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Trial record 7 of 51 for:    Myotonic Dystrophy

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

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ClinicalTrials.gov Identifier: NCT04018820
Recruitment Status : Completed
First Posted : July 15, 2019
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
Fondation du Grand défi Pierre Lavoie
Information provided by (Responsible Party):
Élise Duchesne, Université de Sherbrooke

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myotonic Dystrophy 1 Other: Training program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Participants had to complete a 12-week strength training program and return to their normal activities for the following 6 months after the end of the training program
Masking: None (Open Label)
Masking Description: Most outcomes where not masked, however the outcome assessor was masked for all muscle biopsy analysis: while analysing the muscle biopsy outcomes, the outcome assessor did not know if it was from baseline or from after the training program.
Primary Purpose: Supportive Care
Official Title: Effects of a 12-week Strength Training Program in Men With Myotonic Dystrophy Type 1
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : June 22, 2018
Actual Study Completion Date : June 22, 2018


Arm Intervention/treatment
Experimental: Training program Other: Training program
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 Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018820


Locations
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Canada, Quebec
Groupe de recherche interdisciplinaire sur les maladies neuromusculaires
Saguenay, Quebec, Canada, G7X 7X2
Sponsors and Collaborators
Élise Duchesne
Fondation du Grand défi Pierre Lavoie
Investigators
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Principal Investigator: Elise Duchesne, Ph.D. Université du Québec à Chicoutimi

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Responsible Party: Élise Duchesne, Sponsor-Investigator, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT04018820     History of Changes
Other Study ID Numbers: 2017-005
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myotonic Dystrophy
Muscular Dystrophies
Myotonic Disorders
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Genetic Diseases, Inborn