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

NCT03198598 | Active Not Recruiting DMC

• 1 other identifier: HIAE_EscleroseMultipla_Yoga
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

• Improvement of overall MS impact in patients life

  Multiple Sclerosis Impact Scale-29 (MSIS-29 - Hobart J et al, 2001);

  3 months

• Cognition in MS

  Brief International Cognitive Assessment for MS with will evaluate executive function in MS patients

  3 months

• Fatigue in MS

  Modified Fatigue Impact Scale (MFIS - Pavan et al., 2007)- evaluates the level of fatigue in everyday life.

  3 months

• Self-efficacy in MS

  MS Self-Efficacy Scale (MSSE - Schwartz et al., 1996)- to evaluate self-efficacy in everyday life

  3 months

Secondary Outcomes (10)

• Cyytokine levels

  3 months

• Correlation between gait and hemodynamic response

  3 months

• Motor agility

  3 months

• Awareness and attention

  3 months

• Lymphocyte B activity

  3 months

Study Arms (5)

MS patients with EDSS from 0 to 5.5 for yoga

EXPERIMENTAL

Three months of Iyengar Yoga practice.

Behavioral: Iyengar Yoga

MS patients with EDSS from 0 to 5.5 for control

NO INTERVENTION

MS patients with EDSS from 6 to 8 for yoga

EXPERIMENTAL

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

Behavioral: Yoga app

MS patients with EDSS from 6 to 8 for control

NO INTERVENTION

Healthy subjects

NO INTERVENTION

Interventions

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.

MS patients with EDSS from 0 to 5.5 for yoga

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.

MS patients with EDSS from 6 to 8 for yoga

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• presents clinical or radiological disease activity for the last 6 months
• no cognitive capacity to understand the written informed consent form

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, 05652901, Brazil

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: June 26, 2017
• Study Start: June 19, 2017
• Primary Completion (Estimated): December 26, 2026
• Study Completion (Estimated): December 26, 2026
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)