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Completed

NCT Number: NCT05036447

Myotonic Dystrophy Type 1 and Resistance Exercise

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.

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Key information

Conditions

Myotonic Dystrophy 1 Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Musculoskeletal Diseases Myotonic Disorders Myotonic Dystrophy Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian School of Sport Sciences

Oslo, 0863, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moderate-Heavy Resistance Exercise

Other

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 outcomes

  1. Change in muscle strength

    Time frame: Baseline, and 5 minutes, 3 hours, 24 hours, 48 hours, and 71 hours after exercise

    Recovery of knee extension torque

Secondary outcomes

  1. Muscle protein synthesis rate

    Time frame: Baseline and 27 hours after final session of resistance exercise

    Rate of muscle protein synthesis in m. vastus lateralis between baseline and 27 hours after final session of resistance exercise

  2. Muscle protein breakdown rate

    Time frame: Baseline and 27 hours after final session of resistance exercise

    Rate of muscle protein breakdown in m. vastus lateralis between baseline and 27 hours after final session of resistance exercise

Other outcomes

  1. Change in muscle damage

    Time frame: Baseline and 27 hours after final session of resistance exercise

    Myofibrillar disruption and necrosis observed in muscle tissue samples from m. vastus lateralis with electron microscopy

  2. Change in muscle regeneration

    Time frame: Baseline and 27 hours after final session of resistance exercise

    Appearance of macrophages, satellite cell localization, and disruption of membrane in single muscle fibers and cross-sections using confocal microscopy

  3. Change in calcium cycling

    Time frame: Baseline and 27 hours after final session of resistance exercise

    Calcium cycling in muscle tissue samples from m. vastus lateralis

  4. Change in contractile function

    Time frame: Baseline and 27 hours after final session of resistance exercise

    Assessment of contractile function in single muscle fibers from m. vastus lateralis

  5. Change in calcium-related protein abundances

    Time frame: Baseline and 27 hours after final session of resistance exercise

    Levels of protein and phosphorylation status using Western blotting

  6. Muscle fiber type

    Time frame: Baseline

    Fiber type composition in samples from m. vastus lateralis

  7. Muscle fiber type

    Time frame: 27 hours after final session of resistance exercise

    Fiber type composition in samples from m. vastus lateralis

  8. Change in heat shock proteins

    Time frame: Baseline and 27 hours after final session of resistance exercise

    Localization and expression of heat shock proteins using Western blotting and Immunohistochemistry

  9. Change in anabolic signaling

    Time frame: Baseline and 27 hours after final session of resistance exercise

    Expression and phosphorylation status of central mediators in anabolic signaling pathways using Western blotting

  10. Change in autophagy

    Time frame: Baseline and 27 hours after final session of resistance exercise

    Expression and phosphorylation status of central mediators in pathways regulating muscle protein breakdown using Western blotting

  11. Change in biomarkers of muscle damage

    Time frame: Baseline, and 3 hours, 24 hours, 48 hours, 71 hours, and 96 hours after exercise

    Levels of serum Creatine kinase, Myoglobin, and Troponin I

  12. Change in biomarker of muscle damage

    Time frame: Baseline, and 20 hours, 44 hours, 68 hours, and 92 hours after exercise

    Level of titin-N fragment in urine

  13. Change in Fatigue

    Time frame: Baseline, and 1 hour after exercise

    Electrical stimulation of m. vastus lateralis and m. vastus medialis at 10, 20, 50, and 80 Hz

  14. Change in muscle stiffness

    Time frame: Baseline, and 50 minutes after exercise

    Muscle stiffness measured with shear wave elastography in static and dynamic conditions

  15. Change in muscle soreness

    Time frame: Baseline, and 3 hours, 24 hours, 48 hours, and 71 hours after exercise

    Subjective rating of muscle soreness using a visual analogue scale (0-10)

  16. Change in muscle swelling

    Time frame: Baseline, and 3 hours, 24 hours, 48 hours, and 71 hours after exercise

    Thickness of m. vastus lateralis using ultrasound B-mode

Sponsors and collaborators

Lead sponsor

Norwegian School of Sport Sciences

Other

Collaborators

  • Maastricht University
  • Oslo University Hospital
  • University of Copenhagen
  • University of Oslo
  • University of Southern Denmark

Registry information

Official study title

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

Acronym: STYRK DM1

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2021
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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