Multiple SclerosisHIIT-MSNCT07578740
The Effects of High-Intensity Interval Training on Gait, Balance, and Cognitive Functions in Individuals With Multiple Sclerosis
A study testing Moderate-Intensity Continuous Training (MICT) and High-Intensity Interval Training (HIIT) in people with Multiple Sclerosis and High-intensity Interval Training, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to comparatively investigate the effects of low-volume High-Intensity Interval Training (HIIT) versus Moderate-Intensity Continuous Training (MICT) on gait, balance, cognitive functions, and neurovascular biomarkers (BDNF, VEGF) in individuals with Multiple Sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, High-intensity Interval Training, Gait
- What is being tested?
- Moderate-Intensity Continuous Training (MICT) and High-Intensity Interval Training (HIIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2026to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Multiple Sclerosis by a neurologist (Hacettepe University Hospitals, Neurology Outpatient Clinic)
- Age 18 years and older
- EDSS score between 0 and 4
- Score of 24 or above on the Standardized Mini Mental State Examination
- No relapse in the past 3 months
- Medically stable for at least 6 months
Who cannot join
- Any additional cardiopulmonary, neurological, or systemic disease other than MS
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
Hacettepe University
Ankara
Kübra Turan, +90 506 516 41 58, kubraaturann5@gmail.com
About this study
Official title: Investigating the Effects of High-Intensity Interval Training on Gait, Balance, and Cognition in Individuals With Multiple Sclerosis
This study aims to comparatively investigate the effects of low-volume High-Intensity Interval Training (HIIT) versus Moderate-Intensity Continuous Training (MICT) on gait, balance, cognitive functions, and neurovascular biomarkers (BDNF, VEGF) in individuals with Multiple Sclerosis (MS). This randomized controlled trial will be conducted at Hacettepe University, Faculty of Physical Therapy and Rehabilitation.
Read the detailed description
Individuals with MS aged 18 and older, with an EDSS score of 0-4, no relapse in the past three months, and medically stable condition will be randomized into two groups using a sealed-envelope method. Group 1 will receive MICT on a cycle ergometer (twice weekly, 8 weeks); Group 2 will receive low-volume HIIT with the same frequency. Both groups will receive an individualized physiotherapy program after each aerobic session. Outcomes include gait (TUG, T25FW, DGI), balance (Mini-BESTest, mCTSIB), cognitive function (BICAMS: SDMT, CVLT-II, BVMT-R), exercise capacity (ISWT), and blood biomarkers (BDNF, VEGF) assessed via ELISA.
- Conditions
- Multiple Sclerosis, High-intensity Interval Training, Gait, Balance, Cognition, Biomarkers
- Being tested
- Moderate-Intensity Continuous Training (MICT), High-Intensity Interval Training (HIIT)
- Keywords
- Multiple Sclerosis, High-Intensity Interval Training, HIIT, Gait, Balance, Cognition, BDNF, VEGF, Randomized Controlled Trial
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-Intensity Continuous Training (MICT)Behavioural
Cycle ergometer-based exercise, twice weekly for 8 weeks. Starting intensity at 60% of peak workload, progressing to 80%. Each session includes 5-min warm-up, 20-30 min continuous exercise, and 5-min cool-down, followed by 30-min individualized physiotherapy program.
High-Intensity Interval Training (HIIT)Behavioural
Cycle ergometer-based exercise, twice weekly for 8 weeks. Each session includes 5-min warm-up (40% peak workload), 10 × 1-min intervals at 90% peak workload with 1-min active recovery (60% peak workload) between each interval, and 5-min cool-down. Total aerobic exercise duration: ~20 min, followed by 30-min individualized physiotherapy program.
| Study group | Role | What they receive |
|---|---|---|
| MICT Group (Moderate-Intensity Continuous Training) | Active comparator | Cycle ergometer-based MICT, twice weekly for 8 weeks, starting at 60% of peak workload, progressing to 80%. Sessions include 5-min warm-up, 20-30 min exercise, 5-min cool-down, followed by 30-min individualized physiotherapy. Receives: Behavioral: Moderate-Intensity Continuous Training (MICT) |
| HIIT Group (High-Intensity Interval Training) | Experimental | HIIT on cycle ergometer, twice weekly for 8 weeks. Protocol: 5-min warm-up (40% peak workload), 10 × 1-min intervals at 90% peak workload with 1-min active recovery (60% peak workload) between each, followed by 5-min cool-down. Total session: ~20 min aerobic + 30-min individualized physiotherapy. Receives: Behavioral: High-Intensity Interval Training (HIIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go Test (TUG)
Timed Up and Go Test (TUG). Participants are asked to rise from a standard chair, walk 3 meters, turn around, walk back, and sit down as fast as safely possible. Measured in seconds. Lower values indicate better functional mobility and balance.
Measured: Baseline and 8 weeks
Secondary outcomes (10)
Timed 25-Foot Walk Test (T25FW)
Timed 25-Foot Walk Test (T25FW). Participants are instructed to walk 7.62 meters (25 feet) as quickly and safely as possible. Measured in seconds. Lower values indicate better walking speed.
Measured: Baseline and 8 weeks
Dynamic Gait Index (DGI)
Dynamic Gait Index (DGI). Assesses the ability to maintain balance while walking under varied conditions across 8 tasks. Minimum score: 0, Maximum score: 24. Higher scores indicate better dynamic gait balance.
Measured: Baseline and 8 weeks
Incremental Shuttle Walk Test (ISWT)
Incremental Shuttle Walk Test (ISWT). Participants walk between two cones placed 9 meters apart at increasing speeds guided by audio signals until they can no longer maintain the required pace. Measured in meters walked. Higher values indicate better functional exercise capacity.
Measured: Baseline and 8 weeks
Mini Balance Evaluation Systems Test (Mini-BESTest)
Mini Balance Evaluation Systems Test (Mini BESTest). Assesses dynamic balance across 14 items in 4 subsections: anticipatory postural control, reactive postural control, sensory orientation, and dynamic gait. Minimum score: 0, Maximum score: 28. Higher scores indicate better balance performance.
Measured: Baseline and 8 weeks
Modified CTSIB (mCTSIB) - Static Posturography
Modified Clinical Test of Sensory Interaction and Balance (mCTSIB). Assesses static postural stability under 4 conditions: eyes open/closed on firm and foam surfaces. Postural sway is measured in degrees per second. Lower values indicate better static balance.
Measured: Baseline and 8 weeks
Serum BDNF levels (ELISA)
Measured: Baseline and 8 weeks
Serum VEGF levels (ELISA)
Measured: Baseline and 8 weeks
Symbol Digit Modalities Test (SDMT)
Part of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery. Assesses information processing speed in neurological conditions. Participants are asked to match symbols with corresponding digits within 90 seconds. Minimum score: 0, Maximum score: 110. Higher scores indicate better cognitive processing speed.
Measured: Baseline and 8 weeks
California Verbal Learning Test-II (CVLT-II)
Part of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery. Assesses auditory and verbal memory. A list of 16 words across 4 categories is read aloud and recalled over 5 trials. Minimum score: 0, Maximum score: 80. Higher scores indicate better verbal learning and memory.
Measured: Baseline and 8 weeks
Brief Visuospatial Memory Test-Revised (BVMT-R)
Part of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery. Assesses visuospatial memory. Six geometric figures are presented and participants are asked to reproduce them from memory. Minimum score: 0, Maximum score: 36. Higher scores indicate better visuospatial memory.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Turan, Hacettepe University
- Investigators
- Yeliz SALCI, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578740
- Sponsor's protocol ID
- FTREK26/19
- Acronym
- HIIT-MS
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 23 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of High-Intensity Interval Training on Gait, Balance, and Cognition in Individuals With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07578740
- Acronym / sponsor ID
- HIIT-MS / FTREK26/19
- Conditions
- Multiple Sclerosis, High-intensity Interval Training, Gait, Balance, Cognition, Biomarkers
- Keywords
- Multiple Sclerosis, High-Intensity Interval Training, HIIT, Gait, Balance, Cognition, BDNF, VEGF, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 11 May 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.
This study aims to comparatively investigate the effects of low-volume High-Intensity Interval Training (HIIT) versus Moderate-Intensity Continuous Training (MICT) on gait, balance, cognitive functions, and neurovascular biomarkers (BDNF, VEGF) in individuals with Multiple Sclerosis (MS). This randomized controlled trial will be conducted at Hacettepe University, Faculty of Physical Therapy and Rehabilitation.
Detailed description
Individuals with MS aged 18 and older, with an EDSS score of 0-4, no relapse in the past three months, and medically stable condition will be randomized into two groups using a sealed-envelope method. Group 1 will receive MICT on a cycle ergometer (twice weekly, 8 weeks); Group 2 will receive low-volume HIIT with the same frequency. Both groups will receive an individualized physiotherapy program after each aerobic session. Outcomes include gait (TUG, T25FW, DGI), balance (Mini-BESTest, mCTSIB), cognitive function (BICAMS: SDMT, CVLT-II, BVMT-R), exercise capacity (ISWT), and blood biomarkers (BDNF, VEGF) assessed via ELISA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MICT Group (Moderate-Intensity Continuous Training) | Active comparator | Behavioral: Moderate-Intensity Continuous Training (MICT)Cycle ergometer-based MICT, twice weekly for 8 weeks, starting at 60% of peak workload, progressing to 80%. Sessions include 5-min warm-up, 20-30 min exercise, 5-min cool-down, followed by 30-min individualized physiotherapy. |
| HIIT Group (High-Intensity Interval Training) | Experimental | Behavioral: High-Intensity Interval Training (HIIT)HIIT on cycle ergometer, twice weekly for 8 weeks. Protocol: 5-min warm-up (40% peak workload), 10 × 1-min intervals at 90% peak workload with 1-min active recovery (60% peak workload) between each, followed by 5-min cool-down. Total session: ~20 min aerobic + 30-min individualized physiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with Multiple Sclerosis by a neurologist (Hacettepe University Hospitals, Neurology Outpatient Clinic)
- Age 18 years and older
- EDSS score between 0 and 4
- Score of 24 or above on the Standardized Mini Mental State Examination
- No relapse in the past 3 months
Key exclusion criteria (1 listed)
- Any additional cardiopulmonary, neurological, or systemic disease other than MS
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 |
|---|---|---|
| Moderate-Intensity Continuous Training (MICT)Cycle ergometer-based exercise, twice weekly for 8 weeks. Starting intensity at 60% of peak workload, progressing to 80%. Each session includes 5-min warm-up, 20-30 min continuous exercise, and 5-min cool-down, followed by 30-min individualized physiotherapy program. | Behavioural | MICT Group (Moderate-Intensity Continuous Training) |
| High-Intensity Interval Training (HIIT)Cycle ergometer-based exercise, twice weekly for 8 weeks. Each session includes 5-min warm-up (40% peak workload), 10 × 1-min intervals at 90% peak workload with 1-min active recovery (60% peak workload) between each interval, and 5-min cool-down. Total aerobic exercise duration: ~20 min, followed by 30-min individualized physiotherapy program. | Behavioural | HIIT Group (High-Intensity Interval Training) |
Primary outcome
Timed Up and Go Test (TUG)
Time frame: Baseline and 8 weeks
Timed Up and Go Test (TUG). Participants are asked to rise from a standard chair, walk 3 meters, turn around, walk back, and sit down as fast as safely possible. Measured in seconds. Lower values indicate better functional mobility and balance.
10 secondary outcomes
Timed 25-Foot Walk Test (T25FW)
Time frame: Baseline and 8 weeks
Dynamic Gait Index (DGI)
Time frame: Baseline and 8 weeks
Incremental Shuttle Walk Test (ISWT)
Time frame: Baseline and 8 weeks
Mini Balance Evaluation Systems Test (Mini-BESTest)
Time frame: Baseline and 8 weeks
Modified CTSIB (mCTSIB) - Static Posturography
Time frame: Baseline and 8 weeks
Serum BDNF levels (ELISA)
Time frame: Baseline and 8 weeks
Serum VEGF levels (ELISA)
Time frame: Baseline and 8 weeks
Symbol Digit Modalities Test (SDMT)
Time frame: Baseline and 8 weeks
California Verbal Learning Test-II (CVLT-II)
Time frame: Baseline and 8 weeks
Brief Visuospatial Memory Test-Revised (BVMT-R)
Time frame: Baseline and 8 weeks
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 23 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Yeliz SALCI principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-Intensity Continuous Training (MICT) and High-Intensity Interval Training (HIIT) in people with Multiple Sclerosis and High-intensity Interval Training, 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 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: opening soon, as of the sponsor's last update on 23 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 Kübra Turan, Msc, PT (+90 506 516 41 58, kubraaturann5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go Test (TUG) (time frame: Baseline and 8 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 23 Sep 2026.