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Completed

NCT Number: NCT04001920

Effects of a Multiple Component Training Program on Muscles in Adults With Myotonic Dystrophy Type 1

A strength and endurance training program was conducted in adults with myotonic dystrophy type 1 (DM1). Participants underwent a 12-week/18-session supervised training program consisted of 6 exercises: elbow flexion/extension, shoulder horizontal adduction, leg press, and knee flexion/extension. To offer a complete training program aimed at improving function it was divided: the first 6 weeks were dedicated to strength-training, whereas the following weeks focused on endurance-training. To evaluate the effects of the training program, participants completed maximal strength, endurance and functional evaluations. Volunteers could also add a muscle biopsy at the beginning and the end of the program to evaluate physiological parameters.

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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

20 year–60 year

Sex eligibility

All sexes

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

  • Adults with DM1
  • Walk without technical aid
  • Muscle impairment rating scale (MIRS) of 3 or 4

Exclusion criteria

  • Severe musculoskeletal disorders
  • Any medical contraindication to physical exercise
  • Any medical contraindication to muscle biopsies for the biopsy volunteers

Treatment and study plan

Training program

Other

12-week, 18-session training program. To offer a complete training program aimed at improving function it was divided : the first 6 weeks were dedicated to strength-training (2 sets of 6 repetitions at 80% of 1-RM), whereas the following weeks focused on endurance-training (1 set of 25 repetitions at 40% of 1-RM).

Primary outcomes

  1. Change in maximal muscle strength in the knee extensors measured by quantified muscle testing

    Time frame: Before and after the 12-week training program

    Changes in knee extensor maximal muscle strength evaluated by quantified muscle testing with a handheld dynamometer.

Secondary outcomes

  1. Change in 6 minute walking test disance

    Time frame: Before and after the 12-week training program

    Walking endurance change measured by the 6 minute walking test distance.

  2. Changes in functional capacity measured by the UQAM-YMCA test

    Time frame: Before and after the 12-week training program

    Functional capacity evaluated by 18 functional tests

  3. Changes in sprint capacity measured by the Running-base anaerobic sprint test

    Time frame: Before and after the 12-week training program

    Sprint capacity changes measured by the running-base anaerobic sprint test

  4. Changes in fatigue measured by the Fatigue severity scale

    Time frame: Before and after the 12-week training program

    Fatigue questionnaire: 9-item questionnaire rated on a scale from 1 to 7 for each item. A score a higher score means more fatigue.

  5. Changes in daytime sleepiness measured by the Daytime sleepiness scale (Epworth Sleepiness Scale)

    Time frame: Before and after the 12-week training program

    8-item questionnaire, rated on a scale from 0 to 3 for each item, the higher the score, the more the patient has daytime sleepiness.

  6. Changes in stumbles and falls measured by the Falls efficacy scale

    Time frame: Before and after the 12-week training program

    10-item questionnaire about stumbles and falls. All items are rated on a 10-point scale. A higher score means a higher fear of falling. A score over 70 means a significant fear of falling.

  7. Changes in quality of life measured by the 36-Item Short Form Survey (SF-36)

    Time frame: Before and after the 12-week training program

    36-item quality of life questionnaire. The final score is calculated on a total of 100 where the lower the score, the more disability. A score of 100 means no disability.

  8. Changes in life habits measured by questionnaire

    Time frame: Before and after the 12-week training program

    Life habits questionnaire Assessment of life habits is a 77-item questionnaire with a scale from 0 to 9 for each item. A higher score means no disability and a low score means more disability.

  9. Changes in muscle biopsy-muscle fiber size

    Time frame: Before and after the 12-week training program for volunteers

    To assess changes in muscle fiber size

  10. Changes in muscle biopsy-muscle fiber typing

    Time frame: Before and after the 12-week training program for volunteers

    To assess changes in muscle fiber typing

  11. Changes in muscle biopsy-proportion of centrally nuclated fibers

    Time frame: Before and after the 12-week training program for volunteers

    To assess changes in muscle centrally nucleated fibers proportion

  12. Changes in muscle biopsy-leucocyte infiltration

    Time frame: Before and after the 12-week training program for volunteers

    To assess changes in muscle fiber leucocyte infiltration

Sponsors and collaborators

Lead sponsor

Cynthia Gagnon

Other

Collaborators

  • Fondation du Grand défi Pierre Lavoie

Registry information

Official study title

Effects of a Multiple Component Training Program on Muscles, Maximal Muscle Strength, Endurance and Functional Performance in Adults With Myotonic Dystrophy Type 1: A Pilot Study

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 28, 2019
Registry last updated
Jun 28, 2019

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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