Clinical trial NCT06084026: Measuring Physical Activity With ActivPal
Official title: Measuring Physical Activity Levels and Intensity Using an ActivPal™ Accelerometer in Adult and Pediatric Populations With Neuromuscular Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuromuscular Diseases
Keywords: muscle weakness
muscle
neuromuscular
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2023-10-16
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Activity Profile (measures time spent at various raw activity levels)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Mean intensity Count (measures time spent in various actions such as rest, walking etc.)
timeFrame: Up to 3 years
Other outcomes:
measure: 6 minute walk test (6MWT)
timeFrame: Up to 3 years
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Michio Hirano, MD
role: PRINCIPAL_INVESTIGATOR
References: