Balance, Cognition, Depression, Fatigue, Fatigue in Multiple Sclerosis, Multiple Sclerosis, Pain Management, Pilates Exercise, Quality of Life, Walking
Conditions
Keywords
multiple sclerosis, Pilates, Fatigue, Cognition, Quality of life, Walking, Depression, Balance, Pain
Brief summary
Objectives Objective 1: To determine the effects of a 16-week remotely delivered Pilates intervention on walking endurance, walking speed, balance, fatigue, and pain compared to a waitlist control group in individuals with MS. Objective 2: To examine the impact of a 16-week remotely delivered Pilates intervention on depression & anxiety, cognitive function, and QOL compared to a waitlist control group in individuals with MS. Aim Aim 1: To assess whether the 16-week remotely delivered Pilates intervention significantly improves walking endurance, walking speed, balance, fatigue, and pain compared to a waitlist control group in individuals with MS Aim 2: To investigate whether the 16-week remotely delivered Pilates intervention significantly improves depression & anxiety, cognitive function, and QOL compared to a waitlist control group in individuals with MS. Hypothesis Hypothesis 1: The 16-week remotely delivered Pilates intervention will significantly improve walking endurance, walking speed, balance, fatigue, and pain compared to a waitlist control group in individuals with MS. Hypothesis 2: Participants receiving the 16-week remotely delivered Pilates intervention will demonstrate significantly greater improvements in depression & anxiety, cognitive function, and QOL compared to a waitlist control group in individuals with MS.
Detailed description
The current study will determine the feasibility and efficacy of a 16-week remotely delivered Pilates intervention for improving physical and psychological outcomes, and QOL, compared with a control condition, in individuals with MS. This represents a significant step forward in examining Pilates as an accessible, complementary therapy in MS.
Interventions
BEHAVIORALPilates
REMOTLY PILATES EXERCISE
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Intervention model description
our participants will be randomly assigned to either the Pilates intervention group or the waitlist control group, and both groups proceed simultaneously-this is a parallel design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Self-reported diagnosis of multiple sclerosis by a neurologist * Relapse-free for the past 30 days before screening * Able to speak and read English as the primary language * Access to the internet and e-mail, * Ability to use Zoom, and willingness to complete testing sessions and questionnaires * Ambulatory without an assistive device (for example, cane) * Low to moderate disability, defined as a score of 0-4 on the Patient-Determined Disease Steps (PDDS) * Insufficiently active, defined as a score \< 14 on the Godin Leisure-Time Exercise Questionnaire-Health Contribution Score (GLTEQ-HCS) * Adequate visual ability and literacy to read materials printed in 14-point font * Currently treated with a disease-modifying therapy
Exclusion criteria
* Pregnant * Elevated risk for strenuous or maximal exercise, defined as more than one "Yes" response on the Physical Activity Readiness Questionnaire (PAR-Q) during screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in walking endurance (Six-Minute Walk Test distance) | Baseline and 16 weeks (end of treatment) | Distance walked during the Six-Minute Walk Test (6MWT) will be measured in meters. The outcome is the change from baseline to 16 weeks in 6MWT distance. |
| Change from baseline in walking speed (Timed 25-Foot Walk) | Baseline and 16 weeks (end of treatment) | Walking speed will be assessed using the Timed 25-Foot Walk (T25FW). The outcome is the change from baseline to 16 weeks in time to walk 25 feet, measured in seconds. |
| Change from baseline in balance (Berg Balance Scale) | Baseline and 16 weeks (end of treatment) | Balance will be assessed using the Berg Balance Scale (BBS), a 14-item performance-based measure of static and dynamic balance. Each item is scored from 0 to 4, and the outcome will be the change from baseline to 16 weeks in the BBS total score (range 0-56), with higher scores indicating better balance and lower risk of falls. |
| Change from baseline in fatigue (Fatigue Severity Scale) | Baseline and 16 weeks (end of treatment) | Fatigue will be measured using the Fatigue Severity Scale (FSS), a 9-item questionnaire assessing the impact of fatigue on daily functioning. Each item is rated from 1 to 7, and the outcome will be the change from baseline to 16 weeks in the FSS mean score (range 1-7), with higher scores indicating more severe fatigue. |
| Change from baseline in pain (Short-form McGill Pain Questionnaire) | Baseline and 16 weeks (end of treatment) | Pain will be measured using the Short-form McGill Pain Questionnaire (SF-MPQ). The outcome is the change from baseline to 16 weeks in SF-MPQ total score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in cognitive processing speed (Symbol Digit Modalities Test) | Baseline and 16 weeks (end of treatment) | Cognitive processing speed will be assessed using the Symbol Digit Modalities Test (SDMT). The outcome is the change from baseline to 16 weeks in SDMT total score, with higher scores indicating better processing speed. SDMT scores typically range from 0 to about 110 correct responses. |
| Change from baseline in verbal learning and memory (California Verbal Learning Test-II) | Baseline and 16 weeks (end of treatment) | Verbal learning and memory will be assessed using the California Verbal Learning Test-II (CVLT-II). The outcome is the change from baseline to 16 weeks in CVLT-II total recall score, with higher scores indicating better verbal learning and memory. CVLT-II total recall scores typically range from 0 to about 80. |
| Change from baseline in visuospatial learning and memory (Brief Visuospatial Memory Test-Revised) | Baseline and 16 weeks (end of treatment) | Visuospatial learning and memory will be assessed using the Brief Visuospatial Memory Test-Revised (BVMT-R). The outcome is the change from baseline to 16 weeks in BVMT-R total recall score, with higher scores indicating better visuospatial memory. BVMT-R total recall scores typically range from 0 to 36. |
| Change from baseline in depression symptoms | Baseline and 16 weeks (end of treatment) | Depression will be measured using a validated questionnaire (e.g., the Hospital Anxiety and Depression Scale-Depression subscale or a similar instrument). The outcome is the change from baseline to 16 weeks in depression total score, with higher scores indicating greater depressive symptoms. Typical depression scales have ranges such as 0-21 (HADS-D) ; enter the exact range that matches the scale you are using. |
| Change from baseline in anxiety symptoms | Baseline and 16 weeks (end of treatment) | Anxiety will be measured using a validated questionnaire (e.g., the Hospital Anxiety and Depression Scale-Anxiety subscale or a similar instrument). The outcome is the change from baseline to 16 weeks in anxiety total score, with higher scores indicating greater anxiety. Typical anxiety scales have ranges such as 0-21 (HADS-A) or 0-63 (BAI); enter the exact range that matches the scale you are using. |
| Change from baseline in health-related quality of life | Baseline and 16 weeks (end of treatment) | Health-related quality of life will be assessed using a validated questionnaire (e.g., the MSQoL-54 or a comparable instrument). The outcome is the change from baseline to 16 weeks in the quality-of-life total score or composite score. For instruments scored 0-100, higher scores typically indicate better quality of life; specify the exact scoring range and direction according to your chosen measure. |
Outcome results
None listed