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NCT Number: NCT06084026

Measuring Physical Activity With ActivPal

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. Participants will also have a physical exam, six minute walk test,vital signs and questionnaires.

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Key information

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

Location status: Recruiting

Location contact

Kris Engelstad, MS

CONTACT

[email protected]

1-212-342-5767

Michio Hirano, MD

PRINCIPAL_INVESTIGATOR

About this study

Routine physical activity can be an important indicator of health across an individual's life span. Nonetheless, the frequency of inactivity continues to be problematic for a large number of children and adolescents. Adding to that challenge, fatigue has been described as a typical symptom of neurological diseases and disorders Consumer wearables and accelerometers are becoming increasingly popular to track physical activities and monitor health and disease progression. With the increased adoption of activity trackers comes the increased generation of valuable individual-based data. Generated data has the potential to provide detailed insights into the user's behavior and lifestyle. Although methods for objectively measuring physical activity in children and adults in naturalistic settings are well established (i.e., accelerometry), they are most widely used on healthy individuals. Due to cost and technical requirements, these technologies are limited which effects their wide-scale use. Ultimately, this undermines efforts to evaluate physical activity changes and nuances among healthy and diseased populations. This is of particular interest in rare disease populations, specifically in neuromuscular diseases, where one can study a wide range of features that can be used to monitor an individual's sleep, vertical positioning, or overall physical activity. Tracking physical activity can help provide clinicians with a more accurate disease profile and help to identify possible interventions. Collection of this data could potentially provide valuable insight into an individual's daily routines, lifestyle, and behaviors.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

ActivPal

Other

Participants will wear the activity meter (a small button like device) on their thigh for a period of 7 days at the following time-points: baseline, 6, 12, 18, 24, 30 and 36 months. The meter will be placed on their thigh at a research visit and mailed back to the study team after 7 days.

Primary outcomes

  1. Mean Activity Profile (measures time spent at various raw activity levels)

    Time frame: Up to 3 years

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

Secondary outcomes

  1. Mean intensity Count (measures time spent in various actions such as rest, walking etc.)

    Time frame: Up to 3 years

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

Other outcomes

  1. 6 minute walk test (6MWT)

    Time frame: Up to 3 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Kris Engelstad, MS

CONTACT

[email protected]

1-212-342-5767

Michio Hirano, MD

CONTACT

[email protected]

1-212-305-1319

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)
  • National Institute on Aging (NIA)

Registry information

Official study title

Measuring Physical Activity Levels and Intensity Using an ActivPal™ Accelerometer in Adult and Pediatric Populations With Neuromuscular Diseases

Acronym: Activpal

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 16, 2023
Registry last updated
Jan 23, 2026

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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