RECRUITING

Investigating Exercise in Myotonic Dystrophy Type 2 (DM2)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Investigating Benefits of a Physical Therapist (PT)-Guided Exercise Program in Myotonic Dystrophy Type 2 (DM2)

Quick Facts

Study Start:2024-12-01
Study Completion:2026-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06716931

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with genetically confirmed myotonic dystrophy 2 (DM2) who are ≥18 and ≤ 70 years old.
  2. * Patients are ambulatory without need of any assistance or device.
  3. * 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).
  4. * Body mass index (BMI) ≥20 and ≤30.
  1. * Subjects younger than 18 years old or older than 70 years old.
  2. * Inability or unwillingness of the subject to give written informed consent.
  3. * Subjects with pacemaker.
  4. * Blood pressure \<90/50 mmHg or \>160 mmHg/90 mmHg at Screening visit
  5. * Resting heart rate of \<60 or \>100 beats/minute at Screening visit.
  6. * Any fall within the last six months.
  7. * Any history of syncopal episodes or family history of sudden death.
  8. * 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.

Contacts and Locations

Study Contact

Zoe Sheitman, DPT
CONTACT
617-726-3642
zsheitman@mgh.harvard.edu

Study Locations (Sites)

Neuromuscular Diagnostic Center. Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-01
Study Completion Date2026-03-01

Study Record Updates

Study Start Date2024-12-01
Study Completion Date2026-03-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Myotonic Dystrophy 2