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

Primary Purpose

Myotonic Dystrophy 1

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Training program
Sponsored by
Cynthia Gagnon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myotonic Dystrophy 1

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Groupe de recherche interdisciplinaire sur les maladies neuromusculaires

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Training program

Arm Description

12-week strength and endurance training program

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in 6 minute walking test disance
Walking endurance change measured by the 6 minute walking test distance.
Changes in functional capacity measured by the UQAM-YMCA test
Functional capacity evaluated by 18 functional tests
Changes in sprint capacity measured by the Running-base anaerobic sprint test
Sprint capacity changes measured by the running-base anaerobic sprint test
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.
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.
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.
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.
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.
Changes in muscle biopsy-muscle fiber size
To assess changes in muscle fiber size
Changes in muscle biopsy-muscle fiber typing
To assess changes in muscle fiber typing
Changes in muscle biopsy-proportion of centrally nuclated fibers
To assess changes in muscle centrally nucleated fibers proportion
Changes in muscle biopsy-leucocyte infiltration
To assess changes in muscle fiber leucocyte infiltration

Full Information

First Posted
June 21, 2019
Last Updated
June 26, 2019
Sponsor
Cynthia Gagnon
Collaborators
Fondation du Grand défi Pierre Lavoie
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1. Study Identification

Unique Protocol Identification Number
NCT04001920
Brief Title
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
July 23, 2013 (Actual)
Primary Completion Date
December 13, 2013 (Actual)
Study Completion Date
December 13, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cynthia Gagnon
Collaborators
Fondation du Grand défi Pierre Lavoie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myotonic Dystrophy 1

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Gagnon, Ph.D.
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe de recherche interdisciplinaire sur les maladies neuromusculaires
City
Saguenay
State/Province
Quebec
ZIP/Postal Code
G7X 7X2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31429798
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.
Results Reference
derived

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

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