Clinical trial NCT06300619: Pilates+4MS: Pilates Intervention for Multiple Sclerosis
Official title: Evaluating the Impact of Introducing the 4-quadrant Stability Model Into Pilates Instruction: Effects on Function Among Adults With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University of Colorado, Colorado Springs
Sponsor class: OTHER
Collaborators: name: University of Illinois at Urbana-Champaign
First posted: 2024-03-08
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to test the physical health benefits of seated Pilates in the multiple sclerosis (MS) population. The main questions it aims to answer are: 1) is it feasible to deliver a seated Pilates class for 12 weeks, twice weekly over Zoom in a group format among participants with mild, moderate, and severe multiple sclerosis? 2) what are the mobility, balance, and symptom benefits of a 12-week seated Pilates class? 3) Does incorporating hip and shoulder stabilization augment the benefits compared to a standard seated Pilates protocol? 4) Are there benefits to physical activity participation? Participants will be screened over the phone for eligibility criteria and then scheduled for in-person data collection. In person data collection will involve: 1) completing the Timed 25-Foot Walk a total of 4 times, 2) the Timed Up and Go a total of 4 times, 3) the Berg Balance Scale a total of 2 times, and 4) a set of 8 questionnaires about multiple sclerosis symptoms and impact, and physical activity behavior. Participants will receive a FitBit and then will be randomized into the Pilates only group or the Pilates+4-Quadrant stability group for the intervention. The intervention is 12 weeks long, both groups meet twice weekly on Zoom for 60 minutes with 1 of 2 instructors and other class participants (12 per group). They wear the FitBit for all 12 weeks and then return for testing to repeat testing items 1-4 above. Researchers will compare the functional outcomes between the Pilates only group and the Pilates+4-Quadrant Stability group to see if there are differences in mobility, balance and physical activity outcomes.

Detailed description: Twenty-four persons with mild, moderate, and severe MS (PwMS) will be recruited and screened for eligibility criteria. The investigators will actively recruit PwMS through local MS support group events, and previous participant databases. Interested participants will be screened for inclusion/exclusion criteria, i.e. aged 18+, diagnosis of MS, relapse-free in the past 30 days, access to a computer/tablet with internet, willingness to participate in an exercise program, Physical Activity Readiness Questionnaire \<2 affirmatives, between 3 and 5 on Patient Determined Disease Steps (PDDS 3-5). Participants who are qualified will be invited to take part in the study.

The participant involvement includes 4 main components. First, participants will be asked to complete a 90-minute testing session at the Hybl Building on the University of Colorado Colorado Springs (UCCS) campus. This testing session will involve some balance and walking tests (Berg Balance Scale, Timed Up and Go and Timed 25-foot walk) and completion of several questionnaires (Multiple Sclerosis Impact Scale, Late Life Function and Disability Index, Godin Leisure Time Exercise Questionnaire, Leeds Multiple Sclerosis Quality of Life Scale, Modified Fatigue Impact Scales, and Self-Reported Expanded Disability Status Scale). After filling out the questionnaires, participants will repeat the balance and walking tests but with cues mirroring the cues that will be given in the 4-quadrant group (stabilize prior to beginning the movement). Participants will wear an E4 activity monitor (small device worn like a watch) while completing these tasks and investigators will video record the balance and walking tests for later movement analysis.

Upon completion of pre-intervention (T1) tests participants will be randomized into either the Pilates only or the Pilates+ (4-quadrant stability) groups. The participants will be given a manual based on their group assignment with information about using Zoom, class schedule, safety tips, and how-to guides to complete the exercises. The 4-quadrant group will have additional information about functional movement which the other group will only receive upon completion of the intervention. The investigators will also provide participants with a resistance band (TheraBand) and two yoga blocks for them to use while in the study. Participants will be allowed to keep the equipment afterwards. The investigators will instruct participants on the use of a physical activity monitor (FitBit) and help them download an app to allow them to track their physical activity data and send it to the team. The FitBit will be returned upon completion of the study.

The second part of the study involves having the participant wearing the FitBit monitor and sharing their physical activity participation with the team for a period of 12 weeks.

The third part of the study involves participating in a 12-week Pilates program that will be held twice a week for 60 minutes on Zoom. The classes will be seated and taught by trained Pilates instructors with extensive training and knowledge of MS. Aside from the instructor being present, a member of the research team will also always be present to provide technical troubleshooting support, answer questions and watch the participants and alert the instructor of unsafe practices. Participants in the Pilates only class will participate in 24 sessions of Pilates with standard Pilates cues and movements. Participants in the Pilates+ 4 quadrant group will begin with 6 sessions of functional exercise helping them to learn the 4-quadrant stability cues in their bodies (hip and shoulder activation, eye-tracking etc.) Then, this group will transition to the same Pilates protocol as the first group but will continue to receive 4-quadrant cues. In both classes, all exercises will be demonstrated from a seated position.

The fourth part of the study involves returning to UCCS campus for another 90-minute testing session where participants will repeat the balance and walking tests as well as the questionnaires. At the last testing session participants will receive one additional survey - a feedback survey on the program.

All data will be analyzed using Statistical Package for Social Science (SPSS) Statistics 29.0 (Chicago, IL).

Eligibility criteria: Inclusion Criteria:

* aged 18+
* diagnosis of MS (self-reported)
* relapse-free in the past 30 days
* access to a computer/tablet with internet
* willingness to participate in a 12-week exercise program
* Physical Activity Readiness Questionnaire (PARQ) \<2 affirmatives.

Exclusion Criteria:

* aged \<18
* relapse in past 30 days
* PARQ 2+ affirmatives

Primary outcomes:
measure: Timed 25 Foot Walk
timeFrame: Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)
measure: Timed Up and Go
timeFrame: Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)
measure: Berg Balance Scale
timeFrame: Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)
Secondary outcomes:
measure: Triaxial Accelerometer (FitBit) Physical Activity Data (minutes of wear time in sedentary time and light, moderate and vigorous physical activity)
timeFrame: 12 weeks of daily wearing.
measure: The Godin-Shepherd Leisure Time Exercise Questionnaire
timeFrame: Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)
measure: Late-Life Function and Disability Instrument Short Form
timeFrame: Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)
measure: Leeds Multiple Sclerosis Quality of Life Scale
timeFrame: Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)
measure: Modified Fatigue Impact Scale
timeFrame: Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)
measure: Multiple Sclerosis Impact Scale
timeFrame: Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Hybl Sports Medicine and Performance Center
state: Colorado
Study officials:
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