Home-based Training and Supplementation in DM1 Patients (DM1HBET)
Myotonic Dystrophy 1
About this trial
This is an interventional supportive care trial for Myotonic Dystrophy 1 focused on measuring myotonic dystrophy, skeletal muscle, mitochondria
Eligibility Criteria
Age and sex-matched controls inclusion criteria: Healthy men and women Normal BMI (BMI 18.5 - 24.9 kg/m2) Inclusion Criteria for DM1 patients: Male or female clinically diagnosed with DM1 (age 19 - 60 y). CTG repeats 100-1000. Normal weight (BMI 18.5 - 24.9 kg/m2) or overweight (BMI 25 - 29.9 kg/m2). Physically inactive (< 1 hour of formal exercise/week). 6-minute walk test score between 250 - 500 meters ECG with PR interval < 225 ms and QRS duration < 125 ms. Exclusion Criteria for DM1 patients: Smoking Obese (BMI > 30.0 kg/m2) Physically active (> 1-2 hour of formal exercise/week) 6-minute walk test score <250 meters, chronic (> 2 weeks) Use of narcotic analgesic or anti-inflammatory drugs Type 1 or 2 diabetes (more than one anti-diabetic drug) Cardiovascular disease (recent myocardial infarction (< 6 months) Uncontrolled hypertension requiring more than 2 medications. Congestive heart failure requiring more than one medication for control. Cardiac conduction block (as above) Renal disease (creatinine > 140) Known liver disease Cognitive impairments limiting ability to provide informed consent Previous stroke with residual hemiparesis Active musculoskeletal injuries and/or severe osteoarthritis Significant weight loss in the 3-month period prior to the study Severe peripheral neuropathy Severe osteoporosis Use of medications known to affect protein metabolism (i.e. corticosteroids) Chronic obstructive or restrictive pulmonary disease (FVC < 70% of age predicted mean value) Asthma requiring more than two medications.
Sites / Locations
- McMaster University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Placebo Comparator
No Intervention
DM1 + HBEXT + MIS
DM1 + HBEXT + PLA
CONTROL
Participants will be asked to undergo 16 weeks of home-based training and asked to take one dose of a multi-ingredient supplement per day.
Participants will be asked to undergo 16 weeks of home-based training and asked to take one dose of a multi-ingredient supplement placebo per day.
Healthy control subjects who will not undergo study intervention and will be used for baseline measurements and outcomes.