Neuromuscular Diagnostic Center. Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Location status: Recruiting
NCT Number: NCT06716931
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: From enrollment to the end of treatment at 6 months
Score of manual muscle strength test scale. This is a strength exam at bedside of muscle groups
Time frame: From enrollment to the end of treatment at 6 months
Distance in meters that subject can walk in six minutes
Time frame: From enrollment to the end of treatment at 6 months
Muscle dynamometry of different muscle groups measured in kilograms
Time frame: From enrollment to the end of treatment at 6 months
using electrical impedance myography, resistance and reactance measures in ohms will be obtained simultaneously from each examined muscle
Time frame: From enrollment to the end of treatment at 6 months
Time in seconds from standing up, walk 3 meters, come back and sit again.
Time frame: From enrollment to the end of treatment at 6 months
Time in seconds during a 10-meter walk.
Time frame: From enrollment to the end of treatment at 6 months
Time in seconds to complete 5 times sit to stand.
Time frame: From enrollment to the end of treatment at 6 months
Assessment of balance using a scale (0-30) while walking and performing motor tasks.
Contact information is provided by the study sponsor or research team.
Massachusetts General Hospital
Other
Investigating Benefits of A Physical Therapist (PT)-Guided Exercise Program in Myotonic Dystrophy Type 2 (DM2)
Acronym: DM2
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