Pilates+4MS: Pilates Intervention for Multiple Sclerosis (P+4MS)

March 7, 2024 updated by: Brynn Adamson, University of Colorado, Colorado Springs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80918
        • Hybl Sports Medicine and Performance Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Active Comparator: Pilates
Standard Pilates Protocol with no hip/shoulder cuff cuing. Delivered from a seated position.
Behavioral: Pilates
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).
Experimental: Pilates+4
Pilates protocol that involves hip and shoulder cuff activation and stabilization exercises and cues to augment the Pilates exercise.
Behavioral: Pilates+4
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Each participant receives a FitBit Inspire device (wearable physical activity monitor worn on the wrist) which measures daily physical activity behavior.
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)
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.
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)
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.
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)
This scale measures subjective quality of life. The scale scores range from 0-24 with higher scores indicating improved quality of life.
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)
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.
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)
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.
Immediately pre intervention (within 2 weeks before the intervention) and immediately post intervention (within 2 weeks following the last date of the intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Colorado Springs

Collaborators

University of Illinois at Urbana-Champaign

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2022

Primary Completion (Actual)

August 25, 2022

Study Completion (Actual)

August 25, 2022

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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