Effects of Yoga Practice in Multiple Sclerosis Patients: a Multidimensional Approach
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|ClinicalTrials.gov Identifier: NCT03198598|
Recruitment Status : Active, not recruiting
First Posted : June 26, 2017
Last Update Posted : January 11, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Behavioral: Iyengar Yoga Behavioral: Yoga app||Not Applicable|
Multiple Sclerosis (MS) is one of the most common neurological diseases, which is a cause of disability in young adults. Approximately 60% of the patients will not be able to walk at some point in the disease course. This brings important implications for patients' and family members' quality of life and financial cost to the society. In spite of the clinical significance of MS, its pathophysiology is not completely understood. Many researches have been investigating the role of B and T lymphocytes, the extension of central nervous system lesions and brain activation through neuroimage, separately. A multidimensional approach is necessary for the understanding of MS mechanisms and to verify the effects of therapies, including non-conventional ones, such as yoga. Yoga has been reported as a safe and low coast practice which may be more accessible to MS patients than other types of exercises. In patients with MS there are few well controlled studies, which indicate for example, improvements in fatigue, mobility, gait and humor.
Objectives: To evaluate the effects of yoga practice in MS patients with different EDSS (Expanded Disability Status Scale) scores and healthy controls in aspects such as fatigue, quality of life, movement, cognition, brain activity, self-efficacy, stress, anxiety, depression, affective states and immune response through the analysis of cytokines and B lymphocytes antibody production.
Method: the investigators will apply a multidimensional approach which involves neuropsychological, quality of life and affective aspects evaluation, structural and functional magnetic resonance imaging, near infrared spectroscopy (NIRS) combined with movement analysis (gait, strength, balance etc.), measurements of cytokines and B cells antibody production, comparing MS patients with different scores in the EDSS and healthy controls before and after receiving yoga training delivered by a yoga instructor or through a smartphone application.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Yoga Practice in Multiple Sclerosis Patients: a Multidimensional Approach|
|Actual Study Start Date :||June 19, 2017|
|Estimated Primary Completion Date :||December 26, 2022|
|Estimated Study Completion Date :||December 26, 2022|
Experimental: MS patients with EDSS from 0 to 5.5 for yoga
Three months of Iyengar Yoga practice.
Behavioral: Iyengar Yoga
The patients are going to practice Yoga two times per week during 60 minutes each composed by: 40 minutes of postures, 10 minutes of breathing exercises and 10 minutes of meditation. The proposed Yoga postures will depend on disease severity and will be adapted according to each patient.
|No Intervention: MS patients with EDSS from 0 to 5.5 for control|
Experimental: MS patients with EDSS from 6 to 8 for yoga
Receive a smartphone application that has an eight-week program including meditation practices, Yoga exercises that can be done in a seated or laid position and daily care tips
Behavioral: Yoga app
The patients showing EDSS scores above 6.0 will be divided in two groups of 20. Due to their movements limitations it is not possible to perform a regular Yoga class. In this case they will receive a smartphone application that has an eight-week program including meditation practices, Yoga exercises that can be done in a seated or laid position and daily care tips.
|No Intervention: MS patients with EDSS from 6 to 8 for control|
|No Intervention: Healthy subjects|
- Improvement of overall MS impact in patients life [ Time Frame: 3 months ]Multiple Sclerosis Impact Scale-29 (MSIS-29 - Hobart J et al, 2001);
- Cognition in MS [ Time Frame: 3 months ]Brief International Cognitive Assessment for MS with will evaluate executive function in MS patients
- Fatigue in MS [ Time Frame: 3 months ]Modified Fatigue Impact Scale (MFIS - Pavan et al., 2007)- evaluates the level of fatigue in everyday life.
- Self-efficacy in MS [ Time Frame: 3 months ]MS Self-Efficacy Scale (MSSE - Schwartz et al., 1996)- to evaluate self-efficacy in everyday life
- Cyytokine levels [ Time Frame: 3 months ]The immune system response to the intervention will be evaluated through cytokines levels
- Correlation between gait and hemodynamic response [ Time Frame: 3 months ]The participants will be asked to perform a dual-task inside the gait lab. During the task, we will acquire hemoynamic response from dorso-lateral, SMA, pre-motor and motor cortex using functional near infrared spectroscopy technology (fNIRS). The gait parameters (e.g: step length, joint angles and velocity) recorded will be correlated with the cortical activations taken from the fNIRS.
- Motor agility [ Time Frame: 3 months ]9-hole Peg Test (9-HPT - Grice et al., 2003);
- Awareness and attention [ Time Frame: 3 months ]Mindful attention awareness scale (Brown & Ryan 2003);
- Lymphocyte B activity [ Time Frame: 3 months ]The immune system response to the intervention will be also evaluated through the Lymphocyte B activity
- Walking speed [ Time Frame: 3 months ]Timed 25 foot walk - (National Multiple Sclerosis Society, 2016);
- Ability to stand up and walk [ Time Frame: 3 month3 ]Timed up & go (Podsiadlo & Richardson, 1991);
- Hands strenght [ Time Frame: 3 months ]Hand grip (Godoy, 2005 );
- Self-compassion [ Time Frame: 3 months ]Self-compassion scale (Neff, 2003);
- Affects [ Time Frame: 3 months ]Positive and Negative Affect Schedule (PANAS - Carvalho, 2013);
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|Ages Eligible for Study:||18 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Multiple Sclerosis patients from 18 to 60 years of age, currently in stable immunomodulatory or immunosuppression therapy with no signs of clinical or radiological disease activity for the last 6 months.
- EDSS from 0 to 8
- presents clinical or radiological disease activity for the last 6 months
- no cognitive capacity to understand the written informed consent form
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): NCT03198598
|Hospital Israelita Albert Einstein|
|Sao Paulo, Brazil, 05652901|
|Responsible Party:||Hospital Israelita Albert Einstein|
|Other Study ID Numbers:||
|First Posted:||June 26, 2017 Key Record Dates|
|Last Update Posted:||January 11, 2022|
|Last Verified:||January 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases