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

Myotonic Dystrophy Type 1 (DM1) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05072288
• Other study ID #: 2022-791
• Status: Recruiting
• Phase: N/A
• Start date: August 11, 2021
• Est. completion date: January 1, 2024

Study information

• Verified date: October 2022
• Source: Université du Québec à Chicoutimi
• Contact: Anne-Marie Fortin
• Phone: 418-590-0993
• Email: anne-marie3_fortin[@]uqac.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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);

Related Conditions & MeSH terms

• Myotonic Dystrophy
• Myotonic Dystrophy Type 1 (DM1)

Intervention

Other:
• Remote activity program
Participant will have to do exercise at home everyday (15min/day)

Locations

Country	Name	City	State
Canada	Groupe de recherche interdisciplinaire Groupe de recherche interdisciplinaire sur les maladies neuromusculaires	Jonquière	Quebec
Canada	Université du Québec à Chicoutimi	Saguenay	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université du Québec à Chicoutimi

Country where clinical trial is conducted

Canada, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Fruteau de Laclos L, Sirois MJ, Blanchette A, Martel D, Blais J, Émond 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. — View Citation

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. — View Citation

Gagnon C, Petitclerc É, Kierkegaard M, Mathieu J, Duchesne É, Hébert 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. — View Citation

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. — View Citation

Hammarén 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. — View Citation

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. — View Citation

Mateos-Aierdi AJ, Goicoechea M, Aiastui A, Fernández-Torrón R, Garcia-Puga M, Matheu A, López 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. Review. — View Citation

Petitclerc É, Hébert 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. — View Citation

Petitclerc É, Hébert 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. — View Citation

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. Epub 2005 Sep 30. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Functional capacity from baseline to week 12	Short physical performance battery Functional reach test	Week 12
Primary	Change in the Level of physical activity from baseline to week 12	Rapid Assessment of physical Activity & International Physical Activity Questionnaires	Week 12
Primary	Feasability/acceptability of the program and Satisfaction	Number of sessions completed/planned Likert System Usability Scale.	Week 12
Secondary	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.	Week 12
Secondary	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.	Week 12