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NCT Number: NCT03198598

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Israelita Albert Einstein

São Paulo, 05652901, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iyengar Yoga

Behavioral

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.

Yoga app

Behavioral

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.

Primary outcomes

  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 outcomes

  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);

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Registry information

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2017
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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