Clinical trial NCT03198598: Effects of Yoga Practice in Multiple Sclerosis Patients: a Multidimensional Approach
Official title: Effects of Yoga Practice in Multiple Sclerosis Patients: a Multidimensional Approach
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2017-06-26
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Improvement of overall MS impact in patients life
timeFrame: 3 months
measure: Cognition in MS
timeFrame: 3 months
measure: Fatigue in MS
timeFrame: 3 months
measure: Self-efficacy in MS
timeFrame: 3 months
Secondary outcomes:
measure: Cyytokine levels
timeFrame: 3 months
measure: Correlation between gait and hemodynamic response
timeFrame: 3 months
measure: Motor agility
timeFrame: 3 months
measure: Awareness and attention
timeFrame: 3 months
measure: Lymphocyte B activity
timeFrame: 3 months
measure: Walking speed
timeFrame: 3 months
measure: Ability to stand up and walk
timeFrame: 3 month3
measure: Hands strenght
timeFrame: 3 months
measure: Self-compassion
timeFrame: 3 months
measure: Affects
timeFrame: 3 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
Study officials:
References: