MedDataX Logo

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

NCT ID: NCT04018820

Last Updated: 2021-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-06-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myotonic Dystrophy 1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

Participants had to complete a 12-week strength training program and return to their normal activities for the following 6 months after the end of the training program
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Most outcomes where not masked, however the outcome assessor was masked for all muscle biopsy analysis: while analysing the muscle biopsy outcomes, the outcome assessor did not know if it was from baseline or from after the training program.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Training program

Group Type EXPERIMENTAL

Training program

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Élise Duchesne

OTHER

Sponsor Role lead

Fondation du Grand défi Pierre Lavoie

UNKNOWN

Sponsor Role collaborator

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Élise Duchesne

Sponsor-Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elise Duchesne, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Université du Québec à Chicoutimi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Groupe de recherche interdisciplinaire sur les maladies neuromusculaires

Saguenay, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-005

Identifier Type: -

Identifier Source: org_study_id