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

October 31, 2022 updated by: Université du Québec à Chicoutimi

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Jonquière, Quebec, Canada, G7X 4H7
        • Recruiting
        • Groupe de recherche interdisciplinaire Groupe de recherche interdisciplinaire sur les maladies neuromusculaires
        • Contact:
          • Cynthia Gagnon
      • Saguenay, Quebec, Canada, G7H 2B1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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);

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Functional capacity from baseline to week 12
Time Frame: Week 12
Short physical performance battery Functional reach test
Week 12
Change in the Level of physical activity from baseline to week 12
Time Frame: Week 12
Rapid Assessment of physical Activity & International Physical Activity Questionnaires
Week 12
Feasability/acceptability of the program and Satisfaction
Time Frame: Week 12
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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université du Québec à Chicoutimi

Investigators

  • Principal Investigator: Elise Duchesne, Université du Québec à Chicoutimi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

August 10, 2021

First Submitted That Met QC Criteria

October 5, 2021

First Posted (Actual)

October 8, 2021

Study Record Updates

Last Update Posted (Actual)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-791

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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