Clinical trial NCT04001920: Effects of a Multiple Component Training Program on Muscles in Adults With Myotonic Dystrophy Type 1
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myotonic Dystrophy 1
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Fondation du Grand défi Pierre Lavoie
First posted: 2019-06-28
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Change in maximal muscle strength in the knee extensors measured by quantified muscle testing
timeFrame: Before and after the 12-week training program
Secondary outcomes:
measure: Change in 6 minute walking test disance
timeFrame: Before and after the 12-week training program
measure: Changes in functional capacity measured by the UQAM-YMCA test
timeFrame: Before and after the 12-week training program
measure: Changes in sprint capacity measured by the Running-base anaerobic sprint test
timeFrame: Before and after the 12-week training program
measure: Changes in fatigue measured by the Fatigue severity scale
timeFrame: Before and after the 12-week training program
measure: Changes in daytime sleepiness measured by the Daytime sleepiness scale (Epworth Sleepiness Scale)
timeFrame: Before and after the 12-week training program
measure: Changes in stumbles and falls measured by the Falls efficacy scale
timeFrame: Before and after the 12-week training program
measure: Changes in quality of life measured by the 36-Item Short Form Survey (SF-36)
timeFrame: Before and after the 12-week training program
measure: Changes in life habits measured by questionnaire
timeFrame: Before and after the 12-week training program
measure: Changes in muscle biopsy-muscle fiber size
timeFrame: Before and after the 12-week training program for volunteers
measure: Changes in muscle biopsy-muscle fiber typing
timeFrame: Before and after the 12-week training program for volunteers
measure: Changes in muscle biopsy-proportion of centrally nuclated fibers
timeFrame: Before and after the 12-week training program for volunteers
measure: Changes in muscle biopsy-leucocyte infiltration
timeFrame: Before and after the 12-week training program for volunteers
Other outcomes:
Locations:
city: Saguenay
country: Canada
facility: Groupe de recherche interdisciplinaire sur les maladies neuromusculaires
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Cynthia Gagnon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.