Multiple SclerosisMSNCT06612138
Pilates, Yoga and Tai Chi Exercises' Effect on Balance and Gait in Patients With Multiple Sclerosis
A study testing pilates exercises, yoga exercises and tai chi exercises in people with Multiple Sclerosis, run by Cairo University.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- pilates exercises, yoga exercises and tai chi exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- pilates exercises, yoga exercises, tai chi exercises, tradional physical therapy
- Keywords
- pilates, yoga, tai chi, multiple scelerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pilates exercisesOther
the patients will receive pilates exercises in the form of breathing exercises, chest lift, bridging, mermaid, swan, quadruped exercises
yoga exercisesOther
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.
tai chi exercisesOther
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.
tradional physical therapyOther
Patients will receive traditional physiotherapy breathing, massage and relaxation exercises
| Study group | Role | What they receive |
|---|---|---|
| Pilates exercises | Experimental | the patients will receive pilates exercise twice a week for six weeks plus traditional Receives: Other: pilates exercises; Other: tradional physical therapy |
| yoga exercise | Experimental | the patients will receive yoga exercise twice a week for six weeks plus traditional Receives: Other: yoga exercises; Other: tradional physical therapy |
| tai chi exercises | Experimental | the patients will receive tai chi exercise twice a week for six weeks plus traditional Receives: Other: tai chi exercises; Other: tradional physical therapy |
| traditional physical therapy | Active comparator | the patients will receive tradional physical therapy twice a week for six weeks Receives: Other: tradional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
balance
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.
Measured: up to six weeks
gait assessment
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.
Measured: up to six weeks
exercise capacity
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
Measured: up to six weeks
Secondary outcomes (3)
functional mobility
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
Measured: up to six weeks
fatigue
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
Measured: up to six weeks
life disability
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.
Measured: up to six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start10 Oct 2024 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pilates, yoga, tai chi and traditional therapy
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Al Shaymaa Shaaban Abd El Azeim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612138
- Sponsor's protocol ID
- P.T.REC/012/005332
- Acronym
- MS
- Status last verified
- Sep 2024
- First submitted
- 21 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilates, Yoga and Tai Chi Exercises' Effect on Balance and Gait in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06612138
- Acronym / sponsor ID
- MS / P.T.REC/012/005332
- Conditions
- Multiple Sclerosis
- Keywords
- pilates, yoga, tai chi, multiple scelerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- pilates, yoga, tai chi and traditional therapy
| Arm | Type | Receives |
|---|---|---|
| Pilates exercises | Experimental | Other: pilates exercises, Other: tradional physical therapythe patients will receive pilates exercise twice a week for six weeks plus traditional |
| yoga exercise | Experimental | Other: yoga exercises, Other: tradional physical therapythe patients will receive yoga exercise twice a week for six weeks plus traditional |
| tai chi exercises | Experimental | Other: tai chi exercises, Other: tradional physical therapythe patients will receive tai chi exercise twice a week for six weeks plus traditional |
| traditional physical therapy | Active comparator | Other: tradional physical therapythe patients will receive tradional physical therapy twice a week for six weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pilates exercisesthe patients will receive pilates exercises in the form of breathing exercises, chest lift, bridging, mermaid, swan, quadruped exercises | Other | Pilates exercises |
| yoga exercisesthe 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. | Other | yoga exercise |
| tai chi exercisesthe 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. | Other | tai chi exercises |
| tradional physical therapyPatients will receive traditional physiotherapy breathing, massage and relaxation exercises | Other | Pilates exercises, tai chi exercises, traditional physical therapy, yoga exercise |
Primary outcome
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.
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.
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
3 secondary outcomes
functional mobility
Time frame: up to six weeks
fatigue
Time frame: up to six weeks
life disability
Time frame: up to six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing pilates exercises, yoga exercises and tai chi exercises in people with Multiple Sclerosis, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alshaymaa s Abd el-azeim, phd (01033771553, alshaymaa.shaaban@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
balance (time frame: up to six weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.