Myotonic Dystrophy Type 1 and Resistance Exercise

Myotonic Dystrophy 1 Clinical Trial

— STYRK DM1  

Official title:

Recovery After Moderate-Heavy Resistance Exercise in Myotonic Dystrophy Type 1-patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05036447
• Other study ID #: STYRK DM1
• Status: Completed
• Phase: N/A
• Start date: June 14, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: November 2023
• Source: Norwegian School of Sport Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Myotonic Dystrophy
• Myotonic Dystrophy 1

Intervention

Other:
• Moderate-Heavy Resistance Exercise
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.

Locations

Country	Name	City	State
Norway	Norwegian School of Sport Sciences	Oslo

Sponsors (6)

Lead Sponsor	Collaborator
Norwegian School of Sport Sciences	Maastricht University, Oslo University Hospital, University of Copenhagen, University of Oslo, University of Southern Denmark

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in muscle damage	Myofibrillar disruption and necrosis observed in muscle tissue samples from m. vastus lateralis with electron microscopy	Baseline and 27 hours after final session of resistance exercise
Other	Change in muscle regeneration	Appearance of macrophages, satellite cell localization, and disruption of membrane in single muscle fibers and cross-sections using confocal microscopy	Baseline and 27 hours after final session of resistance exercise
Other	Change in calcium cycling	Calcium cycling in muscle tissue samples from m. vastus lateralis	Baseline and 27 hours after final session of resistance exercise
Other	Change in contractile function	Assessment of contractile function in single muscle fibers from m. vastus lateralis	Baseline and 27 hours after final session of resistance exercise
Other	Change in calcium-related protein abundances	Levels of protein and phosphorylation status using Western blotting	Baseline and 27 hours after final session of resistance exercise
Other	Muscle fiber type	Fiber type composition in samples from m. vastus lateralis	Baseline
Other	Muscle fiber type	Fiber type composition in samples from m. vastus lateralis	27 hours after final session of resistance exercise
Other	Change in heat shock proteins	Localization and expression of heat shock proteins using Western blotting and Immunohistochemistry	Baseline and 27 hours after final session of resistance exercise
Other	Change in anabolic signaling	Expression and phosphorylation status of central mediators in anabolic signaling pathways using Western blotting	Baseline and 27 hours after final session of resistance exercise
Other	Change in autophagy	Expression and phosphorylation status of central mediators in pathways regulating muscle protein breakdown using Western blotting	Baseline and 27 hours after final session of resistance exercise
Other	Change in biomarkers of muscle damage	Levels of serum Creatine kinase, Myoglobin, and Troponin I	Baseline, and 3 hours, 24 hours, 48 hours, 71 hours, and 96 hours after exercise
Other	Change in biomarker of muscle damage	Level of titin-N fragment in urine	Baseline, and 20 hours, 44 hours, 68 hours, and 92 hours after exercise
Other	Change in Fatigue	Electrical stimulation of m. vastus lateralis and m. vastus medialis at 10, 20, 50, and 80 Hz	Baseline, and 1 hour after exercise
Other	Change in muscle stiffness	Muscle stiffness measured with shear wave elastography in static and dynamic conditions	Baseline, and 50 minutes after exercise
Other	Change in muscle soreness	Subjective rating of muscle soreness using a visual analogue scale (0-10)	Baseline, and 3 hours, 24 hours, 48 hours, and 71 hours after exercise
Other	Change in muscle swelling	Thickness of m. vastus lateralis using ultrasound B-mode	Baseline, and 3 hours, 24 hours, 48 hours, and 71 hours after exercise
Primary	Change in muscle strength	Recovery of knee extension torque	Baseline, and 5 minutes, 3 hours, 24 hours, 48 hours, and 71 hours after exercise
Secondary	Muscle protein synthesis rate	Rate of muscle protein synthesis in m. vastus lateralis between baseline and 27 hours after final session of resistance exercise	Baseline and 27 hours after final session of resistance exercise
Secondary	Muscle protein breakdown rate	Rate of muscle protein breakdown in m. vastus lateralis between baseline and 27 hours after final session of resistance exercise	Baseline and 27 hours after final session of resistance exercise