MedPath

Measuring Physical Activity With ActivPal

Recruiting
Conditions
Neuromuscular Diseases
Interventions
Other: ActivPal
Registration Number
NCT06084026
Lead Sponsor
Columbia University
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
40
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Neuromuscular DiseaseActivPalPatients with confirmed neuromuscular disease
ControlActivPalParticipants who do not have or are not expected to have neuromuscular disease
Primary Outcome Measures
NameTimeMethod
Mean Activity Profile (measures time spent at various raw activity levels)Up to 3 years

Activity level established with Activpal meter-button like device work on thigh.

Secondary Outcome Measures
NameTimeMethod
Mean intensity Count (measures time spent in various actions such as rest, walking etc.)Up to 3 years

Fatigue level established with Activpal meter--button like device worn on thigh.

Trial Locations

Locations (1)

Columbia University Irving Medical Center

🇺🇸

New York, New York, United States

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