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Activpal: Measuring Physical Activity With ActivPal

Sponsor
Columbia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06084026
Collaborator
(none)
40
Enrollment
1
Location
120
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study measures the level of physical activity in participants with neuromuscular disorders. The patient wears a small button like meter on their leg for a period of 1 week every 6 months over a period of 3 years. Participant will also have a physical exam, six minute walk test,vital signs and questionnaires.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Primary objective: To measure sitting, lying, standing, and activity levels using the ActivPAL accelerometer in persons with a diagnosed neuromuscular disease compared to healthy controls.

    Secondary objective: The rate of fatigue as well as possible abnormal sleeping patterns between those with a diagnosed neuromuscular disease and healthy controls.

    This study measures the level of physical activity in participants with neuromuscular disorders. The participant wears a small button like meter on their leg for a period of 1 week every 6 months for 3 years. Participant will also have a physical exam, six minute walk test,vital signs and questionnaires.

    Participants who cannot come to the research site participation in all of these procedures, may participate in just the wearing of the physical activity meter and complete questionnaires from home.

    Statistical analysis will include all useable data.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Measuring Physical Activity Levels and Intensity Using an ActivPal™ Accelerometer in Adult and Pediatric Populations With Neuromuscular Diseases
    Actual Study Start Date :
    Jul 10, 2020
    Anticipated Primary Completion Date :
    Jan 10, 2030
    Anticipated Study Completion Date :
    Jul 10, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    Neuromuscular Disease

    Patients with confirmed neuromuscular disease
    Control

    Participants who do not have or are not expected to have neuromuscular disease

    Outcome Measures

    Primary Outcome Measures

    1. Mean Activity Level in sitting, lying and standing [1 week bi-yearly for 3 years]

      Activity level established with Activpal meter-button like device work on thigh

    Secondary Outcome Measures

    1. Rate of fatigue [1 week bi-yearly for 3 years]

      Fatigue level established with Activpal meter--button like device worn on thigh

    Other Outcome Measures

    1. 6 minute walk test [6 minutes bi yearly for 3 years]

      Participant walks in hallway for 6 minutes as fast as possible (no running)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Patients with a clinically or genetically confirmed neuromuscular disorder

    • Control subjects who do not have a neuromuscular disease.

    • Participants at least 1 years of age.

    Exclusion Criteria:

    • Participant has a condition, which in the opinion of the Investigator may compromise safety

    • Participant has a condition, which in the opinion of the Investigator may compromise or compliance

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Columbia University Irving Medical Center New York New York United States 10032

    Sponsors and Collaborators

    • Columbia University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michio Hirano, MD, Professor of Neurology, Columbia University
    ClinicalTrials.gov Identifier:
    NCT06084026
    Other Study ID Numbers:
    • AAAS6805
    First Posted:
    Oct 16, 2023
    Last Update Posted:
    Oct 16, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Michio Hirano, MD, Professor of Neurology, Columbia University
    muscle weakness
    muscle
    neuromuscular
    Additional relevant MeSH terms:
    Neuromuscular Diseases

    Study Results

    No Results Posted as of Oct 16, 2023