Effects of Yoga Practice in Multiple Sclerosis Patients: a Multidimensional Approach
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Self-efficacy in MS
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
MS patients with EDSS from 6 to 8 for control
Healthy subjects
MS patients with EDSS from 0 to 5.5 for yoga
Three months of Iyengar Yoga practice.
Intervention: Iyengar Yoga (Behavioral)
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
Intervention: Yoga app (Behavioral)
MS patients with EDSS from 0 to 5.5 for control
Outcomes
Primary Outcomes
Self-efficacy in MS
Time Frame: 3 months
MS Self-Efficacy Scale (MSSE - Schwartz et al., 1996)- to evaluate self-efficacy in everyday life
Fatigue in MS
Time Frame: 3 months
Modified Fatigue Impact Scale (MFIS - Pavan et al., 2007)- evaluates the level of fatigue in everyday life.
Improvement of overall MS impact in patients life
Time Frame: 3 months
Multiple Sclerosis Impact Scale-29 (MSIS-29 - Hobart J et al, 2001);
Cognition in MS
Time Frame: 3 months
Brief International Cognitive Assessment for MS with will evaluate executive function in MS patients
Secondary Outcomes
- Awareness and attention(3 months)
- Walking speed(3 months)
- Hands strenght(3 months)
- Lymphocyte B activity(3 months)
- Self-compassion(3 months)
- Cyytokine levels(3 months)
- Motor agility(3 months)
- Affects(3 months)
- Correlation between gait and hemodynamic response(3 months)
- Ability to stand up and walk(3 month3)