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Clinical Trials/NCT04001920
NCT04001920CompletedNot Applicable

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

Cynthia Gagnon1 site in 1 country11 target enrollmentStarted: July 23, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
11
Locations
1
Primary Endpoint
Change in maximal muscle strength in the knee extensors measured by quantified muscle testing

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Training program

Experimental

12-week strength and endurance training program

Intervention: Training program (Other)

Outcomes

Primary Outcomes

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

  • Changes in muscle biopsy-leucocyte infiltration(Before and after the 12-week training program for volunteers)
  • Change in 6 minute walking test disance(Before and after the 12-week training program)
  • Changes in quality of life measured by the 36-Item Short Form Survey (SF-36)(Before and after the 12-week training program)
  • Changes in muscle biopsy-muscle fiber size(Before and after the 12-week training program for volunteers)
  • Changes in functional capacity measured by the UQAM-YMCA test(Before and after the 12-week training program)
  • Changes in sprint capacity measured by the Running-base anaerobic sprint test(Before and after the 12-week training program)
  • Changes in stumbles and falls measured by the Falls efficacy scale(Before and after the 12-week training program)
  • Changes in daytime sleepiness measured by the Daytime sleepiness scale (Epworth Sleepiness Scale)(Before and after the 12-week training program)
  • Changes in life habits measured by questionnaire(Before and after the 12-week training program)
  • Changes in muscle biopsy-proportion of centrally nuclated fibers(Before and after the 12-week training program for volunteers)
  • Changes in fatigue measured by the Fatigue severity scale(Before and after the 12-week training program)
  • Changes in muscle biopsy-muscle fiber typing(Before and after the 12-week training program for volunteers)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Cynthia Gagnon

Sponsor-Investigator

Université de Sherbrooke

Study Sites (1)

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