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Completed

NCT Number: NCT05400629

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

20 women with myotonic dystrophy type 1 (DM1) will complete a 12-week lower-limb strength training program. The training program consist 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 will be closely supervise and take place twice a week. It is hypothesize that the training program will induce muscular hypertrophy despite the genetic defect. The training program should also have positive effects on function. The participants will be evaluated at baseline, week 6, week 12, month 6 and month 9 to quantify the effects of the training program and if these effects will be 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

Female

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;
  • Women sex, 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 will be perform 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 3 and month 6

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

  4. Changes in maximal isometric muscle strength of the hip abductors

    Time frame: At baseline and week 12

    Changes in maximal isometric muscle strength of the hip abductors measure by quantify muscle testing using a handheld dynamometer

  5. 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 measure by quantify muscle testing using a handheld dynamometer

  6. Changes in maximal isometric grip strength

    Time frame: At baseline and week 12

    Changes in maximal isometric muscle strength of prehension measure by quantify muscle testing using a hand grip dynamometer

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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

  20. 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)

  21. 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)

  22. 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)

  23. 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

  24. 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)

  25. Changes in the time to perform of the Timed Up and Go

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

    Changes in the time to perform of the Timed Up and Go

  26. Changes in the time to perform the Timed stair test

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

    Changes in the time to perform the Timed stair test

  27. Change in the score of the Brief Pain Inventory

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

    Change in the score of the Brief Pain Inventory. The Brief Pain Inventory is a self-administer test that asses the dimensions of pain such as intensity of pain, functional incapacities, social and family repercussions, and psychological distress.

  28. Self-perceived changes in daily life

    Time frame: At week 12

    Self-perceived changes in daily life

  29. Change in the number of falls

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

    Number of falls in the last week and in the last month

  30. Change in score of the DM1-Activ questionnaire

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

    Change in score of the DM1-Activ questionnaire. This questionnaire asses activity and social participation with DM1 population. It contains 20 items with a maximal socre of 40 points, a lower score represent a bigger impact of the disease on activities and social participation.

  31. Change in blood : biochemical markers (CK, Protein C reactive, leukocytes, cytokines, etc.)

    Time frame: At baseline and week 12

    Change in blood : biochemical markers (CK, Protein C reactive, leukocytes, cytokines, etc.)

  32. Change in urine sample : exercise biomarkers (-Omics markers)

    Time frame: At baseline and week 12

    Change in urine sample : exercise biomarkers (-Omics markers)

  33. Change in saliva sample : exercise biomarkers (-Omics markers)

    Time frame: At baseline and week 12

    Change in saliva sample : exercise biomarkers (-Omics markers)

  34. Change of the center of pressure (COP) measure in static posturography : open eyes bipodal position

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

    Change of the center of pressure (COP) in static posturography : open eyes bipodal position

  35. Change of the center of pressure (COP) measure in static posturography : closed eyes bipodal position

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

    Change of the center of pressure (COP) in static posturography : closed eyes bipodal position

  36. Change of the center of pressure (COP) measure in static posturography : open eyes semi-tandem position

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

    Change of the center of pressure (COP) in static posturography : open eyes semi-tandem position

  37. Change of the center of pressure (COP) measure in static posturography : open eyes tandem position

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

    Change of the center of pressure (COP) in static posturography : open eyes tandem position

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Rare Disease Foundation

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jun 1, 2022
Registry last updated
Feb 10, 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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