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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03198598
• Other study ID #: HIAE_EscleroseMultipla_Yoga
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: December 26, 2026
• Est. primary completion date: December 26, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of overall MS impact in patients life	Multiple Sclerosis Impact Scale-29 (MSIS-29 - Hobart J et al, 2001);	3 months
Primary	Cognition in MS	Brief International Cognitive Assessment for MS with will evaluate executive function in MS patients	3 months
Primary	Fatigue in MS	Modified Fatigue Impact Scale (MFIS - Pavan et al., 2007)- evaluates the level of fatigue in everyday life.	3 months
Primary	Self-efficacy in MS	MS Self-Efficacy Scale (MSSE - Schwartz et al., 1996)- to evaluate self-efficacy in everyday life	3 months
Secondary	Cyytokine levels	The immune system response to the intervention will be evaluated through cytokines levels	3 months
Secondary	Correlation between gait and hemodynamic response	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 months
Secondary	Motor agility	9-hole Peg Test (9-HPT - Grice et al., 2003);	3 months
Secondary	Awareness and attention	Mindful attention awareness scale (Brown & Ryan 2003);	3 months
Secondary	Lymphocyte B activity	The immune system response to the intervention will be also evaluated through the Lymphocyte B activity	3 months
Secondary	Walking speed	Timed 25 foot walk - (National Multiple Sclerosis Society, 2016);	3 months
Secondary	Ability to stand up and walk	Timed up & go (Podsiadlo & Richardson, 1991);	3 month3
Secondary	Hands strenght	Hand grip (Godoy, 2005 );	3 months
Secondary	Self-compassion	Self-compassion scale (Neff, 2003);	3 months
Secondary	Affects	Positive and Negative Affect Schedule (PANAS - Carvalho, 2013);	3 months