MULTIPL SCLEROSİSNCT07771868
High-Intensity Interval Training for Walking and Function Across Different Multiple Sclerosis Disability Levels
A study testing High-Intensity Interval Training in people with MULTIPL SCLEROSİS, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Multiple Sclerosis (MS) is a chronic neurological disease that can affect daily functioning, mobility, and overall quality of life. High-Intensity Interval Training (HIIT) is known to be a time-efficient exercise approach that improves exercise capacity and reduces fatigue in MS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- MULTIPL SCLEROSİS
- What is being tested?
- High-Intensity Interval Training
- 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
- 1 Sep 2026to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Be between the ages of 18 and 65,
- Have been diagnosed with MS by a treating physician,
- Have an EDSS score between 0 and 6.5,
- Not having experienced a relapse within the last 3 months,
- Not having severe lower extremity contractures, severe spasticity (≥3 on the Modified Ashworth Scale), or an acute orthopedic problem that would prevent the participant from pedaling on a bicycle ergometer,
- Having a Mini Mental State Examination score of ≥24.
Who cannot join
- Having a severe cardiovascular, orthopedic, respiratory, or metabolic disease,
- Having an additional neurological condition,
- Being pregnant or suspecting pregnancy,
- Having received a botulinum toxin injection within the last 3 months,
- Having a COMPASS-31 total score greater than 13.6
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hatay Mustafa Kemal Universty
Hatay
Yasemin Karaaslan, Phd, ptyasemindeveci@gmail.com
About this study
Official title: The Effect of High-Intensity Interval Training on Maximum Walking Distance and Functional Parameters in Patients With Multiple Sclerosis at Different Disability Levels
Multiple Sclerosis (MS) is a chronic neurological disease that can affect daily functioning, mobility, and overall quality of life. High-Intensity Interval Training (HIIT) is known to be a time-efficient exercise approach that improves exercise capacity and reduces fatigue in MS. However, current research lacks sufficient data on how HIIT affects individuals with different levels of disability.
The main purpose of this study is to evaluate the effects of a stationary bicycle-based HIIT protocol on maximum walking distance, fatigue, balance, muscle strength, endurance, gait speed, and quality of life in MS patients across three different disability levels: mild, moderate, and severe (classified according to Expanded Disability Status Scale - EDSS scores).
Read more
Participants will complete a cycle ergometer-based HIIT program. Assessments will be conducted at three time points:
Before starting the exercise program (baseline)
Immediately after completing the program (post-treatment)
4 weeks after the completion of the program (follow-up)
To ensure unbiased results, a triple-blind design will be used, meaning the outcome assessor, the treating physiotherapist, and the data analyst will be blinded to group assignments. The findings aim to help clinicians tailor personalized, effective HIIT protocols based on a patient's specific disability level rather than using a standardized, one-size-fits-all approach in MS rehabilitation.
- Conditions
- MULTIPL SCLEROSİS
- Being tested
- High-Intensity Interval Training
- Keywords
- Multiple Sclerosis, High-Intensity Interval Training, Cycle Ergometer, Expanded Disability Status Scale
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval TrainingBehavioural
All exercise sessions in our study will be conducted using a bicycle ergometer (Monark Cardio Care 827 X, Monark Exercise AB, Sweden). The HIIT protocol will consist of five 3-minute high-intensity intervals performed at 80-100 revolutions per minute, corresponding to 85-90% of maximum heart rate. Between these intervals, active rest periods will be implemented, during which cadence is reduced to 50-60 revolutions per minute for 1.5 minutes to lower heart rate to 50-60% of maximum heart rate. The total training duration is planned to be 20 minutes, consisting of a 2-minute warm-up at the beginning and a 2-minute cool-down at the end. Sessions will be conducted three times a week. The total treatment duration is planned to be 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mild Disability Group (EDSS 0 to <=2.5) | Experimental | Not described Receives: Behavioral: High-Intensity Interval Training |
| Moderate Disability Group (EDSS 3.0 to <=4.5) | Experimental | Not described Receives: Behavioral: High-Intensity Interval Training |
| Severe Disability Group (EDSS 5.0 to <=6.5) | Experimental | Not described Receives: Behavioral: High-Intensity Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Walking Distance
Maximum walking distance (in meters) will be objectively estimated using a predictive model previously developed by our research team.
Measured: Assessed at baseline (pre-intervention), immediately post-intervention (at 8 weeks), and 4 weeks post-intervention (follow-up)
Secondary outcomes (7)
Fatigue
Fatigue will be evaluated with the Fatigue Severity Scale. This scale also assesses the fatigue severity of patients through 9 questions. Each question has a score ranging from 1 (strongly disagree) to 7 (strongly agree). The fatigue severity scale score is determined by calculating the average value of the responses given to these 9 questions. A higher score indicates greater fatigue severity.
Measured: Baseline, immediately post-intervention, and 4 weeks follow-up
Muscle Strength
It will be evaluated using a hand-held dynamometer. In this test, which will be performed in a long-sitting position with the hips in 90 degrees of flexion and the knees in extension, the measuring device (Lafayette Instrument Company, Lafayette IN, USA) will be placed on the sole of the foot. The patient will then be asked to press their foot downward, and the result will be recorded.
Measured: Baseline, immediately post-intervention, and 4 weeks follow-up
Muscular Endurance
It will be evaluated through repetitive muscle contraction tests.
Measured: Baseline, immediately post-intervention, and 4 weeks follow-up
Gait Speed
The walking speeds of the participants will be evaluated using the 10-Meter Walk Test, whose validity and reliability have been proven in clinical studies. During the assessment, participants will be asked to walk along a 10-meter straight and obstacle-free corridor at their normal pace, and the elapsed time will be recorded using a stopwatch.
Measured: Baseline, immediately post-intervention, and 4 weeks follow-up
Health-Related Quality of Life
It will be evaluated using the Multiple Sclerosis Impact Scale-29. The questionnaire assesses the impact of MS on daily life over the past two weeks. Responses are recorded on a 5-point Likert scale ranging from 1 ("not at all") to 5 ("extremely").
Measured: Baseline, immediately post-intervention, and 4 weeks follow-up
balance
Objective balance assessments of the participants will be performed using the TecnoBody PK200 Balance Device. As part of the assessment protocol, patients will sequentially undergo stabilometric static balance, the Romberg test in eyes-open and eyes-closed positions, single-leg stance on the right and left, and dynamic balance tests.
Measured: Baseline, immediately post-intervention, and 4 weeks follow-up
Dynamic Balance
It will be evaluated using the Community Balance and Mobility Scale. This scale evaluates balance and mobility status across 13 tasks that involve advanced functional balance and mobility activities. Each item is scored between 0 and 5 (0 = unable to perform, 5 = able to perform independently). Item 12 is scored from 0 to 6, with an additional point added if a basket is carried while descending the stairs. Higher scores indicate better balance and mobility.
Measured: Baseline, immediately post-intervention, and 4 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Sep 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MULTIPL SCLEROSİSStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ISMAIL KARA, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771868
- Sponsor's protocol ID
- Hacettepe-PT-MS-01
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High-Intensity Interval Training on Maximum Walking Distance and Functional Parameters in Patients With Multiple Sclerosis at Different Disability Levels
- ClinicalTrials.gov ID
- NCT07771868
- Acronym / sponsor ID
- Hacettepe-PT-MS-01
- Conditions
- MULTIPL SCLEROSİS
- Keywords
- Multiple Sclerosis, High-Intensity Interval Training, Cycle Ergometer, Expanded Disability Status Scale
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 18 Aug 2026 (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.
Multiple Sclerosis (MS) is a chronic neurological disease that can affect daily functioning, mobility, and overall quality of life. High-Intensity Interval Training (HIIT) is known to be a time-efficient exercise approach that improves exercise capacity and reduces fatigue in MS. However, current research lacks sufficient data on how HIIT affects individuals with different levels of disability.
The main purpose of this study is to evaluate the effects of a stationary bicycle-based HIIT protocol on maximum walking distance, fatigue, balance, muscle strength, endurance, gait speed, and quality of life in MS patients across three different disability levels: mild, moderate, and severe (classified according to Expanded Disability Status Scale - EDSS scores).
Participants will complete a cycle ergometer-based HIIT program. Assessments will be conducted at three time points:
Before starting the exercise program (baseline)
Immediately after completing the program (post-treatment)
4 weeks after the completion of the program (follow-up)
To ensure unbiased results, a triple-blind design will be used, meaning the outcome assessor, the treating physiotherapist, and the data analyst will be blinded to group assignments. The findings aim to help clinicians tailor personalized, effective HIIT protocols based on a patient's specific disability level rather than using a standardized, one-size-fits-all approach in MS rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild Disability Group (EDSS 0 to <=2.5) | Experimental | Behavioral: High-Intensity Interval Training |
| Moderate Disability Group (EDSS 3.0 to <=4.5) | Experimental | Behavioral: High-Intensity Interval Training |
| Severe Disability Group (EDSS 5.0 to <=6.5) | Experimental | Behavioral: High-Intensity Interval Training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be between the ages of 18 and 65,
- Have been diagnosed with MS by a treating physician,
- Have an EDSS score between 0 and 6.5,
- Not having experienced a relapse within the last 3 months,
- Not having severe lower extremity contractures, severe spasticity (≥3 on the Modified Ashworth Scale), or an acute orthopedic problem that would prevent the participant from pedaling on a bicycle ergometer,
Key exclusion criteria (5 listed)
- Having a severe cardiovascular, orthopedic, respiratory, or metabolic disease,
- Having an additional neurological condition,
- Being pregnant or suspecting pregnancy,
- Having received a botulinum toxin injection within the last 3 months,
- Having a COMPASS-31 total score greater than 13.6
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 |
|---|---|---|
| High-Intensity Interval TrainingAll exercise sessions in our study will be conducted using a bicycle ergometer (Monark Cardio Care 827 X, Monark Exercise AB, Sweden). The HIIT protocol will consist of five 3-minute high-intensity intervals performed at 80-100 revolutions per minute, corresponding to 85-90% of maximum heart rate. Between these intervals, active rest periods will be implemented, during which cadence is reduced to 50-60 revolutions per minute for 1.5 minutes to lower heart rate to 50-60% of maximum heart rate. The total training duration is planned to be 20 minutes, consisting of a 2-minute warm-up at the beginning and a 2-minute cool-down at the end. Sessions will be conducted three times a week. The total treatment duration is planned to be 8 weeks. | Behavioural | Mild Disability Group (EDSS 0 to <=2.5), Moderate Disability Group (EDSS 3.0 to <=4.5), Severe Disability Group (EDSS 5.0 to <=6.5) |
Primary outcome
Maximum Walking Distance
Time frame: Assessed at baseline (pre-intervention), immediately post-intervention (at 8 weeks), and 4 weeks post-intervention (follow-up)
Maximum walking distance (in meters) will be objectively estimated using a predictive model previously developed by our research team.
7 secondary outcomes
Fatigue
Time frame: Baseline, immediately post-intervention, and 4 weeks follow-up
Muscle Strength
Time frame: Baseline, immediately post-intervention, and 4 weeks follow-up
Muscular Endurance
Time frame: Baseline, immediately post-intervention, and 4 weeks follow-up
Gait Speed
Time frame: Baseline, immediately post-intervention, and 4 weeks follow-up
Health-Related Quality of Life
Time frame: Baseline, immediately post-intervention, and 4 weeks follow-up
balance
Time frame: Baseline, immediately post-intervention, and 4 weeks follow-up
Dynamic Balance
Time frame: Baseline, immediately post-intervention, and 4 weeks follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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MULTIPL SCLEROSİS
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval Training in people with MULTIPL SCLEROSİS, run by Hacettepe 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 6 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İSMAİL KARA, MSc (+90 553 525 8700, ismailkaraa46@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Walking Distance (time frame: Assessed at baseline (pre-intervention), immediately post-intervention (at 8 weeks), and 4 weeks post-intervention (follow-up)). 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 10 Sep 2026.