Clinical trial NCT05036447: Myotonic Dystrophy Type 1 and Resistance Exercise
Official title: Recovery After Moderate-Heavy Resistance Exercise in Myotonic Dystrophy Type 1-patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myotonic Dystrophy 1
Keywords: Resistance exercise
Recovery
Muscle protein synthesis
Muscle protein breakdown
Muscle function
Lead sponsor: Norwegian School of Sport Sciences
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: University of Southern Denmark
name: University of Copenhagen
name: Maastricht University
name: University of Oslo
First posted: 2021-09-05
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Participants in both groups (patients and control) perform unilateral leg resistance exercise, contralateral leg serves as control
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate the response after one bout of moderate-heavy resistance exercise in patients suffering from Myotonic Dystrophy type 1. There is still doubt about if these patients could benefit from resistance exercise, or if this mode of exercise is detrimental to their mobility and health. We aim to monitor the subjects during the recovery phase and investigate recovery in several ways.

Detailed description: Myotonic dystrophy type 1 (DM1) is an autosomal, dominantly inherited, muscular disease and the most common muscular dystrophy amongst adults. The disease is characterized by progressive myopathy and myotonia, first evident in the distal parts of the body: calves and forearms, further progressing towards proximal parts. A recent review by Voet and co-workers (2013) concludes that exercise is safe for DM1-patients, and based on our current knowledge, DM1-patients should be able to gain positive adaptations from exercise. However, the physiological outcomes of an exercise stimulus are not well studied in this population and because of alterations in important Ca2+ handling systems the recovery processes might be significantly different from healthy muscles.

The aim of this study is to investigate the acute responses to moderate-heavy resistance exercise in DM1-patients. We aim to establish a timeline for recovery of muscle strength, measured as maximal voluntary contraction. In line with this, we want to investigate if any muscular damage has occurred with both direct and indirect measures, and possible mechanisms leading to muscle damage, i.e. impaired Ca2+ handling.

Eligibility criteria: Inclusion Criteria:

* Confirmed Myotonic Dystrophy type 1-diagnosis

Exclusion Criteria:

* Non-ambulatory
* Injuries to muscle-skeletal-system that prevents resistance exercise
* Severe affection of the cardiovascular system
* Cognitive affection
* Lives more than one hour from test site

Primary outcomes:
measure: Change in muscle strength
timeFrame: Baseline, and 5 minutes, 3 hours, 24 hours, 48 hours, and 71 hours after exercise
Secondary outcomes:
measure: Muscle protein synthesis rate
timeFrame: Baseline and 27 hours after final session of resistance exercise
measure: Muscle protein breakdown rate
timeFrame: Baseline and 27 hours after final session of resistance exercise
Other outcomes:
measure: Change in muscle damage
timeFrame: Baseline and 27 hours after final session of resistance exercise
measure: Change in muscle regeneration
timeFrame: Baseline and 27 hours after final session of resistance exercise
measure: Change in calcium cycling
timeFrame: Baseline and 27 hours after final session of resistance exercise
measure: Change in contractile function
timeFrame: Baseline and 27 hours after final session of resistance exercise
measure: Change in calcium-related protein abundances
timeFrame: Baseline and 27 hours after final session of resistance exercise
measure: Muscle fiber type
timeFrame: Baseline
measure: Muscle fiber type
timeFrame: 27 hours after final session of resistance exercise
measure: Change in heat shock proteins
timeFrame: Baseline and 27 hours after final session of resistance exercise
measure: Change in anabolic signaling
timeFrame: Baseline and 27 hours after final session of resistance exercise
measure: Change in autophagy
timeFrame: Baseline and 27 hours after final session of resistance exercise
measure: Change in biomarkers of muscle damage
timeFrame: Baseline, and 3 hours, 24 hours, 48 hours, 71 hours, and 96 hours after exercise
measure: Change in biomarker of muscle damage
timeFrame: Baseline, and 20 hours, 44 hours, 68 hours, and 92 hours after exercise
measure: Change in Fatigue
timeFrame: Baseline, and 1 hour after exercise
measure: Change in muscle stiffness
timeFrame: Baseline, and 50 minutes after exercise
measure: Change in muscle soreness
timeFrame: Baseline, and 3 hours, 24 hours, 48 hours, and 71 hours after exercise
measure: Change in muscle swelling
timeFrame: Baseline, and 3 hours, 24 hours, 48 hours, and 71 hours after exercise
Locations:
city: Oslo
country: Norway
facility: Norwegian School of Sport Sciences
Study officials:
affiliation: Norwegian School of Sport Sciences
name: Truls Raastad, PhD
role: PRINCIPAL_INVESTIGATOR
References: