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

Study Overview
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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.

Official Title
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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

Conditions
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Myotonic Dystrophy Type 1 (DM1)

Intervention / Treatment
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* Other: Remote activity program


Participation Criteria
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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);

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote activity program<br>Activity program based on objective evaluation. Possibility of 35 different programs primarily targeting impairments (lower limb, upper limb or balanced) | Other: Remote activity program<br>* Participant will have to do exercise at home everyday (15min/day)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myotonic dystrophy type 1, Physical activity, function, balance, mobility