Multiple SclerosisNCT04113135
The Utilization of Yoga as a Therapeutic Tool to Promote Physical Activity Behavior Change and Improved Postural Control in Individuals With Multiple Sclerosis
A study testing Yoga in people with Multiple Sclerosis, run by Winston Salem State University at 1 site in United States.
Trial 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. 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?
- Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 31 Dec 2020
- 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
- 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.
- -
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Winston Salem State University
Winston-Salem, North Carolina, 27110
About this study
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.
Read the detailed description
Multiple sclerosis (MS) is an autoimmune disease characterized by chronic inflammation specifically targeting the central nervous system. 1 It is associated with destruction of the surrounding myelin sheaths leading to formation of plaques/lesions dispersed throughout the brain and spinal cord. 1 The prevalence of MS is nearly one million in the United States with the majority of diagnoses occurring between the ages of 20 and 50. 2 Though the precise etiology remains unknown, genetic and environmental factors have been linked to the cause and therefore MS is considered a multifactorial disease. 3 Hallmark signs of MS include progressive demyelination, oligodendrocyte damage, and ultimately axonal destruction. These adaptations occur due to an inflammatory response consisting of macrophages, microglia, T and B Cells, followed by an intense astrocyte reaction leading to glial scarring, a common characteristic of chronic MS lesions. 4 According to Lassmann 1, clinical deficits seen throughout the course of MS are more closely correlated to the degree of axonal loss as opposed to the amount of lesions or extent of demyelination. These include deficits in cognition, vision, bowel and bladder control, coordination, and loss of muscle strength. 5 Multiple Sclerosis has various subtypes making the clinical course heterogeneous among patients. 6 Subtypes include: clinically isolated syndrome (CIS), relapsing remitting MS (RRMS), primary progressive MS (PPMS), and secondary progressive MS (SPMS). 6 The variability of disease course for each individual subtype is extremely important, and should be taken into consideration for prognosis and intervention options. 3
Due to the aggressive, progressive, unpredictable nature of MS, lack of evidence for a cure, and the wide array of cognitive and physical symptoms, MS can detrimentally impact a patient's health and reduce overall quality of life. 7 Current research advocates for physical activity (PA) as an intervention to combat these effects. Physical activity is referred to here as low to moderate level exercise. 8 Some individuals with MS who incorporated long-term physical activity into their life demonstrated a decrease in the progression of the disease and a reduction in MS flare-ups. 9 In order to successfully implement PA based interventions for the management of MS one must first identify individual motivators for PA. 5 Motivators for physical activity include self-efficacy and internalized motivation which are derived from physical activity outcomes. 5Self-efficacy is "the belief that one can successfully cope with challenging conditions" 7 whereas self -determination refers to the origin of one's motivation. 8 Other researchers found that "those with MS who were more physically active had greater self-efficacy for function and control, and self-efficacy for function and control were associated with greater physical and psychological components of quality of life." 7 However, the vast majority of those diagnosed with MS avoid exerting themselves due to symptoms of muscle weakness and fatigue; this lack of PA is thought to exacerbate those symptoms which then leads to a perpetual cycle of inactivity and flare-ups. 8,9 Therefore, it has also been theorized that a program designed for MS patients which focuses on promoting self-efficacy could lead to long-term PA participation and thus result in increased quality of life. 8
One such form of physical activity that could provide physiological and psychological benefits for individuals diagnosed with MS is yoga. "Yoga is an ancient Indian, non-religious mind- body approach that has components centering on meditation, mindfulness, breathing, and activity or postures." 10 Exercise programs which involve these components have been found to improve the quality of life by addressing the biopsychosocial (BPS) model. The BPS model is composed of biological, psychological and social components which has been found to have a positive impact on an individual's health. 11 Therefore, it is hypothesized that by increasing muscular strength and flexibility while decreasing affective factors such as depression, stress and anxiety and improving social factors will improve an individual's overall well-being and allow them to cope with the symptoms associated with MS. 11,12 Numerous studies have found yoga to be beneficial in improving fatigue and other symptoms associated with MS. 13 For example, standing yoga poses can promote improved reactive balance through the use of stepping strategies. Yoga also has the potential to reduce cognitive and motor costs for individuals during dual tasks resulting in decreased interference and thus optimal functioning in more challenging conditions. 14 Previous research has demonstrated that yoga significantly improved "physical performance and mental function" and factors associated with quality of life in subjects with MS.15 Based on these findings, the investigators hypothesize that yoga will improve quality of life and self-efficacy for physical activity in people living with MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Yoga, Control
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
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.
ControlOther
Participants in this group will receive education related to MS as well as SMART goal setting, journaling, and guided meditation.
| Study group | Role | What they receive |
|---|---|---|
| Journaling, meditations, education, yoga intervention Arm | Experimental | 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.. Receives: Other: Yoga |
| Journaling, meditation, education arm | Active comparator | 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini BESTest (Change is being assessed)
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
Measured: Pre and post intervention (Week 1 of protocol and week 7 of protocol)
9 hole peg test (Change is being assessed)
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.
Measured: Pre and post intervention (Week 1 of protocol and week 7 of protocol)
Timed 25 ft walk (Change is being assessed)
Subjects are asked to walk 25 ft over level surfaces and are timed
Measured: Pre and post intervention (Week 1 of protocol and week 7 of protocol)
Markus Self-Efficacy Scale (Change is being assessed)
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.
Measured: Pre and post intervention (Week 1 of protocol and week 7 of protocol)
Quality of Life Scale (Change is being assessed)
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
Measured: Pre and post intervention(Week 1 of protocol and week 7 of protocol)
Patient Determined Disease Steps (Change is being assessed)
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.
Measured: Pre and post intervention (Week 1 of protocol and week 7 of protocol)
Modified Fatigue Impact Scale (Change is being assessed)
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.
Measured: Pre and post intervention (Week 1 of protocol and week 7 of protocol)
Pittsburgh Sleep Quality Index (Change is being assessed)
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
Measured: Pre and post intervention (Week 1 of protocol and week 7 of protocol)
Godin Leisure-Time Physical Activity Questionnaire (Change is being assessed)
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
Measured: Pre and post intervention (Week 1 of protocol and week 7 of protocol)
Basic Demographics and Behavioral questionnaire (Change is being assessed)
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.
Measured: Pre and post intervention (Week 1 of protocol and week 7 of protocol)
Bladder control scale
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.
Measured: Pre and post intervention (Week 1 of protocol and week 7 of protocol)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start1 Jan 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: Unable to complete initial data collection due to tornado and then COVID-19 has limited in person data collection/intervention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winston Salem State University
- Sponsor type
- University, hospital or other
- Collaborators
- Appalachian State University
- Responsible party
- Principal investigator, LaVerene M Garner, Winston Salem State University
- Investigators
- LaVerene Garner, DPT, Principal investigator, Winston Salem State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113135
- Sponsor's protocol ID
- 19-0118
- Status last verified
- Oct 2020
- First submitted
- 29 Aug 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Lassmann H. Neuropathology in multiple sclerosis: new concepts. Mult Scler. 1998 Jun;4(3):93-8. doi: 10.1177/135245859800400301.
PubMed 9762654National Multiple Sclerosis Society. Who Gets MS? (Epidemiology). https://www.nationalmssociety.org/What-is-MS/Who-Gets-MS. Accessed June 9, 2019
Ghasemi N, Razavi S, Nikzad E. Multiple Sclerosis: Pathogenesis, Symptoms, Diagnoses and Cell-Based Therapy. Cell J. 2017 Apr-Jun;19(1):1-10. doi: 10.22074/cellj.2016.4867. Epub 2016 Dec 21.
PubMed 28367411Bruck W, Lucchinetti C, Lassmann H. The pathology of primary progressive multiple sclerosis. Mult Scler. 2002 Apr;8(2):93-7. doi: 10.1191/1352458502ms785rr.
PubMed 11990878Fasczewski KS, Rothberger SM, Gill DL. Why do they do it? Assessing self-report physical activity behavior and quality of life in individuals with multiple sclerosis. J Health Psychol. 2020 Jun;25(7):964-975. doi: 10.1177/1359105317739965. Epub 2017 Nov 27.
PubMed 29172811Hurwitz BJ. The diagnosis of multiple sclerosis and the clinical subtypes. Ann Indian Acad Neurol. 2009 Oct;12(4):226-30. doi: 10.4103/0972-2327.58276.
PubMed 20182569Motl RW, Snook EM. Physical activity, self-efficacy, and quality of life in multiple sclerosis. Ann Behav Med. 2008 Feb;35(1):111-5. doi: 10.1007/s12160-007-9006-7. Epub 2008 Feb 12.
PubMed 18347911Fasczewski KS, Gill DL. A model of motivation for physical activity in individuals diagnosed with multiple sclerosis. Disabil Rehabil. 2019 Sep;41(18):2143-2150. doi: 10.1080/09638288.2018.1459883. Epub 2018 Apr 10.
PubMed 29631465Fasczewski KS, Gill DL, Rothberger SM. Physical activity motivation and benefits in people with multiple sclerosis. Disabil Rehabil. 2018 Jun;40(13):1517-1523. doi: 10.1080/09638288.2017.1300946. Epub 2017 Mar 14.
PubMed 28291956Wahbeh H, Elsas SM, Oken BS. Mind-body interventions: applications in neurology. Neurology. 2008 Jun 10;70(24):2321-8. doi: 10.1212/01.wnl.0000314667.16386.5e.
PubMed 18541886Bolton RE, Fix GM, VanDeusen Lukas C, Elwy AR, Bokhour BG. Biopsychosocial benefits of movement-based complementary and integrative health therapies for patients with chronic conditions. Chronic Illn. 2020 Mar;16(1):41-54. doi: 10.1177/1742395318782377. Epub 2018 Jun 18. No abstract available.
PubMed 29914264Kahraman T, Ozdogar AT, Yigit P, Hosgel I, Mehdiyev Z, Ertekin O, Ozakbas S. Feasibility of a 6-Month Yoga Program to Improve the Physical and Psychosocial Status of Persons with Multiple Sclerosis and their Family Members. Explore (NY). 2018 Jan-Feb;14(1):36-43. doi: 10.1016/j.explore.2017.07.006. Epub 2017 Oct 23.
PubMed 29174060Rogers KA, MacDonald M. Therapeutic Yoga: Symptom Management for Multiple Sclerosis. J Altern Complement Med. 2015 Nov;21(11):655-9. doi: 10.1089/acm.2015.0015. Epub 2015 Aug 13.
PubMed 26270955Subramaniam S, Bhatt T. Effect of Yoga practice on reducing cognitive-motor interference for improving dynamic balance control in healthy adults. Complement Ther Med. 2017 Feb;30:30-35. doi: 10.1016/j.ctim.2016.10.012. Epub 2016 Oct 26.
PubMed 28137524Cohen ET, Kietrys D, Fogerite SG, Silva M, Logan K, Barone DA, Parrott JS. Feasibility and Impact of an 8-Week Integrative Yoga Program in People with Moderate Multiple Sclerosis-Related Disability: A Pilot Study. Int J MS Care. 2017 Jan-Feb;19(1):30-39. doi: 10.7224/1537-2073.2015-046.
PubMed 28243184
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04113135
- Acronym / sponsor ID
- 19-0118
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to complete initial data collection due to tornado and then COVID-19 has limited in person data collection/intervention.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Winston Salem State UniversityUniversity, hospital or other
- Collaborators
- Appalachian State University
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 2 Oct 2019 (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.
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.
Detailed description
Multiple sclerosis (MS) is an autoimmune disease characterized by chronic inflammation specifically targeting the central nervous system. 1 It is associated with destruction of the surrounding myelin sheaths leading to formation of plaques/lesions dispersed throughout the brain and spinal cord. 1 The prevalence of MS is nearly one million in the United States with the majority of diagnoses occurring between the ages of 20 and 50. 2 Though the precise etiology remains unknown, genetic and environmental factors have been linked to the cause and therefore MS is considered a multifactorial disease. 3 Hallmark signs of MS include progressive demyelination, oligodendrocyte damage, and ultimately axonal destruction. These adaptations occur due to an inflammatory response consisting of macrophages, microglia, T and B Cells, followed by an intense astrocyte reaction leading to glial scarring, a common characteristic of chronic MS lesions. 4 According to Lassmann 1, clinical deficits seen throughout the course of MS are more closely correlated to the degree of axonal loss as opposed to the amount of lesions or extent of demyelination. These include deficits in cognition, vision, bowel and bladder control, coordination, and loss of muscle strength. 5 Multiple Sclerosis has various subtypes making the clinical course heterogeneous among patients. 6 Subtypes include: clinically isolated syndrome (CIS), relapsing remitting MS (RRMS), primary progressive MS (PPMS), and secondary progressive MS (SPMS). 6 The variability of disease course for each individual subtype is extremely important, and should be taken into consideration for prognosis and intervention options. 3
Due to the aggressive, progressive, unpredictable nature of MS, lack of evidence for a cure, and the wide array of cognitive and physical symptoms, MS can detrimentally impact a patient's health and reduce overall quality of life. 7 Current research advocates for physical activity (PA) as an intervention to combat these effects. Physical activity is referred to here as low to moderate level exercise. 8 Some individuals with MS who incorporated long-term physical activity into their life demonstrated a decrease in the progression of the disease and a reduction in MS flare-ups. 9 In order to successfully implement PA based interventions for the management of MS one must first identify individual motivators for PA. 5 Motivators for physical activity include self-efficacy and internalized motivation which are derived from physical activity outcomes. 5Self-efficacy is "the belief that one can successfully cope with challenging conditions" 7 whereas self -determination refers to the origin of one's motivation. 8 Other researchers found that "those with MS who were more physically active had greater self-efficacy for function and control, and self-efficacy for function and control were associated with greater physical and psychological components of quality of life." 7 However, the vast majority of those diagnosed with MS avoid exerting themselves due to symptoms of muscle weakness and fatigue; this lack of PA is thought to exacerbate those symptoms which then leads to a perpetual cycle of inactivity and flare-ups. 8,9 Therefore, it has also been theorized that a program designed for MS patients which focuses on promoting self-efficacy could lead to long-term PA participation and thus result in increased quality of life. 8
One such form of physical activity that could provide physiological and psychological benefits for individuals diagnosed with MS is yoga. "Yoga is an ancient Indian, non-religious mind- body approach that has components centering on meditation, mindfulness, breathing, and activity or postures." 10 Exercise programs which involve these components have been found to improve the quality of life by addressing the biopsychosocial (BPS) model. The BPS model is composed of biological, psychological and social components which has been found to have a positive impact on an individual's health. 11 Therefore, it is hypothesized that by increasing muscular strength and flexibility while decreasing affective factors such as depression, stress and anxiety and improving social factors will improve an individual's overall well-being and allow them to cope with the symptoms associated with MS. 11,12 Numerous studies have found yoga to be beneficial in improving fatigue and other symptoms associated with MS. 13 For example, standing yoga poses can promote improved reactive balance through the use of stepping strategies. Yoga also has the potential to reduce cognitive and motor costs for individuals during dual tasks resulting in decreased interference and thus optimal functioning in more challenging conditions. 14 Previous research has demonstrated that yoga significantly improved "physical performance and mental function" and factors associated with quality of life in subjects with MS.15 Based on these findings, the investigators hypothesize that yoga will improve quality of life and self-efficacy for physical activity in people living with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Journaling, meditations, education, yoga intervention Arm | Experimental | Other: YogaParticipants 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.. |
| Journaling, meditation, education arm | Active comparator | Other: ControlParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- -
Key exclusion criteria (5 listed)
- 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
- -
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 |
|---|---|---|
| YogaParticipants 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. | Other | Journaling, meditations, education, yoga intervention Arm |
| ControlParticipants in this group will receive education related to MS as well as SMART goal setting, journaling, and guided meditation. | Other | Journaling, meditation, education arm |
Primary outcome
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
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.
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
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.
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
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.
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.
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
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
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 9762654Lassmann H. Neuropathology in multiple sclerosis: new concepts. Mult Scler. 1998 Jun;4(3):93-8. doi: 10.1177/135245859800400301.
- BackgroundNational Multiple Sclerosis Society. Who Gets MS? (Epidemiology). https://www.nationalmssociety.org/What-is-MS/Who-Gets-MS. Accessed June 9, 2019
- Background: PubMed 28367411Ghasemi N, Razavi S, Nikzad E. Multiple Sclerosis: Pathogenesis, Symptoms, Diagnoses and Cell-Based Therapy. Cell J. 2017 Apr-Jun;19(1):1-10. doi: 10.22074/cellj.2016.4867. Epub 2016 Dec 21.
- Background: PubMed 11990878Bruck W, Lucchinetti C, Lassmann H. The pathology of primary progressive multiple sclerosis. Mult Scler. 2002 Apr;8(2):93-7. doi: 10.1191/1352458502ms785rr.
- Background: PubMed 29172811Fasczewski KS, Rothberger SM, Gill DL. Why do they do it? Assessing self-report physical activity behavior and quality of life in individuals with multiple sclerosis. J Health Psychol. 2020 Jun;25(7):964-975. doi: 10.1177/1359105317739965. Epub 2017 Nov 27.
- Background: PubMed 20182569Hurwitz BJ. The diagnosis of multiple sclerosis and the clinical subtypes. Ann Indian Acad Neurol. 2009 Oct;12(4):226-30. doi: 10.4103/0972-2327.58276.
- Background: PubMed 18347911Motl RW, Snook EM. Physical activity, self-efficacy, and quality of life in multiple sclerosis. Ann Behav Med. 2008 Feb;35(1):111-5. doi: 10.1007/s12160-007-9006-7. Epub 2008 Feb 12.
- Background: PubMed 29631465Fasczewski KS, Gill DL. A model of motivation for physical activity in individuals diagnosed with multiple sclerosis. Disabil Rehabil. 2019 Sep;41(18):2143-2150. doi: 10.1080/09638288.2018.1459883. Epub 2018 Apr 10.
- Background: PubMed 28291956Fasczewski KS, Gill DL, Rothberger SM. Physical activity motivation and benefits in people with multiple sclerosis. Disabil Rehabil. 2018 Jun;40(13):1517-1523. doi: 10.1080/09638288.2017.1300946. Epub 2017 Mar 14.
- Background: PubMed 18541886Wahbeh H, Elsas SM, Oken BS. Mind-body interventions: applications in neurology. Neurology. 2008 Jun 10;70(24):2321-8. doi: 10.1212/01.wnl.0000314667.16386.5e.
- Background: PubMed 29914264Bolton RE, Fix GM, VanDeusen Lukas C, Elwy AR, Bokhour BG. Biopsychosocial benefits of movement-based complementary and integrative health therapies for patients with chronic conditions. Chronic Illn. 2020 Mar;16(1):41-54. doi: 10.1177/1742395318782377. Epub 2018 Jun 18. No abstract available.
- Background: PubMed 29174060Kahraman T, Ozdogar AT, Yigit P, Hosgel I, Mehdiyev Z, Ertekin O, Ozakbas S. Feasibility of a 6-Month Yoga Program to Improve the Physical and Psychosocial Status of Persons with Multiple Sclerosis and their Family Members. Explore (NY). 2018 Jan-Feb;14(1):36-43. doi: 10.1016/j.explore.2017.07.006. Epub 2017 Oct 23.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
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.
LaVerene Garner, DPT principal investigator
Winston Salem State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Multiple Sclerosis, run by Winston Salem State University 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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 8 Oct 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
Mini BESTest (Change is being assessed) (time frame: Pre and post intervention (Week 1 of protocol and week 7 of protocol)). The study lists 11 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 NCT04113135, which also lists 39 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 Oct 2020; AzTrials last refreshed its copy on 8 Nov 2026.