NCT07155642

Brief Summary

Objective The objective of this study will be to compare the effects of an eight-week Yin-based yoga program and conventional physiotherapy on fatigue, balance, gait, and quality of life in individuals with Multiple Sclerosis (MS). Methods Twenty patients with MS will be randomly assigned to either a yoga group (n = 10) or a physiotherapy group (n = 10). Both groups will participate in supervised sessions lasting 60 minutes per day, three days per week, over an eight-week period. The yoga intervention will be Yin-based, incorporating centering, yoga postures, breathing exercises, and relaxation. The physiotherapy program will consist of aerobic training, strengthening and spinal stabilization exercises, balance and coordination activities, and stretching. Outcome measures will include the Fatigue Severity Scale (FSS) for fatigue, the Berg Balance Scale (BBS) for balance, the 12-item Multiple Sclerosis Walking Scale (MSWS-12) for gait, and the Multiple Sclerosis Quality of Life Questionnaire (MSQOL-54) for physical and mental health-related quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2019

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 4, 2025

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

August 24, 2025

Last Update Submit

September 1, 2025

Conditions

Keywords

multiple sclerosisyogafatiguebalancequality of life

Outcome Measures

Primary Outcomes (2)

  • MS Walking Scale (MSWS-12)

    The MSWS-12 is a 12-item self-reported questionnaire that assesses the impact of MS on walking ability over the past two weeks. Items are rated on a 5-point scale (1: almost never, 5: extremely). Higher scores indicate greater perceived walking limitations or difficulties

    3 months

  • MS Quality of Life-54 (MSQOL-54)

    The MSQOL-54 is a disease-specific quality of life questionnaire for MS patients. It comprises 31 questions divided into three sub-dimensions: psychological, physical, and psychosocial quality of life. Lower scores indicate a higher quality of life

    3 months

Secondary Outcomes (2)

  • Fatigue Severity Scale (FSS)

    3 months

  • Berg Balance Scale (BBS)

    3 months

Study Arms (2)

yoga

EXPERIMENTAL

Participants in the yoga group received a total of 8 weeks of intervention, conducted 3 days a week, for 60 minutes per day. The program components were: * 8 minutes of meditation practice. * 40 minutes of Yin and Yang yoga postures. (It's highly recommended to briefly explain what "Yin and Yang yoga postures" specifically entail in the full paper's methodology section, e.g., "Yin yoga focuses on holding passive poses for longer durations to target deep connective tissues, while Yang yoga incorporates more active, flowing sequences to build strength and flexibility.") * 2 minutes of breathing exercises (pranayama). * 10 minutes of deep relaxation (savasana).

Other: yoga

Conventional Physiotherapy

ACTIVE COMPARATOR

Participants in the conventional physiotherapy group also underwent an 8-week program, 3 days a week, for 60 minutes per day. This program included: * Aerobic exercises. * Stretching exercises. * Strengthening exercises. * Spinal stabilization exercises. * Balance exercises.

Other: conventional physiotheraphy

Interventions

yogaOTHER

Participants in the yoga group received a total of 8 weeks of intervention, conducted 3 days a week, for 60 minutes per day. The program components were: • 8 minutes of meditation practice. • 40 minutes of Yin and Yang yoga postures. (It's highly recommended to briefly explain what "Yin and Yang yoga postures" specifically entail in the full paper's methodology section, e.g., "Yin yoga focuses on holding passive poses for longer durations to target deep connective tissues, while Yang yoga incorporates more active, flowing sequences to build strength and flexibility.") • 2 minutes of breathing exercises (pranayama). • 10 minutes of deep relaxation (savasana).

yoga

Participants in the conventional physiotherapy group also underwent an 8-week program, 3 days a week, for 60 minutes per day. This program included: * Aerobic exercises. * Stretching exercises. * Strengthening exercises. * Spinal stabilization exercises. * Balance exercises.

Conventional Physiotherapy

Eligibility Criteria

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

You may qualify if:

  • Being between 18-65 years of age.
  • Voluntarily giving informed consent to participate in the study.
  • Having either Relapsing-Remitting MS (RRMS) or Secondary Progressive MS (SPMS) type.
  • An Expanded Disability Status Scale (EDSS) score of 5.5 or below.
  • No MS exacerbation within the last 4 weeks.
  • Possessing the willingness, ability, and cognitive intactness to participate in the interventions.

You may not qualify if:

  • Using medication specifically for fatigue.
  • Presence of major sleep disorders, clinical depression, hypothyroidism, or B12 deficiency.
  • Severe balance problems (e.g., Central Vestibular Disorders (CVO), peripheral neuropathy, Meniere's disease, vertigo).
  • Having received corticosteroid treatment within the last 4 weeks.
  • Pregnancy.
  • Serious cardiovascular disease, hypertension, or orthopedic limitations.
  • Presence of Carpal Tunnel Syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Öziri

Ataşehir, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple SclerosisFatigue

Interventions

Yoga

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 24, 2025

First Posted

September 4, 2025

Study Start

March 4, 2019

Primary Completion

April 20, 2019

Study Completion

June 7, 2019

Last Updated

September 4, 2025

Record last verified: 2025-08

Locations