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出境医 / 临床实验 / Effects of a Multiple Component Training Program on Muscles in Adults With Myotonic Dystrophy Type 1

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

Study Description
Brief Summary:
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.

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

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official 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
Actual Study Start Date : July 23, 2013
Actual Primary Completion Date : December 13, 2013
Actual Study Completion Date : December 13, 2013
Arms and Interventions
Arm Intervention/treatment
Experimental: Training program
12-week strength and endurance training program
 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).
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Locations
Layout table for location information
Canada, Quebec
Groupe de recherche interdisciplinaire sur les maladies neuromusculaires
Saguenay, Quebec, Canada, G7X 7X2
Sponsors and Collaborators
Cynthia Gagnon
Fondation du Grand défi Pierre Lavoie
Investigators
Layout table for investigator information
Principal Investigator: Cynthia Gagnon, Ph.D. Université de Sherbrooke
Tracking Information
First Submitted Date  ICMJE June 21, 2019
First Posted Date  ICMJE June 28, 2019
Last Update Posted Date June 28, 2019
Actual Study Start Date  ICMJE July 23, 2013
Actual Primary Completion Date December 13, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of a Multiple Component Training Program on Muscles in Adults With Myotonic Dystrophy Type 1
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Myotonic Dystrophy 1
Intervention  ICMJE 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).
Study Arms  ICMJE Experimental: Training program
12-week strength and endurance training program
Intervention: Other: Training program
Publications * Roussel MP, Morin M, Girardin M, Fortin AM, Leone M, Mathieu J, Gagnon C, Duchesne E. Training program-induced skeletal muscle adaptations in two men with myotonic dystrophy type 1. BMC Res Notes. 2019 Aug 20;12(1):526. doi: 10.1186/s13104-019-4554-z.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2019) 		11
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 13, 2013
Actual Primary Completion Date December 13, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04001920
Other Study ID Numbers  ICMJE 2013-008
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cynthia Gagnon, Université de Sherbrooke
Study Sponsor  ICMJE Cynthia Gagnon
Collaborators  ICMJE Fondation du Grand défi Pierre Lavoie
Investigators  ICMJE
Principal Investigator: Cynthia Gagnon, Ph.D. Université de Sherbrooke
PRS Account Université de Sherbrooke
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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