NCT06612138

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable multiple-sclerosis

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

October 10, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

September 21, 2024

Last Update Submit

September 21, 2024

Conditions

Keywords

pilatesyogatai chimultiple scelerosis

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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

    up to six weeks

Secondary Outcomes (3)

  • functional mobility

    up to six weeks

  • fatigue

    up to six weeks

  • life disability

    up to six weeks

Study Arms (4)

Pilates exercises

EXPERIMENTAL

the patients will receive pilates exercise twice a week for six weeks plus traditional

Other: pilates exercisesOther: tradional physical therapy

yoga exercise

EXPERIMENTAL

the patients will receive yoga exercise twice a week for six weeks plus traditional

Other: yoga exercisesOther: tradional physical therapy

tai chi exercises

EXPERIMENTAL

the patients will receive tai chi exercise twice a week for six weeks plus traditional

Other: tai chi exercisesOther: tradional physical therapy

traditional physical therapy

ACTIVE COMPARATOR

the patients will receive tradional physical therapy twice a week for six weeks

Other: tradional physical therapy

Interventions

the patients will receive pilates exercises in the form of breathing exercises, chest lift, bridging, mermaid, swan, quadruped exercises

Pilates 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.

yoga exercise

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.

tai chi exercises

Patients will receive traditional physiotherapy breathing, massage and relaxation exercises

Pilates exercisestai chi exercisestraditional physical therapyyoga exercise

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Central Study Contacts

Alshaymaa s Abd el-azeim, phd

CONTACT

nabil M Abd Al aaL, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
opaque sealed envelope
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: pilates, yoga, tai chi and traditional therapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator: alshaymaa shaaban abd el azeim

Study Record Dates

First Submitted

September 21, 2024

First Posted

September 25, 2024

Study Start

October 10, 2024

Primary Completion

July 30, 2025

Study Completion

July 30, 2025

Last Updated

September 25, 2024

Record last verified: 2024-09