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

NCT ID: NCT05400629

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-01-10

Brief Summary

20 women with myotonic dystrophy type 1 (DM1) will complete a 12-week lower-limb strength training program. The training program consist 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 will be closely supervise and take place twice a week. It is hypothesize that the training program will induce muscular hypertrophy despite the genetic defect. The training program should also have positive effects on function. The participants will be evaluated at baseline, week 6, week 12, month 6 and month 9 to quantify the effects of the training program and if these effects will be maintained over time.

Conditions

Myotonic Dystrophy 1

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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 will be perform between 6 and 8 maximal repetitions.

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 will be perform between 6 and 8 maximal repetitions.

Interventions

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 will be perform between 6 and 8 maximal repetitions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• DM1 diagnosis must be confirmed by genetic analysis;
• Women sex, 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: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rare Disease Foundation

UNKNOWN

Sponsor Role: collaborator

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Élise Duchesne

Professor Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elise Duchesne, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Université du Québec à Chicoutimi

Locations

Groupe de recherche interdisciplinaire sur les maladies neuromusculaires

Saguenay, Quebec, Canada

Countries

Canada

Other Identifiers

2022-005

Identifier Type: -

Identifier Source: org_study_id