24 Participants Needed

Exercise for Myotonic Dystrophy

(DM2 Trial)

ZS
Overseen ByZoe Sheitman, DPT
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Research shows that high-resistance training can improve muscle strength in patients with myotonic dystrophy without negative side effects, suggesting that similar exercise regimens like PRIME may also be beneficial.12345

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

I am between 18 and 70 years old with confirmed myotonic dystrophy 2.
Patients have a normal ECG within the 3 months prior to Screening visit
Body mass index (BMI) between 20 and 30
See 1 more

Exclusion Criteria

Subjects with pacemaker
Any history of syncopal episodes or family history of sudden death
Any fall within the last six months
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a PT-guided exercise program with different modalities based on group assignment

6 months
Bi-weekly visits (in-person or virtual) for the first 3 months, self-directed for the last 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • PRIME: Proximal Resistance In-House Movement Exercise
Trial Overview The PRIME exercise regimen for DM2 patients is being tested. It's a two-sequence cross-over study where participants are randomly assigned to one of three groups: in-clinic supervised exercise, virtual supervised exercise, or independent home-based exercise before switching modes after 3 months.
Participant Groups
3Treatment groups
Active Control
Group I: Group BActive Control1 Intervention
Exercise under the supervision of physical therapist virtually during the first 3 months, then self-directed exercise routine for the last 3 months
Group II: Group AActive Control1 Intervention
Exercise under the supervision of physical therapist in clinic during the first 3 months, then self-directed exercise routine for the last 3 months
Group III: Group CActive Control1 Intervention
Self-directed exercise routine for the first 3 months, then exercise routine under the supervision of physical therapist virtually during the last 3 months

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Findings from Research

A 46-year-old woman with myotonic dystrophy type 1 (DM1) showed significant improvements in walking, balance, and muscle strength after undergoing a combined rehabilitation approach that included both conventional physiotherapy and robotic training with the Ekso-GT exoskeleton.
This case study suggests that integrating robotic technologies into rehabilitation for DM1 can enhance therapeutic outcomes by effectively engaging neural networks, potentially leading to better motor and functional recovery.
Overground exoskeletons may boost neuroplasticity in myotonic dystrophy type 1 rehabilitation: A case report.Portaro, S., Naro, A., Leo, A., et al.[2023]
In a study involving 10 patients with myotonic dystrophy type 2 (DM2), a 16-week supervised exercise training program significantly improved functional capacity, including handgrip strength and walking distance.
The exercise training also led to increases in lean body mass and bone mineral density, while reducing arterial pressure, suggesting that exercise can be beneficial for DM2 patients despite the lack of medical treatments.
Effect of exercise training on functional capacity and body composition in myotonic dystrophy type 2 patients.Kontou, E., Papadopoulos, C., Papadimas, G., et al.[2021]
A 14-week exercise program, Friskis&Svettisยฎ Open Doors, was feasible and well-tolerated by 35 adults with myotonic dystrophy type 1, with no reported negative effects.
While the program did not show significant improvements in physical functioning or health-related quality of life, it did lead to a slight increase in mental health scores for the training group compared to controls.
Feasibility and effects of a physical exercise programme in adults with myotonic dystrophy type 1: a randomized controlled pilot study.Kierkegaard, M., Harms-Ringdahl, K., Edstrรถm, L., et al.[2015]

References

Overground exoskeletons may boost neuroplasticity in myotonic dystrophy type 1 rehabilitation: A case report. [2023]
Effect of exercise training on functional capacity and body composition in myotonic dystrophy type 2 patients. [2021]
Feasibility and effects of a physical exercise programme in adults with myotonic dystrophy type 1: a randomized controlled pilot study. [2015]
Effects of high resistance training in patients with myotonic dystrophy. [2008]
What is known about the effects of exercise or training to reduce skeletal muscle impairments of patients with myotonic dystrophy type 1? A scoping review. [2020]
Efficacy and Safety of Low Frequency Whole-Body Electromyostimulation (WB-EMS) to Improve Health-Related Outcomes in Non-athletic Adults. A Systematic Review. [2022]
Minimal-Dose Resistance Training for Improving Muscle Mass, Strength, and Function: A Narrative Review of Current Evidence and Practical Considerations. [2022]
Exploring participants' perspectives on adverse events due to resistance training: a qualitative study. [2023]
Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Adverse events reported in progressive resistance strength training trials in older adults: 2 sides of a coin. [2010]
Chronic exercise mitigates disease mechanisms and improves muscle function in myotonic dystrophy type 1 mice. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Antisense oligonucleotide and adjuvant exercise therapy reverse fatigue in old mice with myotonic dystrophy. [2021]
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