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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 13, 2013

Interventions

  • Other: Training program
    • 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).

Arms, Groups and Cohorts

  • Experimental: Training program
    • 12-week strength and endurance training program

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cynthia Gagnon
  • Collaborator
    • Fondation du Grand défi Pierre Lavoie
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Cynthia Gagnon, Sponsor-Investigator – Université de Sherbrooke
  • Overall Official(s)
    • Cynthia Gagnon, Ph.D., Principal Investigator, Université de Sherbrooke

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