- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07504120
The Effect of Remotely Delivered Pilates on Physical , and Psychological Outcomes in Individuals With Multiple Sclerosis (MS)
Does Remotely Delivered Pilates Influence Physical and Psychological Outcomes in Individuals With Multiple Sclerosis?
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Pilates group
Behavioral: Pilates group
|
REMOTLY PILATES EXERCISE
|
|
No Intervention: Control group
Waitlist Group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in walking endurance (Six-Minute Walk Test distance)
Time Frame: 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.
|
Baseline and 16 weeks (end of treatment)
|
|
Change from baseline in walking speed (Timed 25-Foot Walk)
Time Frame: 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.
|
Baseline and 16 weeks (end of treatment)
|
|
Change from baseline in balance (Berg Balance Scale)
Time Frame: 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.
|
Baseline and 16 weeks (end of treatment)
|
|
Change from baseline in fatigue (Fatigue Severity Scale)
Time Frame: 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.
|
Baseline and 16 weeks (end of treatment)
|
|
Change from baseline in pain (Short-form McGill Pain Questionnaire)
Time Frame: 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.
|
Baseline and 16 weeks (end of treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in cognitive processing speed (Symbol Digit Modalities Test)
Time Frame: 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.
|
Baseline and 16 weeks (end of treatment)
|
|
Change from baseline in verbal learning and memory (California Verbal Learning Test-II)
Time Frame: 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.
|
Baseline and 16 weeks (end of treatment)
|
|
Change from baseline in visuospatial learning and memory (Brief Visuospatial Memory Test-Revised)
Time Frame: 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.
|
Baseline and 16 weeks (end of treatment)
|
|
Change from baseline in depression symptoms
Time Frame: 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.
|
Baseline and 16 weeks (end of treatment)
|
|
Change from baseline in anxiety symptoms
Time Frame: 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.
|
Baseline and 16 weeks (end of treatment)
|
|
Change from baseline in health-related quality of life
Time Frame: 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.
|
Baseline and 16 weeks (end of treatment)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Autoimmune Diseases
- Immune System Diseases
- Behavioral Symptoms
- Neurobehavioral Manifestations
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Pain
- Multiple Sclerosis
- Depression
- Fatigue
- Agnosia
- Therapeutics
- Physical Therapy Modalities
- Exercise Movement Techniques
Other Study ID Numbers
- STUDY2025-0648-MOD001
- MB-2110-38597 (Other Grant/Funding Number: National Multiple Sclerosis Society)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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