Myotonic Dystrophy Type 1 and Resistance Exercise

NCT ID: NCT05036447

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-14

Study Completion Date

2023-04-30

Brief Summary

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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

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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.

Conditions

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Myotonic Dystrophy 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Participants in both groups (patients and control) perform unilateral leg resistance exercise, contralateral leg serves as control
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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DM1-Ex

Moderate-heavy resistance exercise of one leg in DM1-patients

Group Type EXPERIMENTAL

Moderate-Heavy Resistance Exercise

Intervention Type OTHER

Leg press: 3 x 8 repetitions at 75% of 1 repetition maximum, 3 minutes rest between sets.

Knee extension: 3 x 6 repetitions at 85% of 1 repetition maximum, 3 minutes rest between sets.

DM1-Rest

Control leg (i.e. no exercise) in DM1-patients

Group Type NO_INTERVENTION

No interventions assigned to this group

Ctrl-Ex

Moderate-heavy resistance exercise of one leg in healthy participants

Group Type EXPERIMENTAL

Moderate-Heavy Resistance Exercise

Intervention Type OTHER

Leg press: 3 x 8 repetitions at 75% of 1 repetition maximum, 3 minutes rest between sets.

Knee extension: 3 x 6 repetitions at 85% of 1 repetition maximum, 3 minutes rest between sets.

Ctrl-Rest

Control leg (i.e. no exercise) in healthy participants

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Moderate-Heavy Resistance Exercise

Leg press: 3 x 8 repetitions at 75% of 1 repetition maximum, 3 minutes rest between sets.

Knee extension: 3 x 6 repetitions at 85% of 1 repetition maximum, 3 minutes rest between sets.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

Maastricht University

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role collaborator

Norwegian School of Sport Sciences

OTHER

Sponsor Role lead

Responsible Party

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Truls Raastad

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Truls Raastad, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian School of Sport Sciences

Locations

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Norwegian School of Sport Sciences

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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STYRK DM1

Identifier Type: -

Identifier Source: org_study_id