Myotonic Dystrophy Type 1 Aerobic Exercise Study

NCT04187482 | Completed DMC

• 1 other identifier: 7091
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Myotonic dystrophy type 1 (DM1) is a genetic disease that primarily targets skeletal muscle resulting in severe weakness and muscle loss. As a result, individuals suffering from DM1 become very inactive and lose mobility resulting in a lower quality of life. This study will investigate the effect of a 12-week moderate intensity exercise protocol on skeletal muscle function and cellular benefits in DM1 patients.

Conditions

Myotonic Dystrophy 1; Muscular Dystrophies

Keywords

aerobic exercise

Outcome Measures

Primary Outcomes (1)

• Maximal aerobic capacity

  VO2max in mL/min/kg-1

  3 months from enrolment

Secondary Outcomes (8)

• 6 minute walk test

  3 months from enrolment

• 5x sit to stand

  3 months from enrolment

• timed up and go

  3 months from enrolment

• Leg muscle strength

  3 months from enrolment

• Grip strength

  3 months from enrolment

Study Arms (1)

Exercise training group

EXPERIMENTAL

All participants will be receiving same exercise training intervention

Other: Exercise training

Interventions

Exercise training OTHER

All participants with DM1 will undergo a 12-week aerobic exercise training intervention on a cycle ergometer

Exercise training group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• DM1 participants:
• Male or female clinically diagnosed with DM1
• CTG repeats 100-1000
• Normal weight (BMI 18.5 - 24.9 kg/m2) or overweight (BMI 25 - 29.9 kg/m2)
• Age matched controls:
• Healthy men and women
• Normal weight (BMI 18.5 - 24.9 kg/m2) or overweight (BMI 25 - 29.9 kg/m2)
• Physically inactive (\< 1-2 hour of formal exercise/week)

You may not qualify if:

• Smoking
• Obese (BMI \> 30.0 kg/m2)
• Use of narcotic analgesic or anti-inflammatory drugs
• Type 1 or 2 diabetes (more than one anti-diabetic drug)
• Cardiovascular disease (recent myocardial infarction (\< 6 months))
• Uncontrolled hypertension requiring more than 2 medications
• Congestive heart failure requiring more than one medication for control-
• Known liver disease
• Cognitive impairments limiting ability to provide informed consent
• Active musculoskeletal injuries and/or severe osteoarthritis

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University Medical Center

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (1)

• Mikhail AI, Nagy PL, Manta K, Rouse N, Manta A, Ng SY, Nagy MF, Smith P, Lu JQ, Nederveen JP, Ljubicic V, Tarnopolsky MA. Aerobic exercise elicits clinical adaptations in myotonic dystrophy type 1 patients independently of pathophysiological changes. J Clin Invest. 2022 May 16;132(10):e156125. doi: 10.1172/JCI156125.

  PMID: 35316212 DERIVED

MeSH Terms

Conditions

Myotonic Dystrophy; Muscular Dystrophies

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor, Director of Neuromuscular and Neurometabolic Clinic

Model Details: Participants are undergoing 12-weeks of aerobic exercise training

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 5, 2019
• Study Start: December 6, 2019
• Primary Completion: March 29, 2020
• Study Completion: November 1, 2021
• Last Updated: March 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)