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

Multiple Sclerosis Clinical Trial

Official title:

The Effect of Yoga on Sleep Quality, Fatigue and Physical Activity Level of Multiple Sclerosis Patients: A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06128668
• Other study ID #: 338394
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2023
• Est. completion date: May 25, 2024

Study information

• Verified date: December 2023
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 25, 2024
• Est. primary completion date: March 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Yoga
Yoga will be applied

Locations

Country	Name	City	State
Turkey	Gülcan Bahçecioglu TURAN	Elazig

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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