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The Utilization of Yoga as a Therapeutic Tool to Promote Physical Activity Behavior Change and Improved Postural Control in Individuals With Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04113135
Recruitment Status : Recruiting
First Posted : October 2, 2019
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
Appalachian State University
Information provided by (Responsible Party):
LaVerene M Garner, Winston Salem State University

Brief Summary:
This randomized control trial will investigate whether using yoga as physical activity improves quality of life, self-efficacy for physical activity, reactive balance, and dual tasking more than education, journaling, and meditation alone in people with Multiple Sclerosis.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Yoga Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Researchers and participants will not be blinded due to the nature of the intervention. Participants will know whether or not they are performing yoga or just receiving the control group intervention. Additionally, the PI is leading the intervention and will therefore know who is in the control vs the experimental. Investigators will attempt to blind clinicians and students completing pre and post intervention testing to who was in the control vs experimental, however, this may not be possible.
Primary Purpose: Treatment
Official Title: The Utilization of Yoga as a Therapeutic Tool to Promote Physical Activity Behavior Change and Improved Postural Control in Individuals With Multiple Sclerosis
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Journaling, meditations, education, yoga intervention Arm
Participants will be required to attend 1x/wk for 7 total sessions. The pre/post testing will take approximately 45 minutes to one hour. Session 1 for all participants will be comprised of an initial screening with a health history questionnaire regarding information about comorbidities, medications, and type of Multiple Sclerosis (MS) diagnosis, and completion of all outcome measurement tests as listed above. Following session one, subjects will be assigned to the control or experimental group utilizing the robust randomization application (RRApp) and the block randomization technique to ensure an equal number of subjects in each group.39 The intervention sessions (2-6) for the experimental group participants consist will include a group discussion of the objectives for the week, 20-30 minutes of education and journaling (Attachment B), 45-60 minutes of PA consisting of various yoga poses followed by SMART goal setting and guided relaxation..
Other: Yoga
Participants will be lead through a series of yoga poses by a licensed physical therapist with advanced training in yoga. Participants in this group will also receive education related to MS as well as SMART goal setting, journaling and guided meditation. Modifications will be offered as needed.

Active Comparator: Journaling, meditation, education arm
Participants will be required to attend 1x/wk for 7 total sessions. The pre/post-testing will take approximately 45 minutes to one hour. Session 1 for all participants (control and experimental) will be comprised of an initial screening with a health history questionnaire regarding information about comorbidities, medications, and type of Multiple Sclerosis (MS) diagnosis, and completion of all outcome measurement tests as listed above. Following session one, subjects will be assigned to the control or experimental group utilizing the robust randomization application (RRApp) and the block randomization technique to ensure an equal number of subjects in each group.39 The control group will participate in a 45-60 minute session for weeks 2-6 consisting of goal setting to facilitate behavior change, education on MS, and meditation. Session 7 will conclude the study with reassessment of all outcome measurements as listed above.
Other: Control
Participants in this group will receive education related to MS as well as SMART goal setting, journaling, and guided meditation.




Primary Outcome Measures :
  1. Mini BESTest (Change is being assessed) [ Time Frame: Pre and post intervention (Week 1 of protocol and week 7 of protocol) ]

    Participants will each complete the Mini Balance Evaluation Systems Test (MiniBEST).

    This assessment is a series of 14 tests measuring anticipatory balance, reactive postural control, sensory orientation, and dynamic gait. 16 The 14 tests will be analyzed together to determine reactive and anticipatory balance, as well as, dual task capabilities. Subjects will be tested with flat-heeled shoes or with shoes and socks off. 16 Each of the 14 items are scored on an ordinal scale from 0-2 with a total of 28 points possible. Higher scores indicate higher levels of function, with 0 indicating the lowest level of function and 2 indicating the highest level of function. Two of the 14 items (Item 3 and Item 6) have right and left assessments in which the lower of the two sides is calculated into the total. If an assistive device is used during an item the score is lowered by one point. If the participant requires physical assistance then the item is automatically scored a 0. 16


  2. 9 hole peg test (Change is being assessed) [ Time Frame: Pre and post intervention (Week 1 of protocol and week 7 of protocol) ]
    Test of fine motor coordination where subjects are asked to use their hands to move 9 pegs from one side of a tray to another. This is a timed outcome.

  3. Timed 25 ft walk (Change is being assessed) [ Time Frame: Pre and post intervention (Week 1 of protocol and week 7 of protocol) ]
    Subjects are asked to walk 25 ft over level surfaces and are timed

  4. Markus Self-Efficacy Scale (Change is being assessed) [ Time Frame: Pre and post intervention (Week 1 of protocol and week 7 of protocol) ]
    The Marcus Self Efficacy Scale is a survey which will be used to measure participants' beliefs about their ability to exercise. 23 This scale consists of five items that resemble barriers to exercise such as planning time, environmental factors, and physical or emotional well-being. 23 For each scenario, participants rate their confidence on an 11-point Likert scale; 0 is 'does not apply to me,' 1 is 'not at all confident' and 11 is 'very confident.' 23 Lower scores indicate lower self-efficacy and suggest less inclination to participate in exercise. According to Marcus et al, this scale scored a test-retest reliability of r=.90 over a two-week period.

  5. Quality of Life Scale (Change is being assessed) [ Time Frame: Pre and post intervention(Week 1 of protocol and week 7 of protocol) ]
    The Quality of Life (QoL) survey consists of 32 items created by Gill et al. 24 This survey allows the participant to evaluate their quality of life based on the biopsychosocial model. The participants are asked to circle a number from 1 'poor' to 5 'excellent' based on their perception of their quality of life. Gill et al 24 recommended the QoL survey as a valuable tool in research based on its psychometric properties. Gill et al 25 re-evaluated the QoL survey for test-retest reliability and compared to other quality of life measurements. Gill et al 24 reported reliability of .793 for ADL and .950 for spirituality. In addition, the QoL survey demonstrated good test-retest reliability ranging from .677 to .816, and intraclass correlations from .676 to .809. 25

  6. Patient Determined Disease Steps (Change is being assessed) [ Time Frame: Pre and post intervention (Week 1 of protocol and week 7 of protocol) ]
    The Patient Determined Disease Steps (PDDS) will be completed by participants in order to determine their level of disability based on their method of ambulation. 26 This outcome measure is based on the Disease Steps scale created by Hohol et al 27 which sought to provide neurologists with a simple guide for therapeutic intervention and to assess patient progress. The PDDS consists of nine ordinal rankings from 0 (normal) to 8 (bedridden). The PDDS has a strong correlation with the Expanded Disability Status Scale (EDSS) which is the most widely accepted measure for MS disability; this confirms criterion validity. 26 According to Learmonth et al 26 the PDDS is a valid and useful patient-reported score system for assessing disability in individuals with MS.

  7. Modified Fatigue Impact Scale (Change is being assessed) [ Time Frame: Pre and post intervention (Week 1 of protocol and week 7 of protocol) ]
    The Modified Fatigue Impact Scale (MFIS) is a self-reported survey which will be used to determine the impact of fatigue on an individual over the last four weeks. 28 This consists of twenty-one items rated on a 5-point Likert scale with 0 being 'never' and 4 being 'almost always'. Scores can be subdivided into physical, psychosocial, and cognitive subscales. Total scores range from 0-84 with higher scores indicating greater fatigue and MS related fatigue is identified as a score of 38 or greater. 28 The minimal clinically important change for the MFIS is 16 points short-term and 20 points long-term. 28 Learmonth et al 28 found the MFIS has an excellent test-retest reliability of 0.837 over a 6-month period. In addition, Amtmann et al 29 found that the MFIS has excellent internal consistency, demonstrated by a Cronbach's alpha greater than 0.93, and known groups validity.

  8. Pittsburgh Sleep Quality Index (Change is being assessed) [ Time Frame: Pre and post intervention (Week 1 of protocol and week 7 of protocol) ]
    The Pittsburgh Sleep Quality Index (PSQI) is a 19 item self-rated questionnaire that will be completed by the participants. The PSQI will serve as a subjective measure of sleep for participants participating in the study, and allow for discrimination between "good" and "poor" sleepers. 30 The 19 individual items assessed help to generate seven component, consisting of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. 30 A global score is obtained from the seven components, ranging from 0-21, with higher scores reflecting poor sleep quality. 31 While the PSQI has not been specifically validated in people diagnosed with MS, it has been used to assess changes in sleep patterns in those diagnosed with MS in many different studies. 30,31

  9. Godin Leisure-Time Physical Activity Questionnaire (Change is being assessed) [ Time Frame: Pre and post intervention (Week 1 of protocol and week 7 of protocol) ]
    The Godin is a 3-question, self-report measure that assesses the frequency that individuals engage in bouts of PA at light, moderate, and strenuous levels. 34 The measure asks frequency of PA at each activity level and uses a formula to calculate a score (MET value) for weekly activity (9 x strenuous, 5 x moderate, and 3 x light). The higher the overall score, the greater the PA level. The MET scores can also be used to classify PA participation into three categories: "active" (24 and higher), "moderately active" (14-23), and "insufficiently active" (less than 14). More recently, research has proposed using only using the moderate and strenuous calculations to classify individuals as "active" (? 24 METS) and insufficiently active" (? 23 METS) to fall in line with PA guidelines in both the United States and Canada. 35-36 It has been used extensively with the MS population. 38

  10. Basic Demographics and Behavioral questionnaire (Change is being assessed) [ Time Frame: Pre and post intervention (Week 1 of protocol and week 7 of protocol) ]
    A basic background questionnaire will be used to gather information on participants age, gender, work history, history with MS, and leisure and physical activity behavior.

  11. Bladder control scale [ Time Frame: Pre and post intervention (Week 1 of protocol and week 7 of protocol) ]
    The Bladder Control Scale (BLCS) is a survey consisting of four items that briefly assess bladder. control and the impact it has on the individual's quality of life. This survey was developed by Turnbull et al (1992) and is cited by the National Multiple Sclerosis user's manual and Beadnall et al. 32 The BLCS has a scoring system ranging from 0-22 with higher scores indicating more difficulty with bladder control. 32, 33 MS specialists were consulted during the development of this scale to ensure content validity. Beadnall et al 32 noted multiple studies showing the BLCS to be valid and having good reliability.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Clinical diagnosis of Multiple Sclerosis.

PDDS Category 0-6. Those patients that are classified as PDDS 5 or 6, must be able to ambulate into the clinic without the use of a wheelchair or scooter.

Ability to participate in light to moderate physical activity for 45 minutes one time per week.

-

Exclusion Criteria:

Participants experiencing a multiple sclerosis exacerbation at the time of the scheduled intervention

Serious Cardiovascular Disease (Uncompensated CHF, Unmanaged hypertension)

Advanced Musculoskeletal Disorder (ie. Unhealed Fracture, advanced stages of osteoporosis)

PDDS Category 7-8

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04113135


Contacts
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Contact: LaVerene M Garner, DPT 336-750-3249 garnerlm@wssu.edu
Contact: Sara Migliarese, PhD 336-750-8968 migliaresesj@wssu.edu

Locations
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United States, North Carolina
Winston Salem State University Recruiting
Winston-Salem, North Carolina, United States, 27110
Contact: LaVerene M Garner, DPT    336-750-3249    garnerlm@wssu.edu   
Contact: Sara J Migiliarese, PhD    336-750-8968      
Sub-Investigator: Sara J Migliarese, PhD         
Sub-Investigator: Kimberly Fasczewski, PhD         
Sponsors and Collaborators
Winston Salem State University
Appalachian State University
Investigators
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Principal Investigator: LaVerene Garner, DPT Winston Salem State University

Publications:
National Multiple Sclerosis Society. Who Gets MS? (Epidemiology). https://www.nationalmssociety.org/What-is-MS/Who-Gets-MS. Accessed June 9, 2019
Gill DL, Chang Y, Murphy KM et al. Quality of Life Assessment for Physical Activity and Health Promotion. Applied Research in Quality of Life. 2011 June; 6(2):181-200
Gill DL, Reifsteck EJ, Adams MM, Shang Y. Quality of Life Assessment for Physical Activity and Health Promotion: Further Psychometrics and Comparison of Measures. Measurement in Physical Education & Exercise Science 2015 Oct;19(4):159-166.
Ritvo P, Fischer J, Miller D, et al. Multiple sclerosis quality of life inventory: a user's manual. National Multiple Sclerosis Society: New York, United States of America, 1997. p. 1-35.
Godin G. The Godin-Shephard Leisure-Time Physical Activity Questionnaire. Health Fit J Cananda. 2011;4(1):18-22.

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Responsible Party: LaVerene M Garner, PT, DPT; Visiting Clinical Assistant Professor;, Winston Salem State University
ClinicalTrials.gov Identifier: NCT04113135    
Other Study ID Numbers: 19-0118
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participants will be de-identified using a number system to ensure the privacy of the individual's health data. Hard copy data will be double-locked in a secure location at Winston Salem State University. Electronic data will be stored on a password protected computer. Data collected will only be accessible to the principal and supplementary investigators. Data will be saved for a minimum of three years. Individuals who will have access to de-identified data will include the principal investigator, co-investigators (Dr Fasczewski and Dr Migliarese), and student physical therapists who are functioning in a graduate assistant role during the study. Additionally, we plan to submit for a clinical trial registry number. No other individuals will have access to individual data.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will become available as collected and will be available through the conclusion of the study (potentially two years)
Access Criteria: CITI training and IRB approval

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases