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

Myotonic Dystrophy 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04001920
• Other study ID #: 2013-008
• Status: Completed
• Phase: N/A
• Start date: July 23, 2013
• Est. completion date: December 13, 2013

Study information

• Verified date: June 2019
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 13, 2013
• Est. primary completion date: December 13, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Myotonic Dystrophy
• Myotonic Dystrophy 1

Intervention

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).

Locations

Country	Name	City	State
Canada	Groupe de recherche interdisciplinaire sur les maladies neuromusculaires	Saguenay	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Cynthia Gagnon	Fondation du Grand défi Pierre Lavoie

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in maximal muscle strength in the knee extensors measured by quantified muscle testing	Changes in knee extensor maximal muscle strength evaluated by quantified muscle testing with a handheld dynamometer.	Before and after the 12-week training program
Secondary	Change in 6 minute walking test disance	Walking endurance change measured by the 6 minute walking test distance.	Before and after the 12-week training program
Secondary	Changes in functional capacity measured by the UQAM-YMCA test	Functional capacity evaluated by 18 functional tests	Before and after the 12-week training program
Secondary	Changes in sprint capacity measured by the Running-base anaerobic sprint test	Sprint capacity changes measured by the running-base anaerobic sprint test	Before and after the 12-week training program
Secondary	Changes in fatigue measured by the Fatigue severity scale	Fatigue questionnaire: 9-item questionnaire rated on a scale from 1 to 7 for each item. A score a higher score means more fatigue.	Before and after the 12-week training program
Secondary	Changes in daytime sleepiness measured by the Daytime sleepiness scale (Epworth Sleepiness Scale)	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.	Before and after the 12-week training program
Secondary	Changes in stumbles and falls measured by the Falls efficacy scale	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.	Before and after the 12-week training program
Secondary	Changes in quality of life measured by the 36-Item Short Form Survey (SF-36)	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.	Before and after the 12-week training program
Secondary	Changes in life habits measured by questionnaire	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.	Before and after the 12-week training program
Secondary	Changes in muscle biopsy-muscle fiber size	To assess changes in muscle fiber size	Before and after the 12-week training program for volunteers
Secondary	Changes in muscle biopsy-muscle fiber typing	To assess changes in muscle fiber typing	Before and after the 12-week training program for volunteers
Secondary	Changes in muscle biopsy-proportion of centrally nuclated fibers	To assess changes in muscle centrally nucleated fibers proportion	Before and after the 12-week training program for volunteers
Secondary	Changes in muscle biopsy-leucocyte infiltration	To assess changes in muscle fiber leucocyte infiltration	Before and after the 12-week training program for volunteers