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

NCT ID: NCT05072288

Last Updated: 2025-03-28

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-11

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Myotonic Dystrophy Type 1 (DM1)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will receive an adapted remote physical program. Half of the participants will do a 12 weeks control prior to intervention.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Remote activity program

Activity program based on objective evaluation. Possibility of 35 different programs primarily targeting impairments (lower limb, upper limb or balanced)

Group Type EXPERIMENTAL

Remote activity program

Intervention Type OTHER

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

Interventions

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Remote activity program

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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);
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université du Québec à Chicoutimi

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elise Duchesne

Role: PRINCIPAL_INVESTIGATOR

Université du Québec à Chicoutimi

Locations

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

Jonquière, Quebec, Canada

Site Status

Université du Québec à Chicoutimi

Saguenay, Quebec, Canada

Site Status

Countries

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Canada

References

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Reference Type BACKGROUND
PMID: 2924205 (View on PubMed)

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Reference Type BACKGROUND
PMID: 26217220 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29785524 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27784130 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29865087 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 16199443 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26296336 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18586127 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33329336 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32661716 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30872083 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33108761 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32513558 (View on PubMed)

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.

Reference Type BACKGROUND
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Hilgers RD, Roes K, Stallard N; IDeAl, Asterix and InSPiRe project groups. Directions for new developments on statistical design and analysis of small population group trials. Orphanet J Rare Dis. 2016 Jun 14;11(1):78. doi: 10.1186/s13023-016-0464-5.

Reference Type BACKGROUND
PMID: 27301273 (View on PubMed)

Other Identifiers

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2022-791

Identifier Type: -

Identifier Source: org_study_id

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