Effects of a 12-week Strength Training Program in Men With Myotonic Dystrophy Type 1

December 6, 2021 updated by: Élise Duchesne
Eleven men with myotonic dystrophy type 1 (DM1) underwent a 12-week lower-limb strength training program. The training program consisted of 3 series of 6 to 8 maximal repetitions of 5 different exercises: Leg extension, leg press, hip abduction, squat and plantar flexion. Training sessions were closely supervised and took place twice a week. It is hypothesised that the training program will induce muscular hypertrophy despite the genetic defect. The training program should also have positive effects on function. The participants were evaluated at baseline, week 6, week 12, month 6 and month 9 to see the effects of the training program and if these effects are maintained over time.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Saguenay, Quebec, Canada, G7X 7X2
        • Groupe de recherche interdisciplinaire sur les maladies neuromusculaires

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • DM1 diagnosis must be confirmed by genetic analysis;
  • Male gender, aged between 30 and 65 years old;
  • Be able to walk without assistance;
  • Consent of the neurologist must be given to participate in this study;
  • Must reside in the Saguenay-Lac-St-Jean region;
  • Subjects must be able to give their consent freely and voluntarily.

Exclusion Criteria:

  • Patients with any other form of muscular dystrophy are excluded;
  • Any contraindication for strenuous exercise or muscle biopsy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Training program
Other: Training program
12-week strength training program of the lower limbs consisting of 5 different exercises: Leg extension, leg press, hip abduction, squat and plantar flexion. All exercises were performed between 6 and 8 maximal repetitions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in maximal isometric muscle strength of the knee extensors
Time Frame: At baseline, week 6, week 12, month 6 and month 9
Changes in maximal isometric muscle strength of the knee extensors measured by quantified muscle testing using a handheld dynamometer
At baseline, week 6, week 12, month 6 and month 9

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in maximal isometric muscle strength of the knee flexors
Time Frame: At baseline and week 12
Changes in maximal isometric muscle strength of the knee flexors measured by quantified muscle testing using a handheld dynamometer
At baseline and week 12
Changes in maximal isometric muscle strength of the hip flexors
Time Frame: At baseline and week 12
Changes in maximal isometric muscle strength of the hip flexors measured by quantified muscle testing using a handheld dynamometer
At baseline and week 12
Changes in maximal isometric muscle strength of the hip extensors
Time Frame: At baseline and week 12
Changes in maximal isometric muscle strength of the hip extensors measured by quantified muscle testing using a handheld dynamometer
At baseline and week 12
Changes in maximal isometric muscle strength of the ankle dorsiflexors
Time Frame: At baseline and week 12
Changes in maximal isometric muscle strength of the ankle dorsiflexors measured by quantified muscle testing using a handheld dynamometer
At baseline and week 12
Changes in 1-repetition maximum strength of the leg extension exercise
Time Frame: At baseline, week 6 and week 12
Changes in 1-repetition maximum strength of the leg extension exercise
At baseline, week 6 and week 12
Changes in 1-repetition maximum strength of the leg press exercise
Time Frame: At baseline, week 6 and week 12
Changes in 1-repetition maximum strength of the leg press exercise
At baseline, week 6 and week 12
Changes in 1-repetition maximum strength of the hip abduction exercise
Time Frame: At baseline, week 6 and week 12
Changes in 1-repetition maximum strength of the hip abduction exercise
At baseline, week 6 and week 12
Changes in 1-repetition maximum strength of the squat exercise
Time Frame: At baseline, week 6 and week 12
Changes in 1-repetition maximum strength of the squat exercise
At baseline, week 6 and week 12
Changes in comfortable walking speed in the 10-meter walk test
Time Frame: At baseline, week 6, week 12, month 6 and month 9
Changes in comfortable walking speed in the 10-meter walk test
At baseline, week 6, week 12, month 6 and month 9
Changes in maximal walking speed in the 10-meter walk test
Time Frame: At baseline, week 6, week 12, month 6 and month 9
Changes in maximal walking speed in the 10-meter walk test
At baseline, week 6, week 12, month 6 and month 9
Changes in the number of repetitions in the 30-seconds sit-to-stand test
Time Frame: At baseline, week 6, week 12, month 6 and month 9
Changes in the number of repetitions in the 30-seconds sit-to-stand test
At baseline, week 6, week 12, month 6 and month 9
Changes in the score of the lower extremity functional scale
Time Frame: At baseline, week 12, month 6 and month 9
Changes in the score of the lower extremity functional scale (LEFS). The LEFS is an 80-point questionnaire with 20 items scored from 0 to 4. A score of 80 means no disfunction while a score of 0 means maximal disfunction.
At baseline, week 12, month 6 and month 9
Changes in the score of the myotonic dystrophy health index
Time Frame: At baseline, week 6, week 12, month 6 and month 9
Changes in the score of the myotonic dystrophy health index (MDHI). The MDHI is a 114-item questionnaire scored from 0 to 100, where 0 means no disability and 100 means maximal disability.
At baseline, week 6, week 12, month 6 and month 9
Changes in the score of the Fatigue and Daytime Sleepiness Scale
Time Frame: At baseline, week 6, week 12, month 6 and month 9
Changes in the score of the Fatigue and Daytime Sleepiness Scale (FDSS). The FDSS is a 12-item questionnaire where all questions are scored from 0 to 2. A higher score means more daytime sleepiness and fatigue.
At baseline, week 6, week 12, month 6 and month 9
Changes in the Marin apathy scale
Time Frame: At baseline, week 12, month 6 and month 9
Changes in the Marin apathy scale. The Marin apathy scale is scored by the clinician where he interviews the subject and then scores an 18-item list on a scale of 1 to 4. A high score means more apathy.
At baseline, week 12, month 6 and month 9
Changes in the Well-Being Manifestations Measure Scale
Time Frame: At baseline, week 6, week 12 and month 6
Changes in the Well-Being Manifestations Measure Scale (WBMMS). The WBMMS is a 25-item questionnaire where each question is scored on a scale from 1 to 5. A high score means high well-being.
At baseline, week 6, week 12 and month 6
Changes in the Hospital Anxiety and Depression Scale
Time Frame: At baseline, week 6, week 12 and month 6
Changes in the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item questionnaire with a scale from 0 to 3 for each item. A high score means high depression and anxiety.
At baseline, week 6, week 12 and month 6
Changes in muscle biopsy of the vastus lateralis: muscle fiber typing
Time Frame: At baseline and week 12
Changes in muscle biopsy of the vastus lateralis: muscle fiber typing
At baseline and week 12
Changes in muscle biopsy of the vastus lateralis: muscle fiber size
Time Frame: At baseline and week 12
Changes in muscle biopsy of the vastus lateralis: muscle fiber size (smallest diameter of the fiber)
At baseline and week 12
Changes in muscle biopsy of the vastus lateralis: muscle proteomics
Time Frame: At baseline and week 12
Changes in muscle biopsy of the vastus lateralis: muscle proteomics (protein expression)
At baseline and week 12
Changes in muscle biopsy of the vastus lateralis: muscle transcriptomics
Time Frame: At baseline and week 12
Changes in muscle biopsy of the vastus lateralis: muscle transcriptomics (RNA expression analysis)
At baseline and week 12
Changes in muscle biopsy of the vastus lateralis: mitochondrial function
Time Frame: At baseline and week 12
Changes in muscle biopsy of the vastus lateralis: mitochondrial function. Analysis of mitochondrial markers and enzymes
At baseline and week 12
Changes in muscle biopsy of the vastus lateralis: Nuclear foci
Time Frame: At baseline and week 12
Changes in muscle biopsy of the vastus lateralis: Nuclear foci (changes in accumulation of nuclear foci)
At baseline and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Élise Duchesne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fondation du Grand défi Pierre Lavoie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elise Duchesne, Ph.D., Université du Québec à Chicoutimi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 22, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 22, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings