Back to resultsA Remote Physical Activity Program in the Population Suffering From Type 1 Myotonic Dystrophy
Primary Purpose
Myotonic Dystrophy Type 1 (DM1)
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Remote activity program
Sponsored by
About this trial
This is an interventional prevention trial for Myotonic Dystrophy Type 1 (DM1) focused on measuring Myotonic dystrophy type 1, Physical activity, function, balance, mobility
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);
Sites / Locations
- Groupe de recherche interdisciplinaire Groupe de recherche interdisciplinaire sur les maladies neuromusculairesRecruiting
- Université du Québec à ChicoutimiRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Remote activity program
Arm Description
Activity program based on objective evaluation. Possibility of 35 different programs primarily targeting impairments (lower limb, upper limb or balanced)
Outcomes
Primary Outcome Measures
Change in Functional capacity from baseline to week 12
Short physical performance battery Functional reach test
Change in the Level of physical activity from baseline to week 12
Rapid Assessment of physical Activity & International Physical Activity Questionnaires
Feasability/acceptability of the program and Satisfaction
Number of sessions completed/planned Likert System Usability Scale.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05072288
First Posted
August 10, 2021
Last Updated
October 31, 2022
Sponsor
Université du Québec à Chicoutimi
1. Study Identification
Unique Protocol Identification Number
NCT05072288
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université du Québec à Chicoutimi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myotonic Dystrophy Type 1 (DM1)
Keywords
Myotonic dystrophy type 1, Physical activity, function, balance, mobility
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Remote activity program
Arm Type
Experimental
Arm Description
Activity program based on objective evaluation. Possibility of 35 different programs primarily targeting impairments (lower limb, upper limb or balanced)
Intervention Type
Other
Intervention Name(s)
Remote activity program
Intervention Description
Participant will have to do exercise at home everyday (15min/day)
Primary Outcome Measure Information:
Title
Change in Functional capacity from baseline to week 12
Description
Short physical performance battery Functional reach test
Time Frame
Week 12
Title
Change in the Level of physical activity from baseline to week 12
Description
Rapid Assessment of physical Activity & International Physical Activity Questionnaires
Time Frame
Week 12
Title
Feasability/acceptability of the program and Satisfaction
Description
Number of sessions completed/planned Likert System Usability Scale.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Changes in the score of the Fatigue and Daytime Sleepiness Scale from baseline to week 12
Description
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.
Time Frame
Week 12
Title
Changes in the Marin apathy scale from baseline to week 12
Description
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.
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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);
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Marie Fortin
Phone
418-590-0993
Email
anne-marie3_fortin@uqac.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Elise Duchesne
Phone
418-590-3552
Email
elise1_duchesne@uqac.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elise Duchesne
Organizational Affiliation
Université du Québec à Chicoutimi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe de recherche interdisciplinaire Groupe de recherche interdisciplinaire sur les maladies neuromusculaires
City
Jonquière
State/Province
Quebec
ZIP/Postal Code
G7X 4H7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Gagnon
Facility Name
Université du Québec à Chicoutimi
City
Saguenay
State/Province
Quebec
ZIP/Postal Code
G7H 2B1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Marie Fortin
Phone
418-590-0993
Email
anne-marie3_fortin@uqac.ca
First Name & Middle Initial & Last Name & Degree
Elise Duchesne
Phone
418-590-3552
Email
elise1_duchesne@uqac.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
2924205
Citation
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PubMed Identifier
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Results Reference
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A Remote Physical Activity Program in the Population Suffering From Type 1 Myotonic Dystrophy
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