The Effect of Yoga on Sleep Quality, Fatigue and Physical Activity Level of Multiple Sclerosis

NCT06128668 | Completed

• 1 other identifier: 338394
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled study will be conducted to examine the effects of Yoga on Sleep, Fatigue and Physical Activity in Individuals Diagnosed with Relapsing-Remitting Multiple Sclerosis.

Conditions

Multiple Sclerosis

Keywords

Fatigue; Sleep Quality; Yoga

Outcome Measures

Primary Outcomes (4)

• Pittsburgh Sleep Quality Index

  A reliable distinction can be made at the desired level between "good sleepers" and "poor sleepers". The scale contains a total of 24 questions, 19 of which are self-evaluation questions. 5 of them are answered by the individual's spouse or roommate, are used only for clinical information and are not included in the scoring. Question 19, one of the self-assessment questions, is about whether there is a roommate or spouse and is not taken into account in determining the total and component scores of the scale. Scale questions that determine sleep quality include different factors related to sleep quality. These questions are to determine sleep duration, sleep latency, and the frequency and severity of specific sleep-related problems. The 18 items scored were grouped into 7 component scores.

  Six week

• Fatigue Severity Scale:

  The Fatigue Severity Scale is used in most studies evaluating fatigue in MS. The scale consists of 9 questions. Each question consists of 7 points. High scores indicate fatigue. The validity and reliability studies of the scale for Turkey were conducted by Armutlu et al. in 2007, and the Turkish version was also found to be valid and reliable. The scales include the day they were filled in and inquire about fatigue status in the last month. The Fatigue Severity Scale was developed in the 1980s to facilitate the research and treatment of fatigue and to distinguish fatigue from depression and somatic disorders. The survey demonstrated good internal consistency when repeated and across disease responses. The validity of the questionnaire was found to be higher in MS patients.

  six week

• Expanded Disability Status Scale (EDSS, ExpandedDisabilityStatusScala):

  This test, created by Kurtzke, measures disability and neurological symptoms in MS patients. A score is given between 0 and 10. 0 indicates no disability or disorder, while 10 indicates death due to MS. MS patients were divided into 2 groups according to their EDSS scores. EDSS = 6 (requires cane, crutches or other aids to walk)

  six week

• International Physical Activity Questionnaire (IPAQ):

  It obtains data on sitting, walking, moderate-intensity activities and time spent in vigorous activities. In evaluating all activities, the criterion is that each activity should be done for at least 10 minutes at a time. A score as METmin/week is obtained by multiplying the minute, day and MET value. After scoring, physical activity levels are classified as physically inactive (inactive), low physical activity level (minimally active) and sufficient physical activity level (very active). It has short and long forms, and the short form is generally used in studies. The short form consists of 8 questions

  six week

Study Arms (2)

Yoga

EXPERIMENTAL

Yoga will be aplicated

Behavioral: Yoga

Control

NO INTERVENTION

Yoga will not be aplicated

Interventions

Yoga BEHAVIORAL

Yoga will be applied

Yoga

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with Relapsing-Remitting Multiple Sclerosis Being an adult between the ages of 18-65

You may not qualify if:

• Those who have communication problems Those with psychiatric problems Having a condition that prevents you from doing yoga

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Gülcan Bahçecioğlu TURAN

Elâzığ, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue; Sleep Initiation and Maintenance Disorders

Interventions

Yoga

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is an experimental study with pre-test and post-test control groups

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 13, 2023
• Study Start: November 25, 2023
• Primary Completion: March 25, 2024
• Study Completion: July 25, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

TU (1)