NCT04001920

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 23, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2013

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 28, 2019

Completed
Last Updated

June 28, 2019

Status Verified

June 1, 2019

Enrollment Period

5 months

First QC Date

June 21, 2019

Last Update Submit

June 26, 2019

Conditions

Myotonic Dystrophy 1

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Change in 6 minute walking test disance

    Before and after the 12-week training program

  • 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 fatigue measured by the Fatigue severity 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

  • +7 more secondary outcomes

Study Arms (1)

Training program

EXPERIMENTAL

12-week strength and endurance training program

Other: Training program

Interventions

Training programOTHER

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).

Training program

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults with DM1
  • Walk without technical aid
  • Muscle impairment rating scale (MIRS) of 3 or 4

You may not qualify if:

  • Severe musculoskeletal disorders
  • Any medical contraindication to physical exercise
  • Any medical contraindication to muscle biopsies for the biopsy volunteers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe de recherche interdisciplinaire sur les maladies neuromusculaires

Saguenay, Quebec, G7X 7X2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 31429798DERIVED

MeSH Terms

Conditions

Myotonic Dystrophy

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesMyotonic DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesNervous System DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Cynthia Gagnon, Ph.D.

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

June 21, 2019

First Posted

June 28, 2019

Study Start

July 23, 2013

Primary Completion

December 13, 2013

Study Completion

December 13, 2013

Last Updated

June 28, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)