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Myotonic Dystrophy Type 1 (DM1)NCT05072288

A Remote Physical Activity Program in the Population Suffering from Type 1 Myotonic Dystrophy

A study testing Remote activity program in people with Myotonic Dystrophy Type 1 (DM1), run by Université du Québec à Chicoutimi at 2 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The COVID-19 pandemic exacerbates health problems by reducing access to adapted and advanced physical rehabilitation for several people who need rehabilitation services, including the population with myotonic dystrophy type 1 (DM1). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Myotonic Dystrophy Type 1 (DM1)
What is being tested?
Remote activity program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesCanada
Study dates
11 Aug 2021to 1 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • DM1 diagnosis must be confirmed by genetic analysis (juvenile, adults or late-onset phenotypes);
  • Aged between 18 and 60 years old;
  • Be able to do exercise;
  • Subjects must be able to give their consent freely and voluntarily.

Who cannot join

  • Patients who already train (>3 times per week or >150min/week);
  • Don't speak french or english;
  • Are not able to do exercise (even in sitting position);

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Groupe de recherche interdisciplinaire Groupe de recherche interdisciplinaire sur les maladies neuromusculaires

    Jonquière, Quebec, G7X 4H7

  • Université du Québec à Chicoutimi

    Saguenay, Quebec, G7H 2B1

Other trials in Canada

About this study

Official title: A Remote Physical Activity Program Via the PACE Tool to Counter the Physical Impairments, Accentuated by the Pandemic, in the Population Suffering from Type 1 Myotonic Dystrophy

The COVID-19 pandemic exacerbates health problems by reducing access to adapted and advanced physical rehabilitation for several people who need rehabilitation services, including the population with myotonic dystrophy type 1 (DM1). The PACE tool, an innovative web tool integrating pragmatic physical activity programs, seems to be an interesting and innovative intervention to counter physical deficiencies of people with DM1, which are unfortunately accentuated by the pandemic, while reducing the risk of COVID-19 exposure. Objectives: 1) Evaluate the feasibility, usability and acceptability of the PACE tool in the DM1 population; 2) Evaluate the effects of the intervention on their physical and cognitive health; and 3) Estimate the cost-effectiveness ratio of this intervention. Method: Sixty people (experimental group = 40 and control group = 20) will participate in this randomized intervention study. Participants in the experimental group will be assigned to one of the 35 physical activity programs adapted to their condition of the PACE tool. The program must be performed on a daily basis for a period of 12 weeks. Physical and cognitive health will be assessed before and after the remote intervention via ZOOM, for all participants.

Being tested
Remote activity program
Keywords
Myotonic dystrophy type 1, Physical activity, function, balance, mobility
Medical subject headings
Myotonic Dystrophy, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote activity programOther

    Participant will have to do exercise at home everyday (15min/day)

Study groups in NCT05072288
Study groupRoleWhat they receive
Remote activity programExperimentalActivity program based on objective evaluation. Possibility of 35 different programs primarily targeting impairments (lower limb, upper limb or balanced)
Receives: Other: Remote activity program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Functional capacity from baseline to week 12

    Short physical performance battery Functional reach test

    Measured: Week 12

  2. Change in the Level of physical activity from baseline to week 12

    Rapid Assessment of physical Activity \& International Physical Activity Questionnaires

    Measured: Week 12

  3. Feasability/acceptability of the program and Satisfaction

    Number of sessions completed/planned Likert System Usability Scale.

    Measured: Week 12

Secondary outcomes (2)

  1. Changes in the score of the Fatigue and Daytime Sleepiness Scale from baseline to week 12

    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: Week 12

  2. Changes in the Marin apathy scale from baseline to week 12

    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: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2021
  2. Study start11 Aug 2021
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
All participants will receive an adapted remote physical program. Half of the participants will do a 12 weeks control prior to intervention.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05072288
Sponsor's protocol ID
2022-791
Status last verified
Dec 2024
First submitted
10 Aug 2021
Last updated
28 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bouchard G, Roy R, Declos M, Mathieu J, Kouladjian K. Origin and diffusion of the myotonic dystrophy gene in the Saguenay region (Quebec). Can J Neurol Sci. 1989 Feb;16(1):119-22. doi: 10.1017/s0317167100028651.

    PubMed 2924205

  • Mateos-Aierdi AJ, Goicoechea M, Aiastui A, Fernandez-Torron R, Garcia-Puga M, Matheu A, Lopez de Munain A. Muscle wasting in myotonic dystrophies: a model of premature aging. Front Aging Neurosci. 2015 Jul 9;7:125. doi: 10.3389/fnagi.2015.00125. eCollection 2015.

    PubMed 26217220

  • Gagnon C, Petitclerc E, Kierkegaard M, Mathieu J, Duchesne E, Hebert LJ. A 9-year follow-up study of quantitative muscle strength changes in myotonic dystrophy type 1. J Neurol. 2018 Jul;265(7):1698-1705. doi: 10.1007/s00415-018-8898-4. Epub 2018 May 21.

    PubMed 29785524

  • Petitclerc E, Hebert LJ, Mathieu J, Desrosiers J, Gagnon C. Lower limb muscle strength impairment in late-onset and adult myotonic dystrophy type 1 phenotypes. Muscle Nerve. 2017 Jul;56(1):57-63. doi: 10.1002/mus.25451. Epub 2016 Nov 25.

    PubMed 27784130

  • Petitclerc E, Hebert LJ, Mathieu J, Desrosiers J, Gagnon C. Relationships between Lower Limb Muscle Strength Impairments and Physical Limitations in DM1. J Neuromuscul Dis. 2018;5(2):215-224. doi: 10.3233/JND-170291.

    PubMed 29865087

  • Hammaren E, Kjellby-Wendt G, Lindberg C. Muscle force, balance and falls in muscular impaired individuals with myotonic dystrophy type 1: a five-year prospective cohort study. Neuromuscul Disord. 2015 Feb;25(2):141-8. doi: 10.1016/j.nmd.2014.11.004. Epub 2014 Nov 13.

    PubMed 25475393

  • Wiles CM, Busse ME, Sampson CM, Rogers MT, Fenton-May J, van Deursen R. Falls and stumbles in myotonic dystrophy. J Neurol Neurosurg Psychiatry. 2006 Mar;77(3):393-6. doi: 10.1136/jnnp.2005.066258. Epub 2005 Sep 30.

    PubMed 16199443

  • Gallais B, Montreuil M, Gargiulo M, Eymard B, Gagnon C, Laberge L. Prevalence and correlates of apathy in myotonic dystrophy type 1. BMC Neurol. 2015 Aug 22;15:148. doi: 10.1186/s12883-015-0401-6.

    PubMed 26296336

  • Gagnon C, Mathieu J, Jean S, Laberge L, Perron M, Veillette S, Richer L, Noreau L. Predictors of disrupted social participation in myotonic dystrophy type 1. Arch Phys Med Rehabil. 2008 Jul;89(7):1246-55. doi: 10.1016/j.apmr.2007.10.049.

    PubMed 18586127

  • Bertran Recasens B, Rubio MA. Neuromuscular Diseases Care in the Era of COVID-19. Front Neurol. 2020 Nov 26;11:588929. doi: 10.3389/fneur.2020.588929. eCollection 2020.

    PubMed 33329336

  • Di Stefano V, Battaglia G, Giustino V, Gagliardo A, D'Aleo M, Giannini O, Palma A, Brighina F. Significant reduction of physical activity in patients with neuromuscular disease during COVID-19 pandemic: the long-term consequences of quarantine. J Neurol. 2021 Jan;268(1):20-26. doi: 10.1007/s00415-020-10064-6. Epub 2020 Jul 13.

    PubMed 32661716

  • Carvalho LP, Kergoat MJ, Bolduc A, Aubertin-Leheudre M. A Systematic Approach for Prescribing Posthospitalization Home-Based Physical Activity for Mobility in Older Adults: The PATH Study. J Am Med Dir Assoc. 2019 Oct;20(10):1287-1293. doi: 10.1016/j.jamda.2019.01.143. Epub 2019 Mar 11.

    PubMed 30872083

  • Fruteau de Laclos L, Sirois MJ, Blanchette A, Martel D, Blais J, Emond M, Daoust R, Aubertin-Leheudre M. Exercise Interventions for Community-Dwelling Older Adults Following an Emergency Department Consultation for a Minor Injury. J Aging Phys Act. 2021 Apr 1;29(2):267-279. doi: 10.1123/japa.2019-0200. Epub 2020 Oct 27.

    PubMed 33108761

  • Aubertin-Leheudre M, Rolland Y. The Importance of Physical Activity to Care for Frail Older Adults During the COVID-19 Pandemic. J Am Med Dir Assoc. 2020 Jul;21(7):973-976. doi: 10.1016/j.jamda.2020.04.022. Epub 2020 Apr 30. No abstract available.

    PubMed 32513558

  • Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.

    PubMed 19362699

Questions about this trial

What is this clinical trial studying?

A study testing Remote activity program in people with Myotonic Dystrophy Type 1 (DM1), run by Université du Québec à Chicoutimi at 2 sites 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

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 Functional capacity from baseline to week 12 (time frame: Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05072288, which also lists 16 linked publications.

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 Mar 2025.

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