Exercise program for patients with myotonic dystrophy type 2
Investigating Benefits of A Physical Therapist (PT)-Guided Exercise Program in Myotonic Dystrophy Type 2 (DM2)
This study tests a new exercise program for people with myotonic dystrophy type 2 to see if it can help improve their strength and muscle health over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06716931 on ClinicalTrials.gov |
What this trial studies
This study investigates a specially designed exercise regimen called PRIME (Proximal Resistance In-House Movement Exercise) for patients with myotonic dystrophy type 2 (DM2). Participants will be randomized into three groups, with some exercising in-clinic under a physical therapist's supervision, others virtually, and a control group. The program aims to improve functional capacity and muscle composition over a six-month period, with the first three months supervised and the last three months performed independently at home. The study utilizes electrical impedance myography to assess muscle composition changes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with genetically confirmed myotonic dystrophy type 2 who are ambulatory and have a normal ECG.
Not a fit: Patients who are unable to participate in exercise due to severe cardiovascular issues or other significant health concerns may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance physical function and quality of life for patients with myotonic dystrophy type 2.
How similar studies have performed: While there is limited data on similar exercise interventions specifically for DM2, exercise programs have shown promise in improving outcomes in other neuromuscular disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Subjects younger than 18 years old or older than 70 years old. * 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 * Resting heart rate of \<60 or \>100 beats/minute at Screening visit. * Any fall within the last six months. * Any history of syncopal episodes or family history of sudden death. * 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.
Where this trial is running
Boston, Massachusetts
- Neuromuscular Diagnostic Center. Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Zoe Sheitman, DPT
- Email: zsheitman@mgh.harvard.edu
- Phone: 617-726-3642
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.