Clinical trial NCT05072288: A Remote Physical Activity Program in the Population Suffering from Type 1 Myotonic Dystrophy
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myotonic Dystrophy Type 1 (DM1)
Keywords: Myotonic dystrophy type 1
Physical activity
function
balance
mobility
Lead sponsor: Université du Québec à Chicoutimi
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive an adapted remote physical program. Half of the participants will do a 12 weeks control prior to intervention.
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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);

Primary outcomes:
measure: Change in Functional capacity from baseline to week 12
timeFrame: Week 12
measure: Change in the Level of physical activity from baseline to week 12
timeFrame: Week 12
measure: Feasability/acceptability of the program and Satisfaction
timeFrame: Week 12
Secondary outcomes:
measure: Changes in the score of the Fatigue and Daytime Sleepiness Scale from baseline to week 12
timeFrame: Week 12
measure: Changes in the Marin apathy scale from baseline to week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Jonquière
country: Canada
facility: Groupe de recherche interdisciplinaire Groupe de recherche interdisciplinaire sur les maladies neuromusculaires
state: Quebec
city: Saguenay
country: Canada
facility: Université du Québec à Chicoutimi
state: Quebec
Study officials:
affiliation: Université du Québec à Chicoutimi
name: Elise Duchesne
role: PRINCIPAL_INVESTIGATOR
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