Myotonic Dystrophy 1STYRK DM1NCT05036447
Myotonic Dystrophy Type 1 and Resistance Exercise
A study testing Moderate-Heavy Resistance Exercise in people with Myotonic Dystrophy 1, run by Norwegian School of Sport Sciences at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Myotonic Dystrophy 1
- What is being tested?
- Moderate-Heavy Resistance Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteNorway
- Study dates
- 14 Jun 2021to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Confirmed Myotonic Dystrophy type 1-diagnosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recovery After Moderate-Heavy Resistance Exercise in Myotonic Dystrophy Type 1-patients
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.
Read the 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.
- Conditions
- Myotonic Dystrophy 1
- Being tested
- Moderate-Heavy Resistance Exercise
- Keywords
- Resistance exercise, Recovery, Muscle protein synthesis, Muscle protein breakdown, Muscle function
- Medical subject headings
- Myotonic Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-Heavy Resistance ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| DM1-Ex | Experimental | Moderate-heavy resistance exercise of one leg in DM1-patients Receives: Other: Moderate-Heavy Resistance Exercise |
| DM1-Rest | No intervention | Control leg (i.e. no exercise) in DM1-patients |
| Ctrl-Ex | Experimental | Moderate-heavy resistance exercise of one leg in healthy participants Receives: Other: Moderate-Heavy Resistance Exercise |
| Ctrl-Rest | No intervention | Control leg (i.e. no exercise) in healthy participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle strength
Recovery of knee extension torque
Measured: Baseline, and 5 minutes, 3 hours, 24 hours, 48 hours, and 71 hours after exercise
Secondary outcomes (2)
Muscle protein synthesis rate
Rate of muscle protein synthesis in m. vastus lateralis between baseline and 27 hours after final session of resistance exercise
Measured: Baseline and 27 hours after final session of resistance exercise
Muscle protein breakdown rate
Rate of muscle protein breakdown in m. vastus lateralis between baseline and 27 hours after final session of resistance exercise
Measured: Baseline and 27 hours after final session of resistance exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start14 Jun 2021
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myotonic Dystrophy 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Participants in both groups (patients and control) perform unilateral leg resistance exercise, contralateral leg serves as control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian School of Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, University of Southern Denmark, University of Copenhagen, Maastricht University, University of Oslo
- Responsible party
- Principal investigator, Truls Raastad, Norwegian School of Sport Sciences
- Investigators
- Truls Raastad, PhD, Principal investigator, Norwegian School of Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036447
- Sponsor's protocol ID
- STYRK DM1
- Acronym
- STYRK DM1
- Status last verified
- Nov 2023
- First submitted
- 10 May 2021
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery After Moderate-Heavy Resistance Exercise in Myotonic Dystrophy Type 1-patients
- ClinicalTrials.gov ID
- NCT05036447
- Acronym / sponsor ID
- STYRK DM1 / STYRK DM1
- Conditions
- Myotonic Dystrophy 1
- Keywords
- Resistance exercise, Recovery, Muscle protein synthesis, Muscle protein breakdown, Muscle function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Norwegian School of Sport SciencesUniversity, hospital or other
- Collaborators
- Oslo University Hospital, University of Southern Denmark, University of Copenhagen, Maastricht University, University of Oslo
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Participants in both groups (patients and control) perform unilateral leg resistance exercise, contralateral leg serves as control
| Arm | Type | Receives |
|---|---|---|
| DM1-Ex | Experimental | Other: Moderate-Heavy Resistance ExerciseModerate-heavy resistance exercise of one leg in DM1-patients |
| DM1-Rest | No intervention | –Control leg (i.e. no exercise) in DM1-patients |
| Ctrl-Ex | Experimental | Other: Moderate-Heavy Resistance ExerciseModerate-heavy resistance exercise of one leg in healthy participants |
| Ctrl-Rest | No intervention | –Control leg (i.e. no exercise) in healthy participants |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Confirmed Myotonic Dystrophy type 1-diagnosis
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate-Heavy Resistance ExerciseLeg 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. | Other | Ctrl-Ex, DM1-Ex |
Primary outcome
Change in muscle strength
Time frame: Baseline, and 5 minutes, 3 hours, 24 hours, 48 hours, and 71 hours after exercise
Recovery of knee extension torque
2 secondary outcomes
Muscle protein synthesis rate
Time frame: Baseline and 27 hours after final session of resistance exercise
Muscle protein breakdown rate
Time frame: Baseline and 27 hours after final session of resistance exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Truls Raastad, PhD principal investigator
Norwegian School of Sport Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-Heavy Resistance Exercise in people with Myotonic Dystrophy 1, run by Norwegian School of Sport Sciences at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle strength (time frame: Baseline, and 5 minutes, 3 hours, 24 hours, 48 hours, and 71 hours after exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.