Pilates, Yoga and Tai Chi Exercises' Effect on Balance and Gait in Patients With Multiple Sclerosis (MS)

September 21, 2024 updated by: Al Shaymaa Shaaban Abd El Azeim, Cairo University
this study will be conducted to compare between the effect of Pilates, Yoga and Tai Chi on balance, gait ability, functional mobility and fatigue in patients with multiple sclerosis

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Multiple sclerosis (MS) is a chronic immune-mediated disease involving inflammation, plaques, and demyelination in the central nervous system . MS typically affects people in early adulthood in the 20-40 year range and is two to three times more common in women than men. Exercise therapy is one of the greatest and most well-researched rehabilitation strategies for multiple sclerosis patients. Exercise therapy includes a variety of exercise methods, including resistance training and endurance training, all of which are suitable for multiple sclerosis patients to use. Exercise can alter a wide range of functional and health-related factors as well as the diversity of symptoms displayed by multiple sclerosis patients.Pilates is a method of physical exercise that focuses on core stability, strength, flexibility, posture, muscle control, breathing, and mind-body connection.Yoga therapy is the process of empowering individuals to progress toward improved health and well-being through the application of the philosophy and practice of Yoga. Practicing yoga can provide the tools to help patients with multiple sclerosis cope with the disease and manage everyday tasks in a more beneficial way .Tai Chi is a martial art of Chinese origin that is based on the development of inner energy by practicing predetermined movements softly. It is an intense and complete practice, beneficial at any age. Tai Chi thus falls within a long tradition in Chinese therapies and exercises to improve the individuals' quality of life. 100 patients with multiple sclerosis will be allocated randomly to four groups; group1 will receive pilates plus traditional therapy, group 2 will receive yoga plus traditional therapy, group 3 will receive tai chi plus traditional therapy and group 4 will receive traditional therapy only.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • A score of 3.5 or less on the Expanded Disability Status Scale (EDSS) because individuals with an EDSS score greater than 3.5 need more assistance, being less independent (Zorina et al.,2020).
  • All patients are taking their conventional medical treatment of relapsing-remitting stage
  • Age over than 18 years
  • All definite multiple sclerosis patients diagnosed as MS according to revised McDonald criteria 2017 .
  • Both males and females will be included
  • All Patients will be referred from neurologist.

Exclusion Criteria:

Patients will be excluded if their diagnosis is not clearly established, if they suffer from an acute relapse or severe cognitive deficits, or have signs of any psychiatric disease -Brain surgery/trauma/history of brain disease (stroke), other independent neurological history

  • Another exclusion criterion is the history of cardiac, pulmonary, orthopedic,or other medical conditions diagnosed before participation
  • Rheumatic diseases and other acute or chronic inflammations
  • Vascular disease, spinal cord compression, vitamin B 12 deficiency
  • Other conditions that affect the smooth progress of the inspection: such as hearing impairment, comprehension impairment, poor compliance
  • Alcoholism or drug dependence (addiction)
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pilates exercises
the patients will receive pilates exercise twice a week for six weeks plus traditional
Other: pilates exercises
the patients will receive pilates exercises in the form of breathing exercises, chest lift, bridging, mermaid, swan, quadruped exercises
Other: tradional physical therapy
Patients will receive traditional physiotherapy breathing, massage and relaxation exercises
Experimental: yoga exercise
the patients will receive yoga exercise twice a week for six weeks plus traditional
Other: tradional physical therapy
Patients will receive traditional physiotherapy breathing, massage and relaxation exercises
Other: yoga exercises
the patients will receive yoga in the form of Bhastrikā: rapid and powerful inhalations and exhalations by means of the force of the diaphragm, letting the air sound when exhaling, Nāḏī Śoḏhana: from Sanskrit, "nadi" means 'to channel' and "shodhana" means 'purify, cleanse', o Hand position "Mrigi mudra": It consists of flexing the index and ring fingers of the hand, o Breathing: Gently close the right nostril with the thumb, inhale fingers and exhale slowly through the right. Keeping your right nostril open, inhale, close it, and slowly open and exhale through the left. This is a cycle. Repeat 3-5 times and then release the hand mudra and return to normal breathing.
Experimental: tai chi exercises
the patients will receive tai chi exercise twice a week for six weeks plus traditional
Other: tradional physical therapy
Patients will receive traditional physiotherapy breathing, massage and relaxation exercises
Other: tai chi exercises
the patients will receive tai chi in the form of Commencing form, Repulse Monkey,Grasp Peacock's Tail,Move Hands like Moving Clouds (left side only), Fair Lady Works at Shuttles, Golden Cock Stands on One Leg (left and right),Brush Knees and Twist Steps, Closing form.
Active Comparator: traditional physical therapy
the patients will receive tradional physical therapy twice a week for six weeks
Other: tradional physical therapy
Patients will receive traditional physiotherapy breathing, massage and relaxation exercises

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
balance
Time Frame: up to six weeks
The Berg Balance Scale (BBS) was developed to measure balance. The BBS consists of 14 functional balance items.Each item is scored on a 5-point ordinal scale ranging from 0 to 4, with 0 indicating an inability to complete the task entirely and 4 indicating an ability to complete the task criterion.A score of 56 indicates functional balance; and scores below 45 indicate greater risk for falling.
up to six weeks
gait assessment
Time Frame: up to six weeks
12-Item Multiple Sclerosis Walking Scale is valid and reliable to assess gait ability in patients with multiple sclerosis. Patients are asked to answer 12 questions about limitations to their walking due to MS over the past 2 weeks, circling a number that best describes their degree of restriction (1, not at all; 2, a little; 3, moderately; 4, quite a bit; 5, extremely). Higher scores indicate the higher impact of the disease on walking. Finally, the score of walking ability falls into a 48-point range with minimum and maximum scores of 12 and 60.
up to six weeks
exercise capacity
Time Frame: up to six weeks
6 Minute Walk Test is valid and reliable for the evaluation of exercise capacity.The patient is instructed to 'walk at your comfortable pace' back and forth along a hallway for 6 minutes. The maximum distance walked is measured and recorded
up to six weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
functional mobility
Time Frame: up to six weeks
Timed up and go test (TUG) is valid and reliable for the evaluation of functional mobility in patients with multiple sclerosis.A score of ≥ 14 seconds has been shown to indicate high risk of fall, while score ≤10 seconds = normal, score ≤ 20 seconds = good mobility, can go out alone, mobile without gait aid, score ≤ 30 seconds = problems and cannot go outside alone and requires gait aid
up to six weeks
fatigue
Time Frame: up to six weeks
The Fatigue Severity Scale (FSS), originally developed by Krupp for use in patients with MS, has been used to measure fatigue. It consists of 9 items.patients score each item from 1 to 7, based on the extent, to which they agree or disagree with each statement (1 = strong disagreement, 7 = strong agreement). The FSS can be scored either by obtaining a total score, or by calculating a mean score across all 9 items, with higher scores indicating more severe fatigue
up to six weeks
life disability
Time Frame: up to six weeks
Multiple sclerosis quality of life questionnaire will be used to assess life disability. MSQoL-54 scale scores were created using the Likert method by averaging items within the scales and, then row scores were linearly transformed into 0-100 scales. Higher values indicate better quality of life.
up to six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P.T.REC/012/005332

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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