Myotonic Dystrophy 1NCT04018820
Effects of a 12-week Strength Training Program in Men With Myotonic Dystrophy Type 1
A study testing Training program in people with Myotonic Dystrophy 1, run by Élise Duchesne at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men only
- Conditions the study is for
- Myotonic Dystrophy 1
- What is being tested?
- Training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2017to 22 Jun 2018
- 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 30 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with any other form of muscular dystrophy are excluded;
- Any contraindication for strenuous exercise or muscle biopsy.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Groupe de recherche interdisciplinaire sur les maladies neuromusculaires
Saguenay, Quebec, G7X 7X2
About this study
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
- Being tested
- Training program
- Medical subject headings
- Myotonic Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Training program | Experimental | Not described Receives: Other: Training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline, week 6, week 12, month 6 and month 9
Secondary outcomes (23)
Changes in maximal isometric muscle strength of the knee flexors
Changes in maximal isometric muscle strength of the knee flexors measured by quantified muscle testing using a handheld dynamometer
Measured: At baseline and week 12
Changes in maximal isometric muscle strength of the hip flexors
Changes in maximal isometric muscle strength of the hip flexors measured by quantified muscle testing using a handheld dynamometer
Measured: At baseline and week 12
Changes in maximal isometric muscle strength of the hip extensors
Changes in maximal isometric muscle strength of the hip extensors measured by quantified muscle testing using a handheld dynamometer
Measured: At baseline and week 12
Changes in maximal isometric muscle strength of the ankle dorsiflexors
Changes in maximal isometric muscle strength of the ankle dorsiflexors measured by quantified muscle testing using a handheld dynamometer
Measured: At baseline and week 12
Changes in 1-repetition maximum strength of the leg extension exercise
Changes in 1-repetition maximum strength of the leg extension exercise
Measured: At baseline, week 6 and week 12
Changes in 1-repetition maximum strength of the leg press exercise
Changes in 1-repetition maximum strength of the leg press exercise
Measured: At baseline, week 6 and week 12
Changes in 1-repetition maximum strength of the hip abduction exercise
Changes in 1-repetition maximum strength of the hip abduction exercise
Measured: At baseline, week 6 and week 12
Changes in 1-repetition maximum strength of the squat exercise
Changes in 1-repetition maximum strength of the squat exercise
Measured: At baseline, week 6 and week 12
Changes in comfortable walking speed in the 10-meter walk test
Changes in comfortable walking speed in the 10-meter walk test
Measured: At baseline, week 6, week 12, month 6 and month 9
Changes in maximal walking speed in the 10-meter walk test
Changes in maximal walking speed in the 10-meter walk test
Measured: At baseline, week 6, week 12, month 6 and month 9
Changes in the number of repetitions in the 30-seconds sit-to-stand test
Changes in the number of repetitions in the 30-seconds sit-to-stand test
Measured: At baseline, week 6, week 12, month 6 and month 9
Changes in the score of the lower extremity functional scale
Changes in the score of the lower extremity functional scale (LEFS). The LEFS is an 80-point questionnaire with 20 items scored from 0 to 4. A score of 80 means no disfunction while a score of 0 means maximal disfunction.
Measured: At baseline, week 12, month 6 and month 9
Changes in the score of the myotonic dystrophy health index
Changes in the score of the myotonic dystrophy health index (MDHI). The MDHI is a 114-item questionnaire scored from 0 to 100, where 0 means no disability and 100 means maximal disability.
Measured: At baseline, week 6, week 12, month 6 and month 9
Changes in the score of the Fatigue and Daytime Sleepiness Scale
Changes in the score of the Fatigue and Daytime Sleepiness Scale (FDSS). The FDSS is a 12-item questionnaire where all questions are scored from 0 to 2. A higher score means more daytime sleepiness and fatigue.
Measured: At baseline, week 6, week 12, month 6 and month 9
Changes in the Marin apathy scale
Changes in the Marin apathy scale. The Marin apathy scale is scored by the clinician where he interviews the subject and then scores an 18-item list on a scale of 1 to 4. A high score means more apathy.
Measured: At baseline, week 12, month 6 and month 9
Changes in the Well-Being Manifestations Measure Scale
Changes in the Well-Being Manifestations Measure Scale (WBMMS). The WBMMS is a 25-item questionnaire where each question is scored on a scale from 1 to 5. A high score means high well-being.
Measured: At baseline, week 6, week 12 and month 6
Changes in the Hospital Anxiety and Depression Scale
Changes in the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item questionnaire with a scale from 0 to 3 for each item. A high score means high depression and anxiety.
Measured: At baseline, week 6, week 12 and month 6
Changes in muscle biopsy of the vastus lateralis: muscle fiber typing
Changes in muscle biopsy of the vastus lateralis: muscle fiber typing
Measured: At baseline and week 12
Changes in muscle biopsy of the vastus lateralis: muscle fiber size
Changes in muscle biopsy of the vastus lateralis: muscle fiber size (smallest diameter of the fiber)
Measured: At baseline and week 12
Changes in muscle biopsy of the vastus lateralis: muscle proteomics
Changes in muscle biopsy of the vastus lateralis: muscle proteomics (protein expression)
Measured: At baseline and week 12
Changes in muscle biopsy of the vastus lateralis: muscle transcriptomics
Changes in muscle biopsy of the vastus lateralis: muscle transcriptomics (RNA expression analysis)
Measured: At baseline and week 12
Changes in muscle biopsy of the vastus lateralis: mitochondrial function
Changes in muscle biopsy of the vastus lateralis: mitochondrial function. Analysis of mitochondrial markers and enzymes
Measured: At baseline and week 12
Changes in muscle biopsy of the vastus lateralis: Nuclear foci
Changes in muscle biopsy of the vastus lateralis: Nuclear foci (changes in accumulation of nuclear foci)
Measured: At baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start1 Jul 2017
- Primary completion22 Jun 2018
- Study completion22 Jun 2018
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Élise Duchesne
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation du Grand défi Pierre Lavoie
- Responsible party
- Sponsor-investigator, Élise Duchesne, Université de Sherbrooke
- Investigators
- Elise Duchesne, Ph.D., Principal investigator, Université du Québec à Chicoutimi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018820
- Sponsor's protocol ID
- 2017-005
- Status last verified
- Dec 2021
- First submitted
- 9 Jul 2019
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 12-week Strength Training Program in Men With Myotonic Dystrophy Type 1
- ClinicalTrials.gov ID
- NCT04018820
- Acronym / sponsor ID
- 2017-005
- Conditions
- Myotonic Dystrophy 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Élise DuchesneUniversity, hospital or other
- Collaborators
- Fondation du Grand défi Pierre Lavoie
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 22 Jun 2018 (actual)
- Study completion
- 22 Jun 2018 (actual)
- First posted
- 15 Jul 2019 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Training program | Experimental | Other: Training program |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (2 listed)
- Patients with any other form of muscular dystrophy are excluded;
- Any contraindication for strenuous exercise or muscle biopsy.
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 |
|---|---|---|
| Training program12-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. | Other | Training program |
Primary outcome
Changes in maximal isometric muscle strength of the knee extensors
Time frame: At baseline, week 6, week 12, month 6 and month 9
Changes in maximal isometric muscle strength of the knee extensors measured by quantified muscle testing using a handheld dynamometer
23 secondary outcomes
Changes in maximal isometric muscle strength of the knee flexors
Time frame: At baseline and week 12
Changes in maximal isometric muscle strength of the hip flexors
Time frame: At baseline and week 12
Changes in maximal isometric muscle strength of the hip extensors
Time frame: At baseline and week 12
Changes in maximal isometric muscle strength of the ankle dorsiflexors
Time frame: At baseline and week 12
Changes in 1-repetition maximum strength of the leg extension exercise
Time frame: At baseline, week 6 and week 12
Changes in 1-repetition maximum strength of the leg press exercise
Time frame: At baseline, week 6 and week 12
Changes in 1-repetition maximum strength of the hip abduction exercise
Time frame: At baseline, week 6 and week 12
Changes in 1-repetition maximum strength of the squat exercise
Time frame: At baseline, week 6 and week 12
Changes in comfortable walking speed in the 10-meter walk test
Time frame: At baseline, week 6, week 12, month 6 and month 9
Changes in maximal walking speed in the 10-meter walk test
Time frame: At baseline, week 6, week 12, month 6 and month 9
Changes in the number of repetitions in the 30-seconds sit-to-stand test
Time frame: At baseline, week 6, week 12, month 6 and month 9
Changes in the score of the lower extremity functional scale
Time frame: At baseline, week 12, month 6 and month 9
Changes in the score of the myotonic dystrophy health index
Time frame: At baseline, week 6, week 12, month 6 and month 9
Changes in the score of the Fatigue and Daytime Sleepiness Scale
Time frame: At baseline, week 6, week 12, month 6 and month 9
Changes in the Marin apathy scale
Time frame: At baseline, week 12, month 6 and month 9
Changes in the Well-Being Manifestations Measure Scale
Time frame: At baseline, week 6, week 12 and month 6
Changes in the Hospital Anxiety and Depression Scale
Time frame: At baseline, week 6, week 12 and month 6
Changes in muscle biopsy of the vastus lateralis: muscle fiber typing
Time frame: At baseline and week 12
Changes in muscle biopsy of the vastus lateralis: muscle fiber size
Time frame: At baseline and week 12
Changes in muscle biopsy of the vastus lateralis: muscle proteomics
Time frame: At baseline and week 12
Changes in muscle biopsy of the vastus lateralis: muscle transcriptomics
Time frame: At baseline and week 12
Changes in muscle biopsy of the vastus lateralis: mitochondrial function
Time frame: At baseline and week 12
Changes in muscle biopsy of the vastus lateralis: Nuclear foci
Time frame: At baseline and week 12
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 15 Dec 2021.
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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.
Elise Duchesne, Ph.D. principal investigator
Université du Québec à Chicoutimi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training program in people with Myotonic Dystrophy 1, run by Élise Duchesne at 1 site in Canada.
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 6 inclusion and 2 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 15 Dec 2021. 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 Canada. 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?
Changes in maximal isometric muscle strength of the knee extensors (time frame: At baseline, week 6, week 12, month 6 and month 9). 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 15 Dec 2021.