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

NCT05072288 | Active Not Recruiting

• 1 other identifier: 2022-791
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Myotonic Dystrophy Type 1 (DM1)

Keywords

Myotonic dystrophy type 1; Physical activity; function; balance; mobility

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Changes in the score of the Fatigue and Daytime Sleepiness Scale from baseline to week 12

  Week 12

• Changes in the Marin apathy scale from baseline to week 12

  Week 12

Study Arms (1)

Remote activity program

EXPERIMENTAL

Activity program based on objective evaluation. Possibility of 35 different programs primarily targeting impairments (lower limb, upper limb or balanced)

Other: Remote activity program

Interventions

Remote activity program OTHER

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

Remote activity program

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Université du Québec à Chicoutimi: lead

Study Sites (2)

Groupe de recherche interdisciplinaire Groupe de recherche interdisciplinaire sur les maladies neuromusculaires

Jonquière, Quebec, G7X 4H7, Canada

Location

Université du Québec à Chicoutimi

Saguenay, Quebec, G7H 2B1, Canada

Location

Related Publications (16)

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MeSH Terms

Conditions

Myotonic Dystrophy; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Myotonic Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Study Officials

• Elise Duchesne

  Université du Québec à Chicoutimi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive an adapted remote physical program. Half of the participants will do a 12 weeks control prior to intervention.

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: October 8, 2021
• Study Start: August 11, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 28, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)