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

Sponsor
Ataturk University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06128668
Collaborator
(none)
80
1
2
6
13.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Yoga
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study is an experimental study with pre-test and post-test control groupsThis study is an experimental study with pre-test and post-test control groups
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Yoga on Sleep Quality, Fatigue and Physical Activity Level of Multiple Sclerosis Patients: A Randomized Controlled Study
Anticipated Study Start Date :
Nov 25, 2023
Anticipated Primary Completion Date :
Mar 25, 2024
Anticipated Study Completion Date :
May 25, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Yoga

Yoga will be aplicated

Behavioral: Yoga
Yoga will be applied

No Intervention: Control

Yoga will not be aplicated

Outcome Measures

Primary Outcome Measures

  1. Pittsburgh Sleep Quality Index [Six week]

    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.

  2. Fatigue Severity Scale: [six week]

    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.

  3. Expanded Disability Status Scale (EDSS, ExpandedDisabilityStatusScala): [six week]

    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)

  4. International Physical Activity Questionnaire (IPAQ): [six week]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gülcan Bahçecioğlu TURAN Elazığ Turkey

Sponsors and Collaborators

  • Ataturk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
gülcan bahcecioğlu, Principal Investigator, Ataturk University
ClinicalTrials.gov Identifier:
NCT06128668
Other Study ID Numbers:
  • 338394
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by gülcan bahcecioğlu, Principal Investigator, Ataturk University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2023