate below 60 or above 100 beats per minute at screening
- Any fall in the last six months
- History of fainting episodes or family history of sudden death
- Pregnant or planning to become pregnant (pregnancy test performed at visits 1 and 3)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Neuromuscular Diagnostic Center. Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
Z
Zoe Sheitman, DPT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here