Measuring Physical Activity With ActivPal

NCT06084026 | Recruiting

• 3 other identifiers: AAAS6805R01AG062401U54NS078059
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Neuromuscular Diseases

Keywords

muscle weakness; muscle; neuromuscular

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Up to 3 years

Other Outcomes (1)

• 6 minute walk test (6MWT)

  Up to 3 years

Study Arms (2)

Neuromuscular Disease

Patients with confirmed neuromuscular disease

Other: ActivPal

Control

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

Other: ActivPal

Interventions

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.

Control; Neuromuscular Disease

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Aging (NIA): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Neuromuscular Diseases; Muscle Weakness

Condition Hierarchy (Ancestors)

Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Michio Hirano, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michio Hirano, MD

CONTACT

1-212-305-1319; mh29@cumc.columbia.edu

Kris Engelstad, MS

CONTACT

1-212-342-5767; ke4@cumc.columbia.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 16, 2023
• Study Start: November 1, 2020
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)