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| ID | Type | Description | Link |
|---|---|---|---|
| MB-2110-38597 | Other Grant/Funding Number | National Multiple Sclerosis Society |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilates group | Other | Behavioral: Pilates group |
|
| Control group | No Intervention | Waitlist Group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pilates | Behavioral | REMOTLY PILATES EXERCISE |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in walking endurance (Six-Minute Walk Test distance) | 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. | Baseline and 16 weeks (end of treatment) |
| Change from baseline in walking speed (Timed 25-Foot Walk) | 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. | Baseline and 16 weeks (end of treatment) |
| Change from baseline in balance (Berg Balance Scale) | 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. | Baseline and 16 weeks (end of treatment) |
| Change from baseline in fatigue (Fatigue Severity Scale) | 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. | Baseline and 16 weeks (end of treatment) |
| Change from baseline in pain (Short-form McGill Pain Questionnaire) | 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. | Baseline and 16 weeks (end of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in cognitive processing speed (Symbol Digit Modalities Test) | 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. | Baseline and 16 weeks (end of treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Change from baseline in verbal learning and memory (California Verbal Learning Test-II) | 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. | Baseline and 16 weeks (end of treatment) |
| Change from baseline in visuospatial learning and memory (Brief Visuospatial Memory Test-Revised) | 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. | Baseline and 16 weeks (end of treatment) |
| Change from baseline in depression symptoms | 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. | Baseline and 16 weeks (end of treatment) |
| Change from baseline in anxiety symptoms | 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. | Baseline and 16 weeks (end of treatment) |
| Change from baseline in health-related quality of life | 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. | Baseline and 16 weeks (end of treatment) |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D000377 | Agnosia |
| D003863 | Depression |
| D005221 | Fatigue |
| D010146 | Pain |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D026241 | Exercise Movement Techniques |
| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
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