Measuring Physical Activity With ActivPal

(Activpal Trial)

Overseen By Kris Engelstad, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Safety, compliance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Michio Hirano, MD

Principal Investigator

Columbia University

Eligibility Criteria

Inclusion Criteria

You are at least 1 year in age.

You are free from any neuromuscular affliction.

You have been clinically or genetically diagnosed with a neuromuscular disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo a physical exam, six minute walk test, vital signs assessment, and complete questionnaires

1 week

1 visit (in-person)

Monitoring

Participants wear an ActivPal™ accelerometer for 1 week every 6 months to measure physical activity levels and intensity

3 years

Biannual visits (in-person)

Follow-up

Participants are monitored for changes in physical activity and health status

4 weeks

Treatment Details

Participant Groups

Group I: Neuromuscular Disease Experimental Treatment 1 Intervention

Patients with confirmed neuromuscular disease

Group II: Control Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+