Multiple SclerosisP+4MSNCT06300619
Pilates+4MS: Pilates Intervention for Multiple Sclerosis
A study testing Pilates+4 and Pilates in people with Multiple Sclerosis, run by University of Colorado, Colorado Springs at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Pilates+4 and Pilates
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2022to 25 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- aged <18
- relapse in past 30 days
- PARQ 2+ affirmatives
Trial locations and contacts
1 site in 1 country.
United States1 site
Hybl Sports Medicine and Performance Center
Colorado Springs, Colorado, 80918
About this study
Official title: Evaluating the Impact of Introducing the 4-quadrant Stability Model Into Pilates Instruction: Effects on Function Among Adults With Multiple Sclerosis
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.
Read the 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).
- Conditions
- Multiple Sclerosis
- Being tested
- Pilates+4, Pilates
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates+4Behavioural
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.
PilatesBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Pilates | Active comparator | Standard Pilates Protocol with no hip/shoulder cuff cuing. Delivered from a seated position. Receives: Behavioral: Pilates |
| Pilates+4 | Experimental | Pilates protocol that involves hip and shoulder cuff activation and stabilization exercises and cues to augment the Pilates exercise. Receives: Behavioral: Pilates+4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
Each participant receives a FitBit Inspire device (wearable physical activity monitor worn on the wrist) which measures daily physical activity behavior.
Measured: 12 weeks of daily wearing.
The Godin-Shepherd Leisure Time Exercise Questionnaire
This is a survey of 4 items asking about light, moderate, and high intensity exercise behavior as well as one question on how many times per week the participant is active enough to sweat. The values range from 0 to 119 with higher scores equating to increased physical activity participation.
Measured: 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
This survey is a measure of function and disability/impairment. The scale scoring ranges from 0-100 with higher scores indicating increased function and lower impact of disability on daily activity.
Measured: 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
This scale measures subjective quality of life. The scale scores range from 0-24 with higher scores indicating improved quality of life.
Measured: 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
This scale measures the perceptions that fatigue impacts various aspects of the participants activities of daily living and participation. The scores range from 0-36 with higher scores indicating worse fatigue impact.
Measured: Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)
Multiple Sclerosis Impact Scale
This scale measures the subjective perception of how MS impacts various aspects of the participants activities of daily living and participation across physical and psychological components. This scale has two subscales (physical and psychological). Scores on the physical impact scale can range from 20 to 80 and on the psychological impact scale from 9 to 36, with lower scores indicating little impact of MS and higher scores indicating greater impact.
Measured: Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start5 Apr 2022
- Primary completion25 Aug 2022
- Study completion25 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Colorado Springs
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign
- Responsible party
- Principal investigator, Brynn Adamson, University of Colorado, Colorado Springs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300619
- Sponsor's protocol ID
- 2022-066
- Acronym
- P+4MS
- Status last verified
- Mar 2024
- First submitted
- 12 Jan 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26660145Arain 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.
PubMed 20637084Downs 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.
PubMed 25476663Cattaneo 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.
PubMed 17852286Decavel 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.
PubMed 30269001Donoghue 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.
PubMed 19363567Duff 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.
PubMed 29670495Haley 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.
PubMed 11909886Heesen 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.
PubMed 18505775Kaufmann 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.
PubMed 32371376Kinnett-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.
PubMed 28427699Lancaster 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.
PubMed 29611687Learmonth 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.
PubMed 23587605Learmonth 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.
PubMed 22315143Marques 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.
PubMed 32507148
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Introducing the 4-quadrant Stability Model Into Pilates Instruction: Effects on Function Among Adults With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06300619
- Acronym / sponsor ID
- P+4MS / 2022-066
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Colorado, Colorado SpringsUniversity, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates | Active comparator | Behavioral: PilatesStandard Pilates Protocol with no hip/shoulder cuff cuing. Delivered from a seated position. |
| Pilates+4 | Experimental | Behavioral: Pilates+4Pilates protocol that involves hip and shoulder cuff activation and stabilization exercises and cues to augment the Pilates exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- aged <18
- relapse in past 30 days
- PARQ 2+ affirmatives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates+412 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. | Behavioural | Pilates+4 |
| Pilates12 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). | Behavioural | Pilates |
Primary outcome
Timed 25 Foot Walk
Time frame: Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)
Participants are instructed to walk 25 feet as fast as they can in the limits of their safety. This is timed.
Timed Up and Go
Time frame: Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)
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.
Berg Balance Scale
Time frame: Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)
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.
6 secondary outcomes
Triaxial Accelerometer (FitBit) Physical Activity Data (minutes of wear time in sedentary time and light, moderate and vigorous physical activity)
Time frame: 12 weeks of daily wearing.
The Godin-Shepherd Leisure Time Exercise Questionnaire
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)
Multiple Sclerosis Impact Scale
Time frame: Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Background: PubMed 26660145Ensari 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.
- Background: PubMed 20637084Arain 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.
- Background: PubMed 25476663Downs 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.
- Background: PubMed 17852286Cattaneo 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.
- Background: PubMed 30269001Decavel 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.
- Background: PubMed 19363567Donoghue 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.
- Background: PubMed 29670495Duff 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.
- Background: PubMed 11909886Haley 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.
- Background: PubMed 18505775Heesen 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.
- Background: PubMed 32371376Kaufmann 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.
- Background: PubMed 28427699Kinnett-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.
- Background: PubMed 29611687Lancaster 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates+4 and Pilates in people with Multiple Sclerosis, run by University of Colorado, Colorado Springs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed 25 Foot Walk (time frame: Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06300619, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.