Multiple Sclerosis Clinical Trial
Official title:
Lifestyle Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis
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 (i.e., 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 (i.e., 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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | April 22, 2025 |
Est. primary completion date | April 22, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - aged 18 years or older - self-reported diagnosis of MS by a neurologist within the past 2 years - relapse-free for the past 30 days - ability to speak and read English as primary language - internet and e-mail access, and willingness to complete the testing and questionnaires - ambulatory without an assistive device (e.g., cane) - insufficiently active (Godin Leisure-Time Exercise Questionnaire (GLTEQ) < 14) - visual ability and literacy to read newsletter with font size 14 points - on a disease-modifying therapy. Exclusion Criteria: - pregnant - have elevated risk for undertaking strenuous or maximal exercise based on two or more affirmatives on the Physical Activity Readiness Questionnaire (PAR-Q) |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physical Activity Behavior | Godin Leisure-Time Exercise Questionnaire (GLTEQ); scores range between 0 (min) and 119 (max), higher scores indicate greater engagement in physical activity behavior. | Changes in the GLTEQ scores from Baseline (pre-intervention) and after 16 weeks (post-intervention) | |
Primary | Physical Activity Behavior | International Physical Activity Questionnaire (IPAQ); scores range between 0 (min) and 107 (max), higher scores indicate greater engagement in physical activity behavior. | Changes in the IPAQ scores from Baseline (pre-intervention) and after 16 weeks (post-intervention) | |
Primary | Physical Activity Level (Light physical activity) | Time (minutes/day) spent in light physical activity (LPA) will be measured by a waist-worn accelerometer (ActiGraph model GT3X+); participants will wear the accelerometer on a belt around their waist during the waking hours of a 7 day period; a longer time of LPA reflects a higher level of physical activity. | Changes in time spent in LPA from Baseline (pre-intervention) and after 16 weeks (post-intervention) | |
Primary | Physical Activity Level (Moderate-to-vigorous physical activity) | Time (minutes/day) spent in moderate-to-vigorous physical activity (MVPA) will be measured by a waist-worn accelerometer (ActiGraph model GT3X+); participants will wear the accelerometer on a belt around their waist during the waking hours of a 7 day period; a longer time of MVPA reflects a higher level of physical activity. | Changes in time spent in MVPA from Baseline (pre-intervention) and after 16 weeks (post-intervention) | |
Primary | Physical Activity Level (Daily step count) | Daily step count will be measured by a waist-worn accelerometer (ActiGraph model GT3X+); participants will wear the accelerometer on a belt around their waist during the waking hours of a 7 day period; a greater number of steps per day reflects a higher level of physical activity. | Changes in time spent in daily step count from Baseline (pre-intervention) and after 16 weeks (post-intervention) | |
Secondary | Health-related quality of Life | Short Form Health Status Survey (SF-12); scores range between 0 (min) and 100 (max), higher scores indicate better physical and mental aspects of quality of life. | Changes in SF-12 scores from Baseline (pre-intervention) and after 16 weeks (post-intervention) | |
Secondary | Health-related Quality of Life | Multiple Sclerosis Impact Scale (MSIS-29); scores range between 0 (min) and 100 (max), higher scores indicate greater impact of disease on daily function (i.e. worse outcomes). | Changes in MSIS-29 scores from Baseline (pre-intervention) and after 16 weeks (post-intervention) | |
Secondary | Fatigue Severity | Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity. | Changes in fatigue severity scores from Baseline (pre-intervention) and after 16 weeks (post-intervention) | |
Secondary | Depressive Symptoms | Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms. | Changes in depressive symptoms scores from Baseline (pre-intervention) and after 16 weeks (post-intervention) | |
Secondary | Anxiety | Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms. | Changes in anxiety scores from Baseline (pre-intervention) and after 16 weeks (post-intervention) |
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