ClinicalTrials.gg
RecruitingNCT07771868Updated Sep 10, 2026

High-Intensity Interval Training for Walking and Function Across Different Multiple Sclerosis Disability Levels

An interventional study of High-Intensity Interval Training in MULTIPL SCLEROSİS, sponsored by Hacettepe University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 23 studies in Multiple Sclerosis by Hacettepe University — 6 open to participants now, 6 under way, none of them phase 3. Multiple Sclerosis · Hacettepe University.

Planned enrollment
10th of 15
30 · median 34
Started
2026
with 4 others
No phase
15 of 23
4 open now
Registered
21st of 23
by date

Among the 23 studies in Multiple Sclerosis by Hacettepe University, this one is the 10th largest by planned enrollment of the 15 interventional ones that give a count, is one of 5 that started in 2026, is one of 15 with no phase, and was the 21st registered.

Multiple Sclerosis

3,267 studies on the registry are indexed under Multiple Sclerosis; 662 are open to participants now.

Browse Multiple Sclerosis studies →

Open to participants now

6 of the 23 studies in Multiple Sclerosis by Hacettepe University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 6 open studies →

Where they have run

Who these studies take

Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 23 studies in Multiple Sclerosis by Hacettepe University, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • MULTIPL SCLEROSİS

Browse trials for

Keywords

  • Multiple Sclerosis
  • High-Intensity Interval Training
  • Cycle Ergometer
  • Expanded Disability Status Scale
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 score of ≥24.

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Mild Disability Group (EDSS 0 to <=2.5)

    Behavioral: High-Intensity Interval Training

  • Experimental
    Moderate Disability Group (EDSS 3.0 to <=4.5)

    Behavioral: High-Intensity Interval Training

  • Experimental
    Severe Disability Group (EDSS 5.0 to <=6.5)

    Behavioral: High-Intensity Interval Training

Interventions

  • BehavioralHigh-Intensity Interval Training

    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.

06

What researchers measure

Primary outcomes

  1. Maximum Walking Distance

    Maximum walking distance (in meters) will be objectively estimated using a predictive model previously developed by our research team.

    Time frame: Assessed at baseline (pre-intervention), immediately post-intervention (at 8 weeks), and 4 weeks post-intervention (follow-up)

Secondary outcomes

  1. 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.

    Time frame: Baseline, immediately post-intervention, and 4 weeks follow-up

  2. 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.

    Time frame: Baseline, immediately post-intervention, and 4 weeks follow-up

  3. Muscular Endurance

    It will be evaluated through repetitive muscle contraction tests.

    Time frame: Baseline, immediately post-intervention, and 4 weeks follow-up

  4. 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.

    Time frame: Baseline, immediately post-intervention, and 4 weeks follow-up

  5. 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").

    Time frame: Baseline, immediately post-intervention, and 4 weeks follow-up

  6. 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.

    Time frame: Baseline, immediately post-intervention, and 4 weeks follow-up

  7. 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.

    Time frame: Baseline, immediately post-intervention, and 4 weeks follow-up

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Dec 2027, 15 months after the start.

Of 848 non-industry interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 15 months is below that.

Counting every sponsor, half of 870 studies reached it within 21 months; a quarter within 9 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 4, 2026
First posted
Aug 18, 2026
StartActual
Sep 1, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Jan 31, 2028
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07771868
Responsible party
ISMAIL KARA (Research Assistant, Hacettepe University) — Principal investigator
First posted
Aug 18, 2026
Start date
Sep 1, 2026
Primary completion
Dec 31, 2027 (estimated)
Completion
Jan 31, 2028 (estimated)
Last update
Sep 10, 2026

Study contacts

İSMAİL KARA, MSc
Contact
ismailkaraa46@gmail.com
+90 553 525 8700

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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