Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 51 for:    Myotonic Dystrophy

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04001920
Recruitment Status : Completed
First Posted : June 28, 2019
Last Update Posted : June 28, 2019
Sponsor:
Collaborator:
Fondation du Grand défi Pierre Lavoie
Information provided by (Responsible Party):
Cynthia Gagnon, Université de Sherbrooke

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
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


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).




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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): NCT04001920


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Cynthia Gagnon, Sponsor-Investigator, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT04001920     History of Changes
Other Study ID Numbers: 2013-008
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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