Investigating Exercise in Myotonic Dystrophy Type 2 (DM2)
Key facts
- Who runs it
- Massachusetts General Hospital
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 24 people, planned
- Started
- 4 Mar 2025
- Expected to end
- 1 Mar 2028
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Exercise
- Record updated
- 8 October 2026
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Patients with genetically confirmed myotonic dystrophy 2 (DM2) who are ≥18 and ≤ 70 years old
- Patients are ambulatory without need of any assistance or device
- Patients have a normal ECG within the 3 months prior to Screening visit (of note, patients with DM2 are recommended to have routine ECG as part of patient care. So, this ECG will be done as part of patient care)
- Body mass index (BMI) ≥20 and ≤30
Who cannot take part
- Resting heart rate of <60 or >100 beats/minute at Screening visit
- Any history of syncopal episodes or family history of sudden death
- Subjects younger than 18 years old or older than 70 years old
- Patients who are pregnant or plan to become pregnant. A urine pregnancy test will be performed at visit 1 and 3 for women of childbearing age. If positive or if subject is planning to become pregnant, subject will be not eligible for the study
- Inability or unwillingness of the subject to give written informed consent
- Subjects with pacemaker
- Blood pressure <90/50 mmHg or >160 mmHg/90 mmHg at Screening visit
- Any fall within the last six months
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Where in United States
- Neuromuscular Diagnostic Center - Massachusetts General HospitalBoston, United StatesContact: Blanca Escauriaza, RNTaking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Group AExisting treatment, for comparison
Exercise under the supervision of physical therapist in clinic during the first 3 months, then self-directed exercise routine for the last 3 months
Treatment: Exercise
- Group BExisting treatment, for comparison
Exercise under the supervision of physical therapist virtually during the first 3 months, then self-directed exercise routine for the last 3 months
Treatment: Exercise
- Group CExisting treatment, for comparison
Self-directed exercise routine for the first 3 months, then exercise routine under the supervision of physical therapist virtually during the last 3 months
Treatment: Exercise
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Investigating Benefits of A Physical Therapist (PT)-Guided Exercise Program in Myotonic Dystrophy Type 2 (DM2)
- Fit questions
- Built from NCT06716931, who can take part
- Record updated
- 8 October 2026