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CompletedNCT07804264sSIT-MSUpdated Oct 29, 2026

Short Sprint Interval Training in People With Multiple Sclerosis

An interventional study of Short sprint interval training in Multiple Sclerosis, sponsored by Universidad de León. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Universidad de León · Not applicable, Interventional, and Supportive care

Updated Oct 29, 2026Now CompletedEnrollment updated+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The goal of this clinical trial is to learn whether a short sprint interval training protocol on a cycle ergometer can improve physical function, walking, muscle strength, exercise capacity, fatigue, cognitive processing speed, and patient-reported outcomes in people with multiple sclerosis.

The main questions it aims to answer are:

  1. Does short sprint interval training improve walking performance, lower-limb coordination, muscle strength, exercise capacity, fatigue, and cognitive processing speed in people with multiple sclerosis?
  2. How do participants respond to short sprint interval training in terms of heart rate, power, cadence, perceived exertion, and affective valence?
  3. What adverse events or unintended effects, if any, occur during the intervention?

Researchers will compare short sprint interval training with usual physical activity to see if this exercise program improves physical, cognitive, and patient-reported outcomes.

Participants will:

  1. Be randomly assigned to either a short sprint interval training group or a usual physical activity group.
  2. Complete assessments before and after the 2-week training period.
  3. Continue their usual physical activity if they are assigned to the control group.
  4. Complete 6 supervised exercise sessions over 2 weeks if they are assigned to the short sprint interval training group.
  5. During each exercise session, perform short 5-second high-intensity cycling sprints on a recumbent cycle ergometer, separated by recovery periods.
  6. Complete walking, strength, stepping, calf endurance, fatigue, and cognitive processing speed assessments.
02

Conditions studied

  • Multiple Sclerosis

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Keywords

  • Multiple sclerosis
  • Short sprint interval training
03

In context

Multiple Sclerosis

3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Universidad de León is the lead sponsor of 26 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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

  • Diagnosis of multiple sclerosis according to the revised McDonald criteria; Expanded Disability Status Scale score 0-3.5.
  • Age 18-65 years.
  • No multiple sclerosis relapse or exacerbation in the previous month.

Exclusion criteria

Exclusion Criteria:

  • Neurological disease other than multiple sclerosis.
  • Cognitive impairment preventing completion of tests or questionnaires.
  • Neurological, orthopedic, or visual impairments affecting gait.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Short Sprint Interval Training Intervention Group

    Other: Short sprint interval training

  • No intervention
    Usual Physical Activity Control Group

    Participants in this arm will not receive any intervention and will be asked to continue their usual physical activity during the 2-week study period.

Interventions

  • OtherShort sprint interval training

    Participants will perform a supervised short sprint interval training program on a recumbent cycle ergometer for 2 weeks, with 3 sessions per week. Each session will include a 5-minute warm-up at an easy intensity, followed by repeated 5-second high-intensity cycling sprints separated by 40 seconds of active recovery. The number of sprints will increase progressively across sessions from 5 to 9, with a reduced number of sprints in the final session.

06

What researchers measure

Primary outcomes

  1. Change in Symbol Digit Modalities Test Oral Score

    Cognitive processing speed will be assessed through the oral version of the Symbol Digit Modalities Test (SDMT). The outcome will be reported as the total number of correct responses. Scores range from 0 to 110, with higher scores indicating better cognitive processing speed. Change from baseline to Week 4 will be evaluated.

    Time frame: Baseline and Week 4

  2. Change in Fatigue Severity Scale Score

    Fatigue severity will be assessed through the Fatigue Severity Scale (FSS). The FSS includes 9 items, each scored from 1, indicating strongly disagree, to 7, indicating strongly agree. The total score is calculated as the mean of the 9 items and ranges from 1 to 7, with higher scores indicating greater fatigue severity. Change from baseline to Week 4 will be evaluated.

    Time frame: Baseline and Week 4

  3. Change in Timed 25 Foot Walk Time

    Walking speed will be assessed through the Timed 25-Foot Walk (T25FW). This test will be performed forwards and backwards, at a comfortable pace and as fast as safely possible, with 2 trials for each condition. Time will be recorded in seconds using a stopwatch. The outcome will be reported as the lowest time recorded for each condition, with lower times indicating a faster walking speed. Change from baseline to Week 4 will be evaluated.

    Time frame: Baseline to Week 4

  4. Change in the Six-Spot Step Test Time

    Dynamic walking performance and lower-limb coordination will be assessed through the Six-Spot Step Test (SSST). The SSST will be performed after a familiarization trial as fast as safely possible for two trials with each leg. Time will be recorded in seconds using a stopwatch, with lower times indicating better lower-limb coordination and walking performance. The outcome will be reported as the lowest time recorded for each leg. Change from baseline to Week 4 will be evaluated.

    Time frame: Baseline and Week 4

Secondary outcomes

  1. Change in Handgrip Strength

    Handgrip strength will be assessed using a hand dynamometer and recorded in kg. The outcome will be the best of 3 trials, with higher scores indicating greater handgrip strength. Change from baseline to Week 4 will be evaluated.

    Time frame: Baseline and Week 4

  2. Change in Lower-limb Muscle Power

    Lower-limb muscle power will be assessed through the 5-repetition Sit-to-Stand test (5-STS) with the time recorded in seconds with a stopwatch. The outcome will be reported as the best of the 2 trials, with lower times indicating greater muscle power. Change from baseline to Week 4 will be evaluated.

    Time frame: Baseline to Week 4

  3. Change in Lower-limb endurance and strength

    Lower-limb endurance and strength will be assessed through the 30-second Sit-to-Stand test (30-STS), with the number of repetitions visually counted. The outcome will be reported as the best of 2 trials, with a higher number of repetitions indicating greater lower-limb endurance and strength. Change from baseline to Week 4 will be evaluated.

    Time frame: Baseline to Week 4

  4. Change in Cardiorespiratory fitness

    Cardiorespiratory fitness will be assessed using the Young Men's Christian Association 3-minute step test (YMCA step test). Heart rate will be assessed with a chest strap heart-rate monitor. The outcome will be recorded as the mean recovery heart rate after 60 s of rest, with lower scores indicating better cardiorespiratory fitness. Change from baseline to Week 4 will be evaluated.

    Time frame: Baseline and Week 4

  5. Change in Plantar flexor strength-endurance

    Plantar flexor strength-endurance will be assessed using the standing single-leg heel-rise test. The outcome will be reported as the number of repetitions visually counted from each leg in 1 trial, with a higher number of repetitions indicating greater plantar flexor endurance capacity. Change from baseline to Week 4 will be evaluated.

    Time frame: Baseline to Week 4

Other outcomes

  1. Cadence during the intervention sessions

    Data will be recorded during each intervention session and will be used as descriptive data. Cadence will be recorded using the potentiometer of the recumbent cycle ergometer by a custom software app in revolutions per minute.

    Time frame: During each sprint interval training session, up to 2 weeks

  2. Heart rate during the intervention sessions

    Data will be recorded during each intervention session and will be used as descriptive data. Heart rate will be recorded using the handheld sensors of the recumbent cycle ergometer by a custom software app in beats per minute.

    Time frame: During each sprint interval training session, up to 2 weeks

  3. Power during intervention sessions

    Data will be recorded during each intervention session and will be used as descriptive data. Power output will be recorded using the potentiometer of the recumbent cycle ergometer by a custom software app in watts.

    Time frame: During each sprint interval training session, up to 2 weeks

  4. Rating of Perceived Exertion After Each Sprint

    Rating of perceived exertion (RPE) will be assessed using the Borg Category-Ratio 10 scale (CR10). Scores range from 0 to 10, with 0 indicating rest and 10 indicating maximal effort. The outcome will be reported as the perceived exertion score recorded after each sprint, with lower scores indicating lower perceived exertion.

    Time frame: After each sprint during each sprint interval training session, up to 2 weeks

  5. Session Rating of Perceived Exertion

    Global session rating of perceived exertion (sRPE) will be assessed after each exercise session using the Borg Category-Ratio 10 scale (CR10). Scores ranges from 0 to 10, with 0 indicating rest and 10 indicating maximal effort. The outcome will be reported as the session perceived exertion score, with lower scores indicating lower perceived exertion.

    Time frame: After each exercise session during the 2-week intervention period

  6. Affective Valence After Each Sprint

    Affective valence will be assessed after every sprint in the short sprint interval training intervention using the Feeling Scale. This scale ranges from -5 to +5, with +5 indicating very good, 0 indicating neutral, and -5 indicating very bad. The outcome will be reported as the affective valence score, with higher scores indicating better affective valence.

    Time frame: After each sprint during each sprint interval training session, up to 2 weeks

  7. Descriptive and anthropometric data

    Height measured in meters.

    Time frame: Baseline

  8. Descriptive and anthropometric data

    Body mass measured in kilograms.

    Time frame: Baseline

  9. Descriptive and anthropometric data

    Body mass index measured through the combination of weight and height reported in kg/m\^2.

    Time frame: Baseline

  10. Descriptive and anthropometric data.

    Waist circumference and Hip circumference will be measured in centimeters.

    Time frame: Baseline

  11. Descriptive and anthropometric data

    Waist circumference and Hip circumference will be combined to report Waist-to-hip ratio as an index.

    Time frame: Baseline

  12. Descriptive and anthropometric data

    Smoking status will be reported by the patient with yes or no.

    Time frame: Baseline

  13. Descriptive and anthropometric data

    Most affected side will be reported by the patient as left, right, or both.

    Time frame: Baseline

  14. Descriptive and anthropometric data.

    Limb dominance will be reported by the patient as left, right, or ambidextrous.

    Time frame: Baseline

  15. Descriptive and anthropometric data.

    Patient-reported walking ability over the previous 2 weeks will be assessed using the 12-Item Multiple Sclerosis Walking Scale (MSWS-12). Items are scored on a Likert scale from 1 to 5, with 1 indicating "Not at all" and 5 indicating "Extremely". Scores range from 12 to 60 and are transformed into a percentage. The outcome will be reported as the percentage, with higher percentages indicating a greater perceived impact of MS on walking.

    Time frame: Baseline

  16. Descriptive and anthropometric data.

    Fatigue over the previous 4 weeks will be assessed using the Modified Fatigue Impact Scale (MFIS). Items are scored on a Likert scale from 0 to 4, with 0 indicating "Never" and 4 indicating "Almost always". Total scores range from 0 to 84. The outcome will be reported as the total score, with higher scores indicating a greater impact of fatigue.

    Time frame: Baseline

07

Study locations

1 site
  • Ule Motion Lab
    Ponferrada, León 24416, Spain
08

References and documents

Publications

  • Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintore M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21. PubMed 29275977 ↗
  • Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022. PubMed 2803071 ↗
  • Tacchino A, Di Giovanni R, Grange E, Spirito MM, Ponzio M, Battaglia MA, Brichetto G, Solaro CM. The administration of the paper and electronic versions of the Manual Ability Measure-36 (MAM-36) and Fatigue Severity Scale (FSS) is equivalent in people with multiple sclerosis. Neurol Sci. 2024 Mar;45(3):1155-1162. doi: 10.1007/s10072-023-07103-1. Epub 2023 Oct 12. PubMed 37828384 ↗
  • Strober LB, Bruce JM, Arnett PA, Alschuler KN, DeLuca J, Chiaravalloti N, Lebkuecher A, Di Benedetto M, Cozart J, Thelen J, Guty E, Roman CAF. Tired of not knowing what that fatigue score means? Normative data of the Modified Fatigue Impact Scale (MFIS). Mult Scler Relat Disord. 2020 Nov;46:102576. doi: 10.1016/j.msard.2020.102576. Epub 2020 Oct 13. PubMed 33296974 ↗
  • Hobart JC, Riazi A, Lamping DL, Fitzpatrick R, Thompson AJ. Measuring the impact of MS on walking ability: the 12-Item MS Walking Scale (MSWS-12). Neurology. 2003 Jan 14;60(1):31-6. doi: 10.1212/wnl.60.1.31. PubMed 12525714 ↗
  • Benedict RH, Amato MP, Boringa J, Brochet B, Foley F, Fredrikson S, Hamalainen P, Hartung H, Krupp L, Penner I, Reder AT, Langdon D. Brief International Cognitive Assessment for MS (BICAMS): international standards for validation. BMC Neurol. 2012 Jul 16;12:55. doi: 10.1186/1471-2377-12-55. PubMed 22799620 ↗
  • Yocum A, McCoy SW, Bjornson KF, Mullens P, Burton GN. Reliability and validity of the standing heel-rise test. Phys Occup Ther Pediatr. 2010 Aug;30(3):190-204. doi: 10.3109/01942631003761380. PubMed 20608857 ↗
  • Callesen J, Richter C, Kristensen C, Sunesen I, Naesby M, Dalgas U, Skjerbaek AG. Test-retest agreement and reliability of the Six Spot Step Test in persons with multiple sclerosis. Mult Scler. 2019 Feb;25(2):286-294. doi: 10.1177/1352458517745725. Epub 2017 Dec 20. PubMed 29260609 ↗
  • Kappos L, Yiu S, Reucassel J, Oh J, Granziera C, Killestein J, Bermel RA, Berge C, Kazlauskaite A, Schneble HM, Dahlke F, Cree BAC. Performance of Composite Endpoints Defining Progression Independent of Relapse Activity in Multiple Sclerosis. Ann Clin Transl Neurol. 2025 Sep;12(9):1805-1812. doi: 10.1002/acn3.70111. Epub 2025 Jul 8. PubMed 40629721 ↗
  • Tulipani LJ, Meyer B, Fox S, Solomon AJ, Mcginnis RS. The Sit-to-Stand Transition as a Biomarker for Impairment: Comparison of Instrumented 30-Second Chair Stand Test and Daily Life Transitions in Multiple Sclerosis. IEEE Trans Neural Syst Rehabil Eng. 2022;30:1213-1222. doi: 10.1109/TNSRE.2022.3169962. Epub 2022 May 16. PubMed 35468063 ↗
  • Seferoglu M, Aksoy MK, Tunc A. Hand Grip Strength as a Predictive Tool for Upper Extremity Functionality, Balance, and Quality of Life in People With Multiple Sclerosis. Int J MS Care. 2024 May 29;26(Q3):134-139. doi: 10.7224/1537-2073.2022-030. eCollection 2024 May. PubMed 38872997 ↗
  • Gervasoni E, Torchio A, Bertoni R, Chieffo R, Rocca MA, Pau M, Cocco E, Morozumi T, Filippi M, Cattaneo D, Rovaris M. Beyond EDSS: multidomain impairments are detectable and associated with walking disorders in low-disabled people with multiple sclerosis. J Neurol. 2025 May 18;272(6):404. doi: 10.1007/s00415-025-13128-7. PubMed 40382461 ↗
  • Dobson R, Giovannoni G. Multiple sclerosis - a review. Eur J Neurol. 2019 Jan;26(1):27-40. doi: 10.1111/ene.13819. Epub 2018 Nov 18. PubMed 30300457 ↗
  • Walton C, King R, Rechtman L, Kaye W, Leray E, Marrie RA, Robertson N, La Rocca N, Uitdehaag B, van der Mei I, Wallin M, Helme A, Angood Napier C, Rijke N, Baneke P. Rising prevalence of multiple sclerosis worldwide: Insights from the Atlas of MS, third edition. Mult Scler. 2020 Dec;26(14):1816-1821. doi: 10.1177/1352458520970841. Epub 2020 Nov 11. PubMed 33174475 ↗
  • Reich DS, Lucchinetti CF, Calabresi PA. Multiple Sclerosis. N Engl J Med. 2018 Jan 11;378(2):169-180. doi: 10.1056/NEJMra1401483. No abstract available. PubMed 29320652 ↗
  • Foster C, Florhaug JA, Franklin J, Gottschall L, Hrovatin LA, Parker S, Doleshal P, Dodge C. A new approach to monitoring exercise training. J Strength Cond Res. 2001 Feb;15(1):109-15. PubMed 11708692 ↗
  • Youssef H, Gonul MN, Sobeeh MG, Akar K, Feys P, Cuypers K, Vural A. Is High-Intensity Interval Training More Effective Than Moderate Continuous Training in Rehabilitation of Multiple Sclerosis: A Comprehensive Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2024 Aug;105(8):1545-1558. doi: 10.1016/j.apmr.2023.12.012. Epub 2024 Jan 8. PubMed 38199581 ↗
  • Ribeiro JA, Schuch FB, Tonello L, Meneghel Vargas KF, Oliveira-Junior SA, Muller PT, Boullosa D. Effectiveness of short sprint interval training in women with major depressive disorder: a proof-of-concept study. Front Psychiatry. 2024 Apr 15;15:1356559. doi: 10.3389/fpsyt.2024.1356559. eCollection 2024. PubMed 38686128 ↗
  • Boullosa D, Dragutinovic B, Feuerbacher JF, Benitez-Flores S, Coyle EF, Schumann M. Effects of short sprint interval training on aerobic and anaerobic indices: A systematic review and meta-analysis. Scand J Med Sci Sports. 2022 May;32(5):810-820. doi: 10.1111/sms.14133. Epub 2022 Feb 11. PubMed 35090181 ↗
  • Martin-Nunez J, de Castro SG, Heredia-Ciuro A, Navas-Otero A, Cabrera-Martos I, Ortiz-Rubio A, Valenza MC. High-Intensity Interval Training Effects on People With Multiple Sclerosis: A Systematic Review and Meta-analyses for Exercise Capacity and Fatigue. Am J Phys Med Rehabil. 2025 Jul 1;104(7):605-612. doi: 10.1097/PHM.0000000000002676. Epub 2024 Dec 3. PubMed 39642350 ↗
  • Gustavsen S, Olsson A, Sondergaard HB, Andresen SR, Sorensen PS, Sellebjerg F, Oturai A. The association of selected multiple sclerosis symptoms with disability and quality of life: a large Danish self-report survey. BMC Neurol. 2021 Aug 16;21(1):317. doi: 10.1186/s12883-021-02344-z. PubMed 34399707 ↗
  • Townsend LK, Islam H, Dunn E, Eys M, Robertson-Wilson J, Hazell TJ. Modified sprint interval training protocols. Part II. Psychological responses. Appl Physiol Nutr Metab. 2017 Apr;42(4):347-353. doi: 10.1139/apnm-2016-0479. Epub 2016 Dec 7. PubMed 28177741 ↗
  • Metcalfe RS, Williams S, Fernandes GS, Astorino TA, Stork MJ, Phillips SM, Niven A, Vollaard NBJ. Affecting Effects on Affect: The Impact of Protocol Permutations on Affective Responses to Sprint Interval Exercise; A Systematic Review and Meta-Analysis of Pooled Individual Participant Data. Front Sports Act Living. 2022 Feb 17;4:815555. doi: 10.3389/fspor.2022.815555. eCollection 2022. PubMed 35252858 ↗
09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Oct 29, 2026
Sponsor
Collaborators removed: University of Leon
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    Recruiting→Completed
    Sponsor Collaborators removed: University of Leon
    + 4 other changes: verification date, date precision, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07804264
Lead sponsor
Universidad de León
Collaborators
Hasselt University, El Bierzo Hospital, Sil Multiple Sclerosis Association
Responsible party
Daniel Boullosa ("Ramón y Cajal" Fellow, Universidad de León) — Principal investigator
First posted
Sep 4, 2026
Start date
Sep 29, 2026
Primary completion
Oct 19, 2026
Completion
Oct 19, 2026
Last update
Oct 29, 2026

Oversight

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

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