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Active, Not Recruiting

NCT Number: NCT05072288

A Remote Physical Activity Program 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Myotonic Dystrophy Type 1 (DM1) Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Motor Activity Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Musculoskeletal Diseases Myotonic Disorders Myotonic Dystrophy Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe de recherche interdisciplinaire Groupe de recherche interdisciplinaire sur les maladies neuromusculaires, Jonquière, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

Remote activity program

Other

Participant will have to do exercise at home everyday (15min/day)

Primary outcomes

  1. Change in Functional capacity from baseline to week 12

    Time frame: Week 12

    Short physical performance battery Functional reach test

  2. 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

  3. Feasability/acceptability of the program and Satisfaction

    Time frame: Week 12

    Number of sessions completed/planned Likert System Usability Scale.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Université du Québec à Chicoutimi

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Oct 8, 2021
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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