The Effect of Remotely Delivered Pilates on Physical , and Psychological Outcomes in Individuals With Multiple Sclerosis

NCT07504120 | Not Yet Recruiting

• 2 other identifiers: STUDY2025-0648-MOD001MB-2110-38597
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Walking; Balance; Fatigue in Multiple Sclerosis; Pain Management; Multiple Sclerosis; Pilates Exercise; Quality of Life; Depression; Cognition; Fatigue

Keywords

multiple sclerosis; Pilates; Fatigue; Cognition; Quality of life; Walking; Depression; Balance; Pain

Outcome Measures

Primary Outcomes (5)

• 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)

Secondary Outcomes (6)

• Change from baseline in cognitive processing speed (Symbol Digit Modalities Test)

  Baseline and 16 weeks (end of treatment)

• Change from baseline in verbal learning and memory (California Verbal Learning Test-II)

  Baseline and 16 weeks (end of treatment)

• Change from baseline in visuospatial learning and memory (Brief Visuospatial Memory Test-Revised)

  Baseline and 16 weeks (end of treatment)

• Change from baseline in depression symptoms

  Baseline and 16 weeks (end of treatment)

• Change from baseline in anxiety symptoms

  Baseline and 16 weeks (end of treatment)

Study Arms (2)

Pilates group

OTHER

Behavioral: Pilates group

Behavioral: Pilates

Control group

NO INTERVENTION

Waitlist Group

Interventions

Pilates BEHAVIORAL

REMOTLY PILATES EXERCISE

Pilates group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

MeSH Terms

Conditions

Multiple Sclerosis; Agnosia; Depression; Fatigue; Pain

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: March 31, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2025-08