Pilates+4MS: Pilates Intervention for Multiple Sclerosis

NCT06300619 | Completed

• 1 other identifier: 2022-066
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• Timed 25 Foot Walk

  Participants are instructed to walk 25 feet as fast as they can in the limits of their safety. This is timed.

  Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)

• Timed Up and Go

  Participants begin the test in a seated position. There is a mark on the floor 10 feet from the edge of their seat. When the tester says go, the participant stands from their seat, walks at their normal, comfortable, every-day walking pace to the mark, turns around, walks back to the chair, and sits down again. This is timed.

  Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)

• Berg Balance Scale

  This is a 14-item balance battery involving static and dynamic balance challenges. Each challenge is scored by the tester based on the participants' performance and the total is calculated. The scores range from 0 to 56 with a higher score indicating better functional balance.

  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 (6)

• Triaxial Accelerometer (FitBit) Physical Activity Data (minutes of wear time in sedentary time and light, moderate and vigorous physical activity)

  12 weeks of daily wearing.

• The Godin-Shepherd Leisure Time Exercise Questionnaire

  Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)

• Late-Life Function and Disability Instrument Short Form

  Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)

• Leeds Multiple Sclerosis Quality of Life Scale

  Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)

• Modified Fatigue Impact Scale

  Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)

Study Arms (2)

Pilates

ACTIVE COMPARATOR

Standard Pilates Protocol with no hip/shoulder cuff cuing. Delivered from a seated position.

Behavioral: Pilates

Pilates+4

EXPERIMENTAL

Pilates protocol that involves hip and shoulder cuff activation and stabilization exercises and cues to augment the Pilates exercise.

Behavioral: Pilates+4

Interventions

Pilates+4 BEHAVIORAL

12 weeks of seated Pilates twice weekly. In weeks 1-3, participants receive training on hip and shoulder cuff activation. This occurs through active isometric pressure on the stabilizing limb (not the moving limb during a Pilates movement) for 3 seconds at 30% strength using the participants' own hand (e.g., pressure on the outside of the knee with knee pressing against hand) prior to engaging in each exercise. Following the first 3 weeks, participants in the Pilates+4 group engage in the same Pilates protocol as the comparator group, however, they receive 4-quadrant cues for hip and shoulder cuff activation as they learned in weeks 1-3.

Pilates+4

Pilates BEHAVIORAL

12 weeks of seated Pilates twice weekly. 18 exercises standard in Pilates instruction will be provided with standard Pilates cues (i.e., core activation, cuing the moving limb, breathing synchronization).

Pilates

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Colorado Springs: lead
• University of Illinois at Urbana-Champaign: collaborator

Study Sites (1)

Hybl Sports Medicine and Performance Center

Colorado Springs, Colorado, 80918, United States

Location

Related Publications (24)

• Ensari I, Motl RW, McAuley E. Structural and construct validity of the Leeds Multiple Sclerosis Quality of Life scale. Qual Life Res. 2016 Jun;25(6):1605-11. doi: 10.1007/s11136-015-1202-5. Epub 2015 Dec 11.

  PMID: 26660145 BACKGROUND

• Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010 Jul 16;10:67. doi: 10.1186/1471-2288-10-67.

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• Downs S. The Berg Balance Scale. J Physiother. 2015 Jan;61(1):46. doi: 10.1016/j.jphys.2014.10.002. Epub 2014 Dec 1. No abstract available.

  PMID: 25476663 BACKGROUND

• Cattaneo D, Jonsdottir J, Repetti S. Reliability of four scales on balance disorders in persons with multiple sclerosis. Disabil Rehabil. 2007 Dec 30;29(24):1920-5. doi: 10.1080/09638280701191859. Epub 2007 Apr 26.

  PMID: 17852286 BACKGROUND

• Decavel P, Moulin T, Sagawa Y Jr. Gait tests in multiple sclerosis: Reliability and cut-off values. Gait Posture. 2019 Jan;67:37-42. doi: 10.1016/j.gaitpost.2018.09.020. Epub 2018 Sep 22.

  PMID: 30269001 BACKGROUND

• Donoghue D; Physiotherapy Research and Older People (PROP) group; Stokes EK. How much change is true change? The minimum detectable change of the Berg Balance Scale in elderly people. J Rehabil Med. 2009 Apr;41(5):343-6. doi: 10.2340/16501977-0337.

  PMID: 19363567 BACKGROUND

• Duff WRD, Andrushko JW, Renshaw DW, Chilibeck PD, Farthing JP, Danielson J, Evans CD. Impact of Pilates Exercise in Multiple Sclerosis: A Randomized Controlled Trial. Int J MS Care. 2018 Mar-Apr;20(2):92-100. doi: 10.7224/1537-2073.2017-066.

  PMID: 29670495 BACKGROUND

• Haley SM, Jette AM, Coster WJ, Kooyoomjian JT, Levenson S, Heeren T, Ashba J. Late Life Function and Disability Instrument: II. Development and evaluation of the function component. J Gerontol A Biol Sci Med Sci. 2002 Apr;57(4):M217-22. doi: 10.1093/gerona/57.4.m217.

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• Heesen C, Bohm J, Reich C, Kasper J, Goebel M, Gold SM. Patient perception of bodily functions in multiple sclerosis: gait and visual function are the most valuable. Mult Scler. 2008 Aug;14(7):988-91. doi: 10.1177/1352458508088916. Epub 2008 May 27.

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• Kaufmann M, Salmen A, Barin L, Puhan MA, Calabrese P, Kamm CP, Gobbi C, Kuhle J, Manjaly ZM, Ajdacic-Gross V, Schafroth S, Bottignole B, Ammann S, Zecca C, D'Souza M, von Wyl V; Swiss Multiple Sclerosis Registry (SMSR). Development and validation of the self-reported disability status scale (SRDSS) to estimate EDSS-categories. Mult Scler Relat Disord. 2020 Jul;42:102148. doi: 10.1016/j.msard.2020.102148. Epub 2020 Apr 28.

  PMID: 32371376 BACKGROUND

• Kinnett-Hopkins D, Adamson B, Rougeau K, Motl RW. People with MS are less physically active than healthy controls but as active as those with other chronic diseases: An updated meta-analysis. Mult Scler Relat Disord. 2017 Apr;13:38-43. doi: 10.1016/j.msard.2017.01.016. Epub 2017 Feb 1.

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• Lancaster GA. Pilot and feasibility studies come of age! Pilot Feasibility Stud. 2015;1(1):1. doi: 10.1186/2055-5784-1-1. Epub 2015 Jan 12.

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• Learmonth YC, Dlugonski DD, Pilutti LA, Sandroff BM, Motl RW. The reliability, precision and clinically meaningful change of walking assessments in multiple sclerosis. Mult Scler. 2013 Nov;19(13):1784-91. doi: 10.1177/1352458513483890. Epub 2013 Apr 15.

  PMID: 23587605 BACKGROUND

• Learmonth YC, Paul L, McFadyen AK, Mattison P, Miller L. Reliability and clinical significance of mobility and balance assessments in multiple sclerosis. Int J Rehabil Res. 2012 Mar;35(1):69-74. doi: 10.1097/MRR.0b013e328350b65f.

  PMID: 22315143 BACKGROUND

• Marques KAP, Trindade CBB, Almeida MCV, Bento-Torres NVO. Pilates for rehabilitation in patients with multiple sclerosis: A systematic review of effects on cognition, health-related physical fitness, general symptoms and quality of life. J Bodyw Mov Ther. 2020 Apr;24(2):26-36. doi: 10.1016/j.jbmt.2020.01.008. Epub 2020 Feb 6.

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• Motl RW, Bollaert RE, Sandroff BM. Validation of the Godin Leisure-Time Exercise Questionnaire classification coding system using accelerometry in multiple sclerosis. Rehabil Psychol. 2018 Feb;63(1):77-82. doi: 10.1037/rep0000162. Epub 2017 Jul 31.

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• Motl RW, Cohen JA, Benedict R, Phillips G, LaRocca N, Hudson LD, Rudick R; Multiple Sclerosis Outcome Assessments Consortium. Validity of the timed 25-foot walk as an ambulatory performance outcome measure for multiple sclerosis. Mult Scler. 2017 Apr;23(5):704-710. doi: 10.1177/1352458517690823. Epub 2017 Feb 16.

  PMID: 28206828 BACKGROUND

• Oliver GD, Washington JK, Barfield JW, Gascon SS, Gilmer G. Quantitative Analysis of Proximal and Distal Kinetic Chain Musculature During Dynamic Exercises. J Strength Cond Res. 2018 Jun;32(6):1545-1553. doi: 10.1519/JSC.0000000000002036.

  PMID: 29786622 BACKGROUND

• Paltamaa J, Sarasoja T, Leskinen E, Wikstrom J, Malkia E. Measures of physical functioning predict self-reported performance in self-care, mobility, and domestic life in ambulatory persons with multiple sclerosis. Arch Phys Med Rehabil. 2007 Dec;88(12):1649-57. doi: 10.1016/j.apmr.2007.07.032.

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• Riazi A, Hobart JC, Lamping DL, Fitzpatrick R, Thompson AJ. Multiple Sclerosis Impact Scale (MSIS-29): reliability and validity in hospital based samples. J Neurol Neurosurg Psychiatry. 2002 Dec;73(6):701-4. doi: 10.1136/jnnp.73.6.701.

  PMID: 12438473 BACKGROUND

• Rodriguez-Fuentes G, Silveira-Pereira L, Ferradans-Rodriguez P, Campo-Prieto P. Therapeutic Effects of the Pilates Method in Patients with Multiple Sclerosis: A Systematic Review. J Clin Med. 2022 Jan 28;11(3):683. doi: 10.3390/jcm11030683.

  PMID: 35160134 BACKGROUND

• Sanchez-Lastra MA, Martinez-Aldao D, Molina AJ, Ayan C. Pilates for people with multiple sclerosis: A systematic review and meta-analysis. Mult Scler Relat Disord. 2019 Feb;28:199-212. doi: 10.1016/j.msard.2019.01.006. Epub 2019 Jan 3.

  PMID: 30623859 BACKGROUND

• Sebastiao E, Sandroff BM, Learmonth YC, Motl RW. Validity of the Timed Up and Go Test as a Measure of Functional Mobility in Persons With Multiple Sclerosis. Arch Phys Med Rehabil. 2016 Jul;97(7):1072-7. doi: 10.1016/j.apmr.2015.12.031. Epub 2016 Mar 2.

  PMID: 26944709 BACKGROUND

• van der Linden ML, Bulley C, Geneen LJ, Hooper JE, Cowan P, Mercer TH. Pilates for people with multiple sclerosis who use a wheelchair: feasibility, efficacy and participant experiences. Disabil Rehabil. 2014;36(11):932-9. doi: 10.3109/09638288.2013.824035. Epub 2013 Aug 19.

  PMID: 23957639 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

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

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants know that there are 2 Pilates groups, but not which group is under investigation vs. the comparison group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: March 8, 2024
• Study Start: April 5, 2022
• Primary Completion: August 25, 2022
• Study Completion: August 25, 2022
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)