Effects of Yoga Practice in Multiple Sclerosis Patients: a Multidimensional Approach

• ClinicalTrials.gov Identifier: NCT03198598
• Recruitment Status: Active, not recruiting
• First Posted: June 26, 2017
• Last Update Posted: September 25, 2020
• Sponsor: Hospital Israelita Albert Einstein
• Information provided by (Responsible Party): Hospital Israelita Albert Einstein

Study Description

Brief Summary:

In this study the investigators will evaluate the effects of yoga practice on multiple sclerosis patients and healthy controls for fatigue, quality of life, movement, cognition, brain activity, self-efficacy, stress, anxiety, depression, affective states and immunological response. To investigate the effects of yoga training delivered by a yoga instructor or through a smartphone application, the investigators will use a multidimensional approach that comprises of: evaluation of neuropsychological, quality of life and affective aspects, structural and functional magnetic resonance imaging, functional near infrared spectroscopy (fNIRS) combined with movement analysis (gait, strength, balance etc.) and analysis of the immune response.

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis	Behavioral: Iyengar Yoga; Behavioral: Yoga app	Not Applicable

Detailed Description:

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 130 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Effects of Yoga Practice in Multiple Sclerosis Patients: a Multidimensional Approach
• Actual Study Start Date: June 19, 2017
• Estimated Primary Completion Date: May 26, 2021
• Estimated Study Completion Date: June 26, 2021

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Improvement of overall MS impact in patients life [ Time Frame: 3 months ]
   Multiple Sclerosis Impact Scale-29 (MSIS-29 - Hobart J et al, 2001);
2. Cognition in MS [ Time Frame: 3 months ]
   Brief International Cognitive Assessment for MS with will evaluate executive function in MS patients
3. Fatigue in MS [ Time Frame: 3 months ]
   Modified Fatigue Impact Scale (MFIS - Pavan et al., 2007)- evaluates the level of fatigue in everyday life.
4. Self-efficacy in MS [ Time Frame: 3 months ]
   MS Self-Efficacy Scale (MSSE - Schwartz et al., 1996)- to evaluate self-efficacy in everyday life

Secondary Outcome Measures :

1. Cyytokine levels [ Time Frame: 3 months ]
   The immune system response to the intervention will be evaluated through cytokines levels
2. 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.
3. Motor agility [ Time Frame: 3 months ]
   9-hole Peg Test (9-HPT - Grice et al., 2003);
4. Awareness and attention [ Time Frame: 3 months ]
   Mindful attention awareness scale (Brown & Ryan 2003);
5. Lymphocyte B activity [ Time Frame: 3 months ]
   The immune system response to the intervention will be also evaluated through the Lymphocyte B activity
6. Walking speed [ Time Frame: 3 months ]
   Timed 25 foot walk - (National Multiple Sclerosis Society, 2016);
7. Ability to stand up and walk [ Time Frame: 3 month3 ]
   Timed up & go (Podsiadlo & Richardson, 1991);
8. Hands strenght [ Time Frame: 3 months ]
   Hand grip (Godoy, 2005 );
9. Self-compassion [ Time Frame: 3 months ]
   Self-compassion scale (Neff, 2003);
10. Affects [ Time Frame: 3 months ]
    Positive and Negative Affect Schedule (PANAS - Carvalho, 2013);

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• presents clinical or radiological disease activity for the last 6 months
• no cognitive capacity to understand the written informed consent form

Contacts and Locations

Locations

Brazil

Hospital Israelita Albert Einstein

Sao Paulo, Brazil, 05652901

Sponsors and Collaborators

Hospital Israelita Albert Einstein

More Information

• Responsible Party: Hospital Israelita Albert Einstein
• ClinicalTrials.gov Identifier: NCT03198598
• Other Study ID Numbers: HIAE_EscleroseMultipla_Yoga
• First Posted: June 26, 2017
• Last Update Posted: September 25, 2020
• Last Verified: May 2020

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

Additional relevant MeSH terms:

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