The Utilization of Yoga as a Therapeutic Tool to Promote Physical Activity Behavior Change and Improved Postural Control in Individuals With Multiple Sclerosis
NCT ID: NCT04113135
Last Updated: 2020-10-08
Study Results
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Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2020-01-01
2020-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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..
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.
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.
Control
Participants in this group will receive education related to MS as well as SMART goal setting, journaling, and guided meditation.
Interventions
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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.
Control
Participants in this group will receive education related to MS as well as SMART goal setting, journaling, and guided meditation.
Eligibility Criteria
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Inclusion Criteria
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
Serious Cardiovascular Disease (Uncompensated CHF, Unmanaged hypertension)
Advanced Musculoskeletal Disorder (ie. Unhealed Fracture, advanced stages of osteoporosis)
PDDS Category 7-8
\-
18 Years
ALL
No
Sponsors
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Appalachian State University
OTHER
Winston Salem State University
OTHER
Responsible Party
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LaVerene M Garner
PT, DPT; Visiting Clinical Assistant Professor;
Principal Investigators
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LaVerene Garner, DPT
Role: PRINCIPAL_INVESTIGATOR
Winston Salem State University
Locations
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Winston Salem State University
Winston-Salem, North Carolina, United States
Countries
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References
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National Multiple Sclerosis Society. Who Gets MS? (Epidemiology). https://www.nationalmssociety.org/What-is-MS/Who-Gets-MS. Accessed June 9, 2019
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Other Identifiers
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19-0118
Identifier Type: -
Identifier Source: org_study_id
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