Measuring Physical Activity Levels and Intensity Using an ActivPal™ Accelerometer in Adult and Pediatric Populations With Neuromuscular Diseases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Columbia University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Mean Activity Profile (measures time spent at various raw activity levels)
Study Overview
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.
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 Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Year to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Neuromuscular Disease
Patients with confirmed neuromuscular disease
Intervention: ActivPal (Other)
Control
Participants who do not have or are not expected to have neuromuscular disease
Intervention: ActivPal (Other)
Outcomes
Primary Outcomes
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
- Mean intensity Count (measures time spent in various actions such as rest, walking etc.)(Up to 3 years)
Investigators
Michio Hirano, MD
Professor of Neurology
Columbia University