Recruiting

Exercise

Sponsor:

Massachusetts General Hospital

Code:

NCT06716931

Conditions

Myotonic Dystrophy 2

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Exercise

Exercise

Exercise

Study Details

Brief summary:

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

Myotonic Dystrophy 2

Study ID

NCT06716931

Start date

Mar 4, 2025

Status verified date

Apr, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group A

Exercise under the supervision of physical therapist in clinic during the first 3 months, then self-directed exercise routine for the last 3 months

active comparator: Group B

Exercise under the supervision of physical therapist virtually during the first 3 months, then self-directed exercise routine for the last 3 months

active comparator: Group C

Self-directed exercise routine for the first 3 months, then exercise routine under the supervision of physical therapist virtually during the last 3 months

Interventions

Exercise

A patient-friendly exercise routine has been designed for patients with myotonic dystrophy type 2. Benefits of this exercise regimen in different settings (at home versus clinic, self-directed versus physical therapist-directed) will be investigated.

In person exercise supervised by physical therapist and then self-directed exercise in Group A

Exercise

Exercise virtually supervised by physical therapist and then self-directed for group B

Exercise

Self-directed and virtually supervised exercise by physical therapist for Group C

Primary outcome measure

  • Manual Muscle Test (MMT) [ Time Frame: From enrollment to the end of treatment at 6 months ]
  • Six-minute walking test [ Time Frame: From enrollment to the end of treatment at 6 months ]

Central Contacts and Locations

Central contacts

Zoe Sheitman, DPT

617-726-3642zsheitman@mgh.harvard.edu

Locations

Neuromuscular Diagnostic Center. Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Zoe Sheitman, DPT

617-724-5297zsheitman@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

  • exercise
  • physical therapist
  • myotonic dystrophy type 2
  • electrical impedance myography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-04-15.