Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06716931

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

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Neuromuscular Diagnostic Center. Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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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

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Investigating Exercise in Myotonic Dystrophy Type 2 (DM2) | DecenTrialz