Exercise for Myotonic Dystrophy
(DM2 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment PRIME: Proximal Resistance In-House Movement Exercise for myotonic dystrophy?
Is the PRIME Exercise Regimen safe for humans?
Resistance training, which includes exercises like the PRIME Exercise Regimen, is generally safe for humans when properly supervised and applied. However, there are concerns about adverse events (unwanted side effects) in people with chronic health conditions, so it's important to have trained supervision and consider individual health conditions when participating.678910
How does the PRIME Exercise Regimen differ from other treatments for myotonic dystrophy?
The PRIME Exercise Regimen is unique because it focuses on proximal resistance exercises that can be done at home, potentially making it more accessible and convenient for patients compared to other treatments that may require specialized equipment or settings. This approach emphasizes strengthening muscles close to the body's core, which may help improve muscle function and reduce symptoms of myotonic dystrophy.3451112
What is the purpose of this trial?
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 in clinic 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 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.
Eligibility Criteria
This trial is for individuals with Myotonic Dystrophy Type 2 (DM2). Participants should be willing to follow an exercise program and have their muscle strength, motor function, and muscle composition evaluated. The study excludes details on specific inclusion or exclusion criteria.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants engage in a PT-guided exercise program with different modalities based on group assignment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- PRIME: Proximal Resistance In-House Movement Exercise
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor