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Completed

NCT Number: NCT04018820

Effects of a 12-week Strength Training Program in Men With Myotonic Dystrophy Type 1

Eleven men with myotonic dystrophy type 1 (DM1) underwent a 12-week lower-limb strength training program. The training program consisted of 3 series of 6 to 8 maximal repetitions of 5 different exercises: Leg extension, leg press, hip abduction, squat and plantar flexion. Training sessions were closely supervised and took place twice a week. It is hypothesised that the training program will induce muscular hypertrophy despite the genetic defect. The training program should also have positive effects on function. The participants were evaluated at baseline, week 6, week 12, month 6 and month 9 to see the effects of the training program and if these effects are maintained over time.

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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

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Groupe de recherche interdisciplinaire sur les maladies neuromusculaires

Saguenay, Quebec, G7X 7X2, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • DM1 diagnosis must be confirmed by genetic analysis;
  • Male gender, aged between 30 and 65 years old;
  • Be able to walk without assistance;
  • Consent of the neurologist must be given to participate in this study;
  • Must reside in the Saguenay-Lac-St-Jean region;
  • Subjects must be able to give their consent freely and voluntarily.

Exclusion criteria

  • Patients with any other form of muscular dystrophy are excluded;
  • Any contraindication for strenuous exercise or muscle biopsy.

Treatment and study plan

Training program

Other

12-week strength training program of the lower limbs consisting of 5 different exercises: Leg extension, leg press, hip abduction, squat and plantar flexion. All exercises were performed between 6 and 8 maximal repetitions.

Primary outcomes

  1. Changes in maximal isometric muscle strength of the knee extensors

    Time frame: At baseline, week 6, week 12, month 6 and month 9

    Changes in maximal isometric muscle strength of the knee extensors measured by quantified muscle testing using a handheld dynamometer

Secondary outcomes

  1. Changes in maximal isometric muscle strength of the knee flexors

    Time frame: At baseline and week 12

    Changes in maximal isometric muscle strength of the knee flexors measured by quantified muscle testing using a handheld dynamometer

  2. Changes in maximal isometric muscle strength of the hip flexors

    Time frame: At baseline and week 12

    Changes in maximal isometric muscle strength of the hip flexors measured by quantified muscle testing using a handheld dynamometer

  3. Changes in maximal isometric muscle strength of the hip extensors

    Time frame: At baseline and week 12

    Changes in maximal isometric muscle strength of the hip extensors measured by quantified muscle testing using a handheld dynamometer

  4. Changes in maximal isometric muscle strength of the ankle dorsiflexors

    Time frame: At baseline and week 12

    Changes in maximal isometric muscle strength of the ankle dorsiflexors measured by quantified muscle testing using a handheld dynamometer

  5. Changes in 1-repetition maximum strength of the leg extension exercise

    Time frame: At baseline, week 6 and week 12

    Changes in 1-repetition maximum strength of the leg extension exercise

  6. Changes in 1-repetition maximum strength of the leg press exercise

    Time frame: At baseline, week 6 and week 12

    Changes in 1-repetition maximum strength of the leg press exercise

  7. Changes in 1-repetition maximum strength of the hip abduction exercise

    Time frame: At baseline, week 6 and week 12

    Changes in 1-repetition maximum strength of the hip abduction exercise

  8. Changes in 1-repetition maximum strength of the squat exercise

    Time frame: At baseline, week 6 and week 12

    Changes in 1-repetition maximum strength of the squat exercise

  9. Changes in comfortable walking speed in the 10-meter walk test

    Time frame: At baseline, week 6, week 12, month 6 and month 9

    Changes in comfortable walking speed in the 10-meter walk test

  10. Changes in maximal walking speed in the 10-meter walk test

    Time frame: At baseline, week 6, week 12, month 6 and month 9

    Changes in maximal walking speed in the 10-meter walk test

  11. Changes in the number of repetitions in the 30-seconds sit-to-stand test

    Time frame: At baseline, week 6, week 12, month 6 and month 9

    Changes in the number of repetitions in the 30-seconds sit-to-stand test

  12. Changes in the score of the lower extremity functional scale

    Time frame: At baseline, week 12, month 6 and month 9

    Changes in the score of the lower extremity functional scale (LEFS). The LEFS is an 80-point questionnaire with 20 items scored from 0 to 4. A score of 80 means no disfunction while a score of 0 means maximal disfunction.

  13. Changes in the score of the myotonic dystrophy health index

    Time frame: At baseline, week 6, week 12, month 6 and month 9

    Changes in the score of the myotonic dystrophy health index (MDHI). The MDHI is a 114-item questionnaire scored from 0 to 100, where 0 means no disability and 100 means maximal disability.

  14. Changes in the score of the Fatigue and Daytime Sleepiness Scale

    Time frame: At baseline, week 6, week 12, month 6 and month 9

    Changes in the score of the Fatigue and Daytime Sleepiness Scale (FDSS). The FDSS is a 12-item questionnaire where all questions are scored from 0 to 2. A higher score means more daytime sleepiness and fatigue.

  15. Changes in the Marin apathy scale

    Time frame: At baseline, week 12, month 6 and month 9

    Changes in the Marin apathy scale. The Marin apathy scale is scored by the clinician where he interviews the subject and then scores an 18-item list on a scale of 1 to 4. A high score means more apathy.

  16. Changes in the Well-Being Manifestations Measure Scale

    Time frame: At baseline, week 6, week 12 and month 6

    Changes in the Well-Being Manifestations Measure Scale (WBMMS). The WBMMS is a 25-item questionnaire where each question is scored on a scale from 1 to 5. A high score means high well-being.

  17. Changes in the Hospital Anxiety and Depression Scale

    Time frame: At baseline, week 6, week 12 and month 6

    Changes in the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item questionnaire with a scale from 0 to 3 for each item. A high score means high depression and anxiety.

  18. Changes in muscle biopsy of the vastus lateralis: muscle fiber typing

    Time frame: At baseline and week 12

    Changes in muscle biopsy of the vastus lateralis: muscle fiber typing

  19. Changes in muscle biopsy of the vastus lateralis: muscle fiber size

    Time frame: At baseline and week 12

    Changes in muscle biopsy of the vastus lateralis: muscle fiber size (smallest diameter of the fiber)

  20. Changes in muscle biopsy of the vastus lateralis: muscle proteomics

    Time frame: At baseline and week 12

    Changes in muscle biopsy of the vastus lateralis: muscle proteomics (protein expression)

  21. Changes in muscle biopsy of the vastus lateralis: muscle transcriptomics

    Time frame: At baseline and week 12

    Changes in muscle biopsy of the vastus lateralis: muscle transcriptomics (RNA expression analysis)

  22. Changes in muscle biopsy of the vastus lateralis: mitochondrial function

    Time frame: At baseline and week 12

    Changes in muscle biopsy of the vastus lateralis: mitochondrial function. Analysis of mitochondrial markers and enzymes

  23. Changes in muscle biopsy of the vastus lateralis: Nuclear foci

    Time frame: At baseline and week 12

    Changes in muscle biopsy of the vastus lateralis: Nuclear foci (changes in accumulation of nuclear foci)

Sponsors and collaborators

Lead sponsor

Élise Duchesne

Other

Collaborators

  • Fondation du Grand défi Pierre Lavoie

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 15, 2019
Registry last updated
Dec 15, 2021

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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