Measuring Physical Activity With ActivPal
ConditionNeuromuscular Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorColumbia University
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Patients with clinically or geneticallly confirmed neuromuscular disorder or controls who do not have, or are not expected to have neuromuscular disease.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
ActivPal
Other interventionParticipants 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Neuromuscular Disease1 intervention
Group B: Control1 intervention
Trial outcomes
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.
Time frame
Up to 3 yearsSecondary outcomes
1
Mean intensity Count (measures time spent in various actions such as rest, walking etc.)
Fatigue level established with Activpal meter--button like device worn on thigh.
Time frame
Up to 3 yearsOther outcomes
1
6 minute walk test (6MWT)
Participant walks in hallway for 6 minutes as fast as possible (no running).
Time frame
Up to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov