Measuring Physical Activity With ActivPal

Neuromuscular Diseases Clinical Trial

— Activpal  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06084026
• Other study ID #: AAAS6805
• Secondary ID: R01AG062401U54NS
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: Columbia University
• Contact: Michio Hirano, MD
• Phone: 1-212-305-1319
• Email: mh29[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Observational

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Diseases

Intervention

Other:
• ActivPal
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.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	6 minute walk test (6MWT)	Participant walks in hallway for 6 minutes as fast as possible (no running).	Up to 3 years
Primary	Mean Activity Profile (measures time spent at various raw activity levels)	Activity level established with Activpal meter-button like device work on thigh.	Up to 3 years
Secondary	Mean intensity Count (measures time spent in various actions such as rest, walking etc.)	Fatigue level established with Activpal meter--button like device worn on thigh.	Up to 3 years