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

NCT05400629 | Completed

• 1 other identifier: 2022-005
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Changes in maximal isometric muscle strength of the knee extensors

  Changes in maximal isometric muscle strength of the knee extensors measure by quantify muscle testing using a handheld dynamometer

  At baseline, week 6, week 12, month 3 and month 6

Secondary Outcomes (37)

• Changes in maximal isometric muscle strength of the knee flexors

  At baseline and week 12

• Changes in maximal isometric muscle strength of the hip flexors

  At baseline and week 12

• Changes in maximal isometric muscle strength of the hip extensors

  At baseline and week 12

• Changes in maximal isometric muscle strength of the hip abductors

  At baseline and week 12

• Changes in maximal isometric muscle strength of the ankle dorsiflexors

  At baseline and week 12

Study Arms (1)

Training program

EXPERIMENTAL

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.

Other: Training program

Interventions

Training program 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.

Training program

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Rare Disease Foundation: collaborator

Study Sites (1)

Groupe de recherche interdisciplinaire sur les maladies neuromusculaires

Saguenay, Quebec, G7X 7X2, Canada

Location

MeSH Terms

Conditions

Myotonic Dystrophy

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Myotonic Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Elise Duchesne, Ph.D

  Université du Québec à Chicoutimi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Most outcomes will not be mask, however the outcome assessor will be mask for all muscle biopsy analysis: while analysing the muscle biopsy outcomes, the outcome assessor will not know if it was from baseline or from after the training program.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Investigator

Model Details: Participants will 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.

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 1, 2022
• Study Start: January 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: January 10, 2023
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

CA (1)