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

Primary Purpose

Multiple Sclerosis

Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Iyengar Yoga
Yoga app
Sponsored by
Hospital Israelita Albert Einstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital Israelita Albert Einstein

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

No Intervention

Experimental

No Intervention

No Intervention

Arm Label

MS patients with EDSS from 0 to 5.5 for yoga

MS patients with EDSS from 0 to 5.5 for control

MS patients with EDSS from 6 to 8 for yoga

MS patients with EDSS from 6 to 8 for control

Healthy subjects

Arm Description

Three months of Iyengar Yoga practice.

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

Outcomes

Primary Outcome Measures

Improvement of overall MS impact in patients life
Multiple Sclerosis Impact Scale-29 (MSIS-29 - Hobart J et al, 2001);
Cognition in MS
Brief International Cognitive Assessment for MS with will evaluate executive function in MS patients
Fatigue in MS
Modified Fatigue Impact Scale (MFIS - Pavan et al., 2007)- evaluates the level of fatigue in everyday life.
Self-efficacy in MS
MS Self-Efficacy Scale (MSSE - Schwartz et al., 1996)- to evaluate self-efficacy in everyday life

Secondary Outcome Measures

Cyytokine levels
The immune system response to the intervention will be evaluated through cytokines levels
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.
Motor agility
9-hole Peg Test (9-HPT - Grice et al., 2003);
Awareness and attention
Mindful attention awareness scale (Brown & Ryan 2003);
Lymphocyte B activity
The immune system response to the intervention will be also evaluated through the Lymphocyte B activity
Walking speed
Timed 25 foot walk - (National Multiple Sclerosis Society, 2016);
Ability to stand up and walk
Timed up & go (Podsiadlo & Richardson, 1991);
Hands strenght
Hand grip (Godoy, 2005 );
Self-compassion
Self-compassion scale (Neff, 2003);
Affects
Positive and Negative Affect Schedule (PANAS - Carvalho, 2013);

Full Information

First Posted
April 4, 2017
Last Updated
January 10, 2022
Sponsor
Hospital Israelita Albert Einstein
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1. Study Identification

Unique Protocol Identification Number
NCT03198598
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 19, 2017 (Actual)
Primary Completion Date
December 26, 2022 (Anticipated)
Study Completion Date
December 26, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Israelita Albert Einstein

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MS patients with EDSS from 0 to 5.5 for yoga
Arm Type
Experimental
Arm Description
Three months of Iyengar Yoga practice.
Arm Title
MS patients with EDSS from 0 to 5.5 for control
Arm Type
No Intervention
Arm Title
MS patients with EDSS from 6 to 8 for yoga
Arm Type
Experimental
Arm Description
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
Arm Title
MS patients with EDSS from 6 to 8 for control
Arm Type
No Intervention
Arm Title
Healthy subjects
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Iyengar Yoga
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Yoga app
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement of overall MS impact in patients life
Description
Multiple Sclerosis Impact Scale-29 (MSIS-29 - Hobart J et al, 2001);
Time Frame
3 months
Title
Cognition in MS
Description
Brief International Cognitive Assessment for MS with will evaluate executive function in MS patients
Time Frame
3 months
Title
Fatigue in MS
Description
Modified Fatigue Impact Scale (MFIS - Pavan et al., 2007)- evaluates the level of fatigue in everyday life.
Time Frame
3 months
Title
Self-efficacy in MS
Description
MS Self-Efficacy Scale (MSSE - Schwartz et al., 1996)- to evaluate self-efficacy in everyday life
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Cyytokine levels
Description
The immune system response to the intervention will be evaluated through cytokines levels
Time Frame
3 months
Title
Correlation between gait and hemodynamic response
Description
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.
Time Frame
3 months
Title
Motor agility
Description
9-hole Peg Test (9-HPT - Grice et al., 2003);
Time Frame
3 months
Title
Awareness and attention
Description
Mindful attention awareness scale (Brown & Ryan 2003);
Time Frame
3 months
Title
Lymphocyte B activity
Description
The immune system response to the intervention will be also evaluated through the Lymphocyte B activity
Time Frame
3 months
Title
Walking speed
Description
Timed 25 foot walk - (National Multiple Sclerosis Society, 2016);
Time Frame
3 months
Title
Ability to stand up and walk
Description
Timed up & go (Podsiadlo & Richardson, 1991);
Time Frame
3 month3
Title
Hands strenght
Description
Hand grip (Godoy, 2005 );
Time Frame
3 months
Title
Self-compassion
Description
Self-compassion scale (Neff, 2003);
Time Frame
3 months
Title
Affects
Description
Positive and Negative Affect Schedule (PANAS - Carvalho, 2013);
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Hospital Israelita Albert Einstein
City
Sao Paulo
ZIP/Postal Code
05652901
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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