Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT03198598 |
Other study ID # |
HIAE_EscleroseMultipla_Yoga |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 19, 2017 |
Est. completion date |
December 26, 2026 |
Study information
Verified date |
February 2024 |
Source |
Hospital Israelita Albert Einstein |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.