Multiple SclerosisNCT06128668
The Effect of Yoga on Sleep Quality, Fatigue and Physical Activity Level of Multiple Sclerosis
A study testing Yoga in people with Multiple Sclerosis, run by Ataturk University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Nov 2023to 25 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Relapsing-Remitting Multiple Sclerosis Being an adult between the ages of 18-65
Who cannot join
- Those who have communication problems Those with psychiatric problems Having a condition that prevents you from doing yoga
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Yoga on Sleep Quality, Fatigue and Physical Activity Level of Multiple Sclerosis Patients: A Randomized Controlled Study
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
- Being tested
- Yoga
- Keywords
- Fatigue, Sleep Quality, Yoga
- Medical subject headings
- Multiple Sclerosis, Fatigue, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
Yoga will be applied
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | Yoga will be aplicated Receives: Behavioral: Yoga |
| Control | No intervention | Yoga will not be aplicated |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: six week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start25 Nov 2023
- Primary completion25 Mar 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is an experimental study with pre-test and post-test control groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülcan Bahçecioğlu Turan, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128668
- Sponsor's protocol ID
- 338394
- Status last verified
- Dec 2024
- First submitted
- 24 Oct 2023
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yoga on Sleep Quality, Fatigue and Physical Activity Level of Multiple Sclerosis Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06128668
- Acronym / sponsor ID
- 338394
- Conditions
- Multiple Sclerosis
- Keywords
- Fatigue, Sleep Quality, Yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 25 Nov 2023 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is an experimental study with pre-test and post-test control groups
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: YogaYoga will be aplicated |
| Control | No intervention | –Yoga will not be aplicated |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with Relapsing-Remitting Multiple Sclerosis Being an adult between the ages of 18-65
Key exclusion criteria (1 listed)
- Those who have communication problems Those with psychiatric problems Having a condition that prevents you from doing yoga
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaYoga will be applied | Behavioural | Yoga |
Primary outcome
Pittsburgh Sleep Quality Index
Time frame: 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.
Fatigue Severity Scale:
Time frame: 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.
Expanded Disability Status Scale (EDSS, ExpandedDisabilityStatusScala):
Time frame: 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)
International Physical Activity Questionnaire (IPAQ):
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Multiple Sclerosis, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (time frame: Six week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.