Investigating Exercise in Myotonic Dystrophy Type 2 (DM2)

Conditions

• Myotonic Dystrophy 2

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Exercise — OTHER
  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 — OTHER
  Exercise virtually supervised by physical therapist and then self-directed for group B
• Exercise — OTHER
  Self-directed and virtually supervised exercise by physical therapist for Group C

Study Details

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.

Key Dates

Start date

Mar 4, 2025

Status verified

Apr 2026

Primary completion

Dec 1, 2027

Completion

Mar 1, 2028

Study Design

Enrollment

24 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

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

Primary Outcome Measure

Manual Muscle Test (MMT) [ Time Frame: From enrollment to the end of treatment at 6 months ]

Central Contacts

• Zoe Sheitman, DPT
  617-726-3642
  [email protected]

Locations (1)

Find similar trials in Boston, MA

Related Studies

• Myotonic Dystrophy Family Registry
  Recruiting · Myotonic Dystrophy Foundation · Oakland, California