Exercise program for patients with myotonic dystrophy type 2

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Neuromuscular Diagnostic Center. Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Blanca Escauriaza, RN
• Email: bescauriaza@mgh.harvard.edu
• Phone: 617-726-3642

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Online registry for myotonic dystrophy patients

  This study is creating an online registry for people with myotonic dystrophy to share their experiences and help researchers find better treatments.

  Recruiting Myotonic Dystrophy Foundation · Oakland, California · NCT02398786

• Metabolomic biomarkers for myotonic dystrophy

  This study tests whether urine and blood tests, along with muscle function tests, can detect and measure myotonic dystrophy activity and severity without relying on muscle biopsies.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT07912983

• Two group-based, telehealth caregiver programs to reduce stress in dementia caregivers

  This trial tests whether Caring Together or Savvy Caregiver, delivered by telehealth, best reduces caregiver stress for people caring for someone with memory loss.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT07868588

• Heart Rate Variability Biofeedback for Anxiety in Autistic Youth

  This study tests a wearable heart rate variability biofeedback tool to see if it helps reduce anxiety in autistic teens.

  Recruiting Phase 2 Massachusetts General Hospital · Lexington, Massachusetts · NCT07812233

• Brillouin hydration mapping to study cornea health

  Researchers test a Brillouin microscope to see if it can measure corneal water content in healthy people and those with eye conditions.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT07780890

• Identifying Signatures of Gut Interoception in Functional Dyspepsia and Anorexia Nervosa

  This study tests how the gut-brain connection works in people with functional dyspepsia or anorexia nervosa using brain imaging.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT07772167

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.