Measuring Physical Activity With ActivPal (Activpal)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neuromuscular Diseases
• Intervention / Treatment: Other: ActivPal

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Michio Hirano, MD; Phone Number: 1-212-305-1319; Email: mh29@cumc.columbia.edu
• Study Contact Backup: Name: Kris Engelstad, MS; Phone Number: 1-212-342-5767; Email: ke4@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center
      • Principal Investigator: Michio Hirano, MD
      • Contact: Kris Engelstad, MS; Phone Number: 1-212-342-5767; Email: ke4@cumc.columbia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients with clinically or geneticallly confirmed neuromuscular disorder or controls who do not have, or are not expected to have neuromuscular disease.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neuromuscular Disease; Patients with confirmed neuromuscular disease	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.
Control; Participants who do not have or are not expected to have neuromuscular disease	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minute walk test (6MWT)	Participant walks in hallway for 6 minutes as fast as possible (no running).	Up to 3 years

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); National Institute on Aging (NIA)
• Investigators: Principal Investigator: Michio Hirano, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: muscle weakness; neuromuscular; muscle
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Weakness; Neuromuscular Diseases
• Other Study ID Numbers: AAAS6805; U54NS078059 (U.S. NIH Grant/Contract); R01AG062401 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No