Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06355804
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-03-27
Brief Title:
Lifestyle Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
Lifestyle Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall objective of the current study is to determine the efficacy of a 16-week remotely delivered lifestyle behavioral intervention compared with a control condition ie waitlist control in persons newly diagnosed with MS disease duration 2 years
Specific Aim 1 To evaluate the changes in self-report and device-measured physical activity after the 16-week remotely delivered physical activity behavior change intervention compared with a control condition ie waitlist control in persons who have diagnosed with MS within the past two years The investigators hypothesize that the 16-week behavior change intervention will yield greater improvements in physical activity levels than the control condition immediately after the intervention
Specific Aim 2 To investigate the efficacy of the 16-week remotely delivered physical activity behavior change intervention compared with the control condition for improvements in fatigue depression anxiety and QoL in persons newly diagnosed with MS The investigators hypothesize that there will be beneficial effects on the symptoms and QoL outcomes immediately after the physical activity intervention compared with minimal changes in the control condition
Specific Aim 1 To evaluate the changes in self-report and device-measured physical activity after the 16-week remotely delivered physical activity behavior change intervention compared with a control condition ie waitlist control in persons who have diagnosed with MS within the past two years The investigators hypothesize that the 16-week behavior change intervention will yield greater improvements in physical activity levels than the control condition immediately after the intervention
Specific Aim 2 To investigate the efficacy of the 16-week remotely delivered physical activity behavior change intervention compared with the control condition for improvements in fatigue depression anxiety and QoL in persons newly diagnosed with MS The investigators hypothesize that there will be beneficial effects on the symptoms and QoL outcomes immediately after the physical activity intervention compared with minimal changes in the control condition
Detailed Description:
Multiple sclerosis MS is a prevalent neurological disease of the central nervous system that is the leading cause of neurological disability among young adults in the United States This disease results in the progressive loss of walking substantial worsening of cognition symptoms of fatigue as well as compromised quality of life QoL There is evidence that physical activity is beneficially associated with walking mobility cognitive function symptoms of fatigue depression anxiety and pain in persons with MS Nonetheless this population is strikingly sedentary and physically inactive including persons newly diagnosed with MS diagnosed with MS for two years or less Indeed approximately 40 of persons with MS reported stopping physical activity after an MS diagnosis and persons recently diagnosed with MS have not been included in physical activity intervention research Yet the early stage of MS represents an ideal time point for initiating physical activity for life-long benefits There is further evidence that physical activity and exercises interventions delivered remotely can yield benefits in managing MS symptoms and comorbidities and disability progression To this end the objective of this current study is to examine the efficacy of a 16-week remotely delivered behavioral intervention compared with a control condition ie waitlist control for increasing physical activity and improving secondary outcomes in persons newly diagnosed with MS disease duration 2 years Participants will complete a series of assessments of physical activity MS symptoms and physical and cognitive function before and immediately after the 16-week program The assessments involve the completion of a battery of questionnaires remotely over the Internet The investigators will also ask that participants wear an accelerometer like a pedometer during the waking hours of the day for a 7-day period as an assessment of physical activity The first assessments occur upon enrollment in the study Baseline Assessment and the second occurs right after the intervention 16- week Assessment In this study participants will be randomly assigned into 1 of 2 conditions a physical activity condition receive the intervention immediately after baseline assessment or a waitlist condition receive the intervention after the 16-week assessment Participants in both conditions will receive access to an Internet delivered program for 16 weeks as well as one-on-one coaching through Zoom The investigators will ask that participants in the physical activity condition wear a Fitbit this is different from the accelerometer for tracking physical activity daily during the 16- week period The investigators will further ask that information from the Fitbit be recorded into a logbook daily
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None