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

NCT04018820 | Completed

• 1 other identifier: 2017-005
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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 measured by quantified muscle testing using a handheld dynamometer

  At baseline, week 6, week 12, month 6 and month 9

Secondary Outcomes (23)

• 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 ankle dorsiflexors

  At baseline and week 12

• Changes in 1-repetition maximum strength of the leg extension exercise

  At baseline, week 6 and week 12

Study Arms (1)

Training program

EXPERIMENTAL

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 were performed between 6 and 8 maximal repetitions.

Training program

Eligibility Criteria

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

You may qualify if:

• 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.

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

• Élise Duchesne: lead
• Fondation du Grand défi Pierre Lavoie: 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 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: 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

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 15, 2019
• Study Start: July 1, 2017
• Primary Completion: June 22, 2018
• Study Completion: June 22, 2018
• Last Updated: December 15, 2021

Record last verified: 2021-12

Locations

CA (1)