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New treatment option for Myotonic Dystrophy 2
Official title Investigating Exercise in Myotonic Dystrophy Type 2 (DM2)
ClinicalTrials.gov ID: NCT06716931
What this study is testing
- What it's testing
- 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.
- Time commitment: about 3 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Body mass index (BMI) ≥20 and ≤30.
You likely can't join if
- people younger than 18 years old or older than 70 years old.
- Inability or unwillingness of the subject to give written informed consent.
- people with pacemaker.
- Blood pressure \ 160 mmHg/90 mmHg at Screening visit
- Resting heart rate of \ 100 beats/minute at Screening visit.
- Any fall within the last six months.
See the full eligibility 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.
- people younger than 18 years old or older than 70 years old.
- Inability or unwillingness of the subject to give written informed consent.
- people with pacemaker.
- Blood pressure \ 160 mmHg/90 mmHg at Screening visit
- Resting heart rate of \ 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...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.