Multiple SclerosisNCT05402956
Aerobic Exercise in Persons With Multiple Sclerosis With Restless Legs Syndrome
A study testing Aerobic exercise in people with Multiple Sclerosis, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
In this studly, the effects of an 12-week aerobic exercise training in persons with multiple sclerosis with restless legs syndrome will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2022to Dec 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A relapsing-remitting or secondary progressive type of multiple sclerosis,
- To be willing to participate in the study.
Who cannot join
- Another neurological disorder,
- Orthopedic surgery history including the ankle-foot, knee, hip, or spine, affecting balance,
- Diagnosed severe cognitive and/or psychiatric impairment,
- Having congestive heart failure, coronary, cerebrovascular, and pulmonary disease such as COPD
- Having cardiac disease such as hypertension that would be a contraindication to exercise
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dokuz Eylul University Hospital, MS Outpatient Clinic
Izmir, 35430
Serkan Ozakbas, MD, +902324124064 ext. 4064, serkan.ozakbas@gmail.com
Turhan Kahraman, PhD
About this study
Official title: Effect of Aerobic Exercise Training in Persons With Multiple Sclerosis With Restless Legs Syndrome
In this studly, the effects of an 12-week aerobic exercise training in persons with multiple sclerosis with restless legs syndrome will be investigated.
- Conditions
- Multiple Sclerosis
- Being tested
- Aerobic exercise
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
Moderate aerobic exercise training
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | Not described Receives: Behavioral: Aerobic exercise |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Restless Legs Syndrome Study Group rating scale for restless legs syndrome
The International Restless Legs Syndrome Study Group rating scale for restless legs syndrome is used to assess severity of the restless legs syndrome symptoms. It consists of 10 items scored by 0 to 4. Possible scores range from 0 to 40. Higher scores indicate higher severity.
Measured: Change from Baseline at 12 weeks
Secondary outcomes (9)
Timed 25-Foot Walk
The Timed 25-Foot Walk is a quantitative mobility and leg function performance test based on a timed 25-walk. he patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The score is the average of the two completed trials. Higher time represents slower walking speed and more walking impairment.
Measured: Change from Baseline at 12 weeks
12-Item Multiple sclerosis walking scale
The 12-Item Multiple sclerosis walking scale is a self-assessment scale which measures the impact of multiple sclerosis on walking. It consists of 12 questions with Likert-type choose options concerning the limitations to walking due to multiple sclerosis during the past 2 weeks. Total score ranges 0 from 100. Higher scores indicate more impact of multiple sclerosis on walking.
Measured: Change from Baseline at 12 weeks
Epworth Sleepiness Scale
The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness'.
Measured: Change from Baseline at 12 weeks
Multiple Sclerosis International Quality of Life questionnaire
The Multiple Sclerosis International Quality of Life questionnaire is a disease-specific, self-administered, multidimensional questionnaire, was co-developed and initially validated in 15 countries including Turkey. The questionnaire comprises 31 questions in 9 subscales: activities of daily living, psychological well-being, symptoms, relationships with friends, relationships with family, sentimental and sexual life, coping, rejection, and relationships with healthcare system. All 9 dimensions and the index score were linearly transformed and standardized on a 0-100 scale, where 0 indicates the worst possible level of quality of life and 100 indicates the best level.
Measured: Change from Baseline at 12 weeks
Pittsburgh Sleep Quality Index
Detect sleep disturbances or deficits.
Measured: Change from Baseline at 12 weeks
Time Up and Go Test
Assessments will be performed with APDM Opals.
Measured: Change from Baseline at 12 weeks
Six-Minute Walk Test
The 6-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The goal is for the individual to walk as far and fast as possible in 6 minutes. The total distance is recorded. Higher distance represents a better submaximal exercise capacity.
Measured: Change from Baseline at 12 weeks
Two-Minute Walk Test
Assessments will be performed with APDM Opals.
Measured: Change from Baseline at 12 weeks
Estimated VO2 Max
Estimated VO2max will be calculated Astrand-Rhyming Cycle Ergometer Test.
Measured: Change from Baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start30 May 2022
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Turhan Kahraman, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402956
- Sponsor's protocol ID
- 2022/12-18
- Status last verified
- Jun 2022
- First submitted
- 30 May 2022
- Last updated
- 6 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercise Training in Persons With Multiple Sclerosis With Restless Legs Syndrome
- ClinicalTrials.gov ID
- NCT05402956
- Acronym / sponsor ID
- 2022/12-18
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 2 Jun 2022 (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.
In this studly, the effects of an 12-week aerobic exercise training in persons with multiple sclerosis with restless legs syndrome will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Behavioral: Aerobic exercise |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A relapsing-remitting or secondary progressive type of multiple sclerosis,
- To be willing to participate in the study.
Key exclusion criteria (5 listed)
- Another neurological disorder,
- Orthopedic surgery history including the ankle-foot, knee, hip, or spine, affecting balance,
- Diagnosed severe cognitive and/or psychiatric impairment,
- Having congestive heart failure, coronary, cerebrovascular, and pulmonary disease such as COPD
- Having cardiac disease such as hypertension that would be a contraindication to exercise
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 |
|---|---|---|
| Aerobic exerciseModerate aerobic exercise training | Behavioural | Aerobic exercise |
Primary outcome
International Restless Legs Syndrome Study Group rating scale for restless legs syndrome
Time frame: Change from Baseline at 12 weeks
The International Restless Legs Syndrome Study Group rating scale for restless legs syndrome is used to assess severity of the restless legs syndrome symptoms. It consists of 10 items scored by 0 to 4. Possible scores range from 0 to 40. Higher scores indicate higher severity.
9 secondary outcomes
Timed 25-Foot Walk
Time frame: Change from Baseline at 12 weeks
12-Item Multiple sclerosis walking scale
Time frame: Change from Baseline at 12 weeks
Epworth Sleepiness Scale
Time frame: Change from Baseline at 12 weeks
Multiple Sclerosis International Quality of Life questionnaire
Time frame: Change from Baseline at 12 weeks
Pittsburgh Sleep Quality Index
Time frame: Change from Baseline at 12 weeks
Time Up and Go Test
Time frame: Change from Baseline at 12 weeks
Six-Minute Walk Test
Time frame: Change from Baseline at 12 weeks
Two-Minute Walk Test
Time frame: Change from Baseline at 12 weeks
Estimated VO2 Max
Time frame: Change from Baseline at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
Dokuz Eylul University Hospital, MS Outpatient Clinic
Izmir, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Multiple Sclerosis, run by Dokuz Eylul 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Restless Legs Syndrome Study Group rating scale for restless legs syndrome (time frame: Change from Baseline at 12 weeks). 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 6 Jun 2022; AzTrials last refreshed its copy on 30 Oct 2026.