Myotonic Dystrophy Type 1 and Resistance Exercise (STYRK DM1)
Primary Purpose
Myotonic Dystrophy 1
Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Moderate-Heavy Resistance Exercise
Sponsored by
About this trial
This is an interventional other trial for Myotonic Dystrophy 1 focused on measuring Resistance exercise, Recovery, Muscle protein synthesis, Muscle protein breakdown, Muscle function
Eligibility Criteria
Inclusion Criteria:
- Confirmed Myotonic Dystrophy type 1-diagnosis
Exclusion Criteria:
- Non-ambulatory
- Injuries to muscle-skeletal-system that prevents resistance exercise
- Severe affection of the cardiovascular system
- Cognitive affection
- Lives more than one hour from test site
Sites / Locations
- Norwegian School of Sport Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
No Intervention
Experimental
No Intervention
Arm Label
DM1-Ex
DM1-Rest
Ctrl-Ex
Ctrl-Rest
Arm Description
Moderate-heavy resistance exercise of one leg in DM1-patients
Control leg (i.e. no exercise) in DM1-patients
Moderate-heavy resistance exercise of one leg in healthy participants
Control leg (i.e. no exercise) in healthy participants
Outcomes
Primary Outcome Measures
Change in muscle strength
Recovery of knee extension torque
Secondary Outcome Measures
Muscle protein synthesis rate
Rate of muscle protein synthesis in m. vastus lateralis between baseline and 27 hours after final session of resistance exercise
Muscle protein breakdown rate
Rate of muscle protein breakdown in m. vastus lateralis between baseline and 27 hours after final session of resistance exercise
Full Information
NCT ID
NCT05036447
First Posted
May 10, 2021
Last Updated
March 23, 2023
Sponsor
Norwegian School of Sport Sciences
Collaborators
Oslo University Hospital, University of Southern Denmark, University of Copenhagen, Maastricht University, University of Oslo
1. Study Identification
Unique Protocol Identification Number
NCT05036447
Brief Title
Myotonic Dystrophy Type 1 and Resistance Exercise
Acronym
STYRK DM1
Official Title
Recovery After Moderate-Heavy Resistance Exercise in Myotonic Dystrophy Type 1-patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 14, 2021 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Norwegian School of Sport Sciences
Collaborators
Oslo University Hospital, University of Southern Denmark, University of Copenhagen, Maastricht University, University of Oslo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the response after one bout of moderate-heavy resistance exercise in patients suffering from Myotonic Dystrophy type 1. There is still doubt about if these patients could benefit from resistance exercise, or if this mode of exercise is detrimental to their mobility and health. We aim to monitor the subjects during the recovery phase and investigate recovery in several ways.
Detailed Description
Myotonic dystrophy type 1 (DM1) is an autosomal, dominantly inherited, muscular disease and the most common muscular dystrophy amongst adults. The disease is characterized by progressive myopathy and myotonia, first evident in the distal parts of the body: calves and forearms, further progressing towards proximal parts. A recent review by Voet and co-workers (2013) concludes that exercise is safe for DM1-patients, and based on our current knowledge, DM1-patients should be able to gain positive adaptations from exercise. However, the physiological outcomes of an exercise stimulus are not well studied in this population and because of alterations in important Ca2+ handling systems the recovery processes might be significantly different from healthy muscles.
The aim of this study is to investigate the acute responses to moderate-heavy resistance exercise in DM1-patients. We aim to establish a timeline for recovery of muscle strength, measured as maximal voluntary contraction. In line with this, we want to investigate if any muscular damage has occurred with both direct and indirect measures, and possible mechanisms leading to muscle damage, i.e. impaired Ca2+ handling.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myotonic Dystrophy 1
Keywords
Resistance exercise, Recovery, Muscle protein synthesis, Muscle protein breakdown, Muscle function
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Participants in both groups (patients and control) perform unilateral leg resistance exercise, contralateral leg serves as control
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DM1-Ex
Arm Type
Experimental
Arm Description
Moderate-heavy resistance exercise of one leg in DM1-patients
Arm Title
DM1-Rest
Arm Type
No Intervention
Arm Description
Control leg (i.e. no exercise) in DM1-patients
Arm Title
Ctrl-Ex
Arm Type
Experimental
Arm Description
Moderate-heavy resistance exercise of one leg in healthy participants
Arm Title
Ctrl-Rest
Arm Type
No Intervention
Arm Description
Control leg (i.e. no exercise) in healthy participants
Intervention Type
Other
Intervention Name(s)
Moderate-Heavy Resistance Exercise
Intervention Description
Leg press: 3 x 8 repetitions at 75% of 1 repetition maximum, 3 minutes rest between sets.
Knee extension: 3 x 6 repetitions at 85% of 1 repetition maximum, 3 minutes rest between sets.
Primary Outcome Measure Information:
Title
Change in muscle strength
Description
Recovery of knee extension torque
Time Frame
Baseline, and 5 minutes, 3 hours, 24 hours, 48 hours, and 71 hours after exercise
Secondary Outcome Measure Information:
Title
Muscle protein synthesis rate
Description
Rate of muscle protein synthesis in m. vastus lateralis between baseline and 27 hours after final session of resistance exercise
Time Frame
Baseline and 27 hours after final session of resistance exercise
Title
Muscle protein breakdown rate
Description
Rate of muscle protein breakdown in m. vastus lateralis between baseline and 27 hours after final session of resistance exercise
Time Frame
Baseline and 27 hours after final session of resistance exercise
Other Pre-specified Outcome Measures:
Title
Change in muscle damage
Description
Myofibrillar disruption and necrosis observed in muscle tissue samples from m. vastus lateralis with electron microscopy
Time Frame
Baseline and 27 hours after final session of resistance exercise
Title
Change in muscle regeneration
Description
Appearance of macrophages, satellite cell localization, and disruption of membrane in single muscle fibers and cross-sections using confocal microscopy
Time Frame
Baseline and 27 hours after final session of resistance exercise
Title
Change in calcium cycling
Description
Calcium cycling in muscle tissue samples from m. vastus lateralis
Time Frame
Baseline and 27 hours after final session of resistance exercise
Title
Change in contractile function
Description
Assessment of contractile function in single muscle fibers from m. vastus lateralis
Time Frame
Baseline and 27 hours after final session of resistance exercise
Title
Change in calcium-related protein abundances
Description
Levels of protein and phosphorylation status using Western blotting
Time Frame
Baseline and 27 hours after final session of resistance exercise
Title
Muscle fiber type
Description
Fiber type composition in samples from m. vastus lateralis
Time Frame
Baseline
Title
Muscle fiber type
Description
Fiber type composition in samples from m. vastus lateralis
Time Frame
27 hours after final session of resistance exercise
Title
Change in heat shock proteins
Description
Localization and expression of heat shock proteins using Western blotting and Immunohistochemistry
Time Frame
Baseline and 27 hours after final session of resistance exercise
Title
Change in anabolic signaling
Description
Expression and phosphorylation status of central mediators in anabolic signaling pathways using Western blotting
Time Frame
Baseline and 27 hours after final session of resistance exercise
Title
Change in autophagy
Description
Expression and phosphorylation status of central mediators in pathways regulating muscle protein breakdown using Western blotting
Time Frame
Baseline and 27 hours after final session of resistance exercise
Title
Change in biomarkers of muscle damage
Description
Levels of serum Creatine kinase, Myoglobin, and Troponin I
Time Frame
Baseline, and 3 hours, 24 hours, 48 hours, 71 hours, and 96 hours after exercise
Title
Change in biomarker of muscle damage
Description
Level of titin-N fragment in urine
Time Frame
Baseline, and 20 hours, 44 hours, 68 hours, and 92 hours after exercise
Title
Change in Fatigue
Description
Electrical stimulation of m. vastus lateralis and m. vastus medialis at 10, 20, 50, and 80 Hz
Time Frame
Baseline, and 1 hour after exercise
Title
Change in muscle stiffness
Description
Muscle stiffness measured with shear wave elastography in static and dynamic conditions
Time Frame
Baseline, and 50 minutes after exercise
Title
Change in muscle soreness
Description
Subjective rating of muscle soreness using a visual analogue scale (0-10)
Time Frame
Baseline, and 3 hours, 24 hours, 48 hours, and 71 hours after exercise
Title
Change in muscle swelling
Description
Thickness of m. vastus lateralis using ultrasound B-mode
Time Frame
Baseline, and 3 hours, 24 hours, 48 hours, and 71 hours after exercise
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Confirmed Myotonic Dystrophy type 1-diagnosis
Exclusion Criteria:
Non-ambulatory
Injuries to muscle-skeletal-system that prevents resistance exercise
Severe affection of the cardiovascular system
Cognitive affection
Lives more than one hour from test site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Truls Raastad, PhD
Organizational Affiliation
Norwegian School of Sport Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norwegian School of Sport Sciences
City
Oslo
ZIP/Postal Code
0863
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
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Myotonic Dystrophy Type 1 and Resistance Exercise
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