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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Exercise under the supervision of physical therapist in clinic during the first 3 months, then self-directed exercise routine for the last 3 months |
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| Group B | Active Comparator | Exercise under the supervision of physical therapist virtually during the first 3 months, then self-directed exercise routine for the last 3 months |
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| Group C | Active Comparator | Self-directed exercise routine for the first 3 months, then exercise routine under the supervision of physical therapist virtually during the last 3 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Manual Muscle Test (MMT) | Score of manual muscle strength test scale. This is a strength exam at bedside of muscle groups | From enrollment to the end of treatment at 6 months |
| Six-minute walking test | Distance in meters that subject can walk in six minutes | From enrollment to the end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative myometry | Muscle dynamometry of different muscle groups measured in kilograms | From enrollment to the end of treatment at 6 months |
| Muscle resistance/reactance measures in ohms | using electrical impedance myography, resistance and reactance measures in ohms will be obtained simultaneously from each examined muscle |
| Measure | Description | Time Frame |
|---|---|---|
| Time up to go | Time in seconds from standing up, walk 3 meters, come back and sit again. | From enrollment to the end of treatment at 6 months |
| 10 meter walk testing | Time in seconds during a 10-meter walk. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zoe Sheitman, DPT | Contact | 617-726-3642 | zsheitman@mgh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuromuscular Diagnostic Center. Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D009223 | Myotonic Dystrophy |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009136 | Muscular Dystrophies |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Exercise | Other | Exercise virtually supervised by physical therapist and then self-directed for group B |
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| Exercise | Other | Self-directed and virtually supervised exercise by physical therapist for Group C |
|
| From enrollment to the end of treatment at 6 months |
| From enrollment to the end of treatment at 6 months |
| Five times sit to stand | Time in seconds to complete 5 times sit to stand. | From enrollment to the end of treatment at 6 months |
| Functional gait assessment (FGA) | Assessment of balance using a scale (0-30) while walking and performing motor tasks. | From enrollment to the end of treatment at 6 months |
| D020967 | Myotonic Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001519 | Behavior |