NCT07804264

Brief 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. 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. 2.How do participants respond to short sprint interval training in terms of heart rate, power, cadence, perceived exertion, and affective valence?
  3. 3.What adverse events or unintended effects, if any, occur during the intervention?
  4. 4.Be randomly assigned to either a short sprint interval training group or a usual physical activity group.
  5. 5.Complete assessments before and after the 2-week training period.
  6. 6.Continue their usual physical activity if they are assigned to the control group.
  7. 7.Complete 6 supervised exercise sessions over 2 weeks if they are assigned to the short sprint interval training group.
  8. 8.During each exercise session, perform short 5-second high-intensity cycling sprints on a recumbent cycle ergometer, separated by recovery periods.
  9. 9.Complete walking, strength, stepping, calf endurance, fatigue, and cognitive processing speed assessments.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Sep 2026

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2026

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Completed
Last Updated

September 4, 2026

Status Verified

August 1, 2026

Enrollment Period

1 month

First QC Date

July 3, 2026

Last Update Submit

August 31, 2026

Conditions

Keywords

Multiple sclerosisShort sprint interval training

Outcome Measures

Primary Outcomes (4)

  • 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.

    Baseline and Week 4

  • 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.

    Baseline and Week 4

  • 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.

    Baseline to Week 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.

    Baseline and Week 4

Secondary Outcomes (5)

  • Change in Handgrip Strength

    Baseline and Week 4

  • Change in Lower-limb Muscle Power

    Baseline to Week 4

  • Change in Lower-limb endurance and strength

    Baseline to Week 4

  • Change in Cardiorespiratory fitness

    Baseline and Week 4

  • Change in Plantar flexor strength-endurance

    Baseline to Week 4

Other Outcomes (16)

  • Cadence during the intervention sessions

    During each sprint interval training session, up to 2 weeks

  • Heart rate during the intervention sessions

    During each sprint interval training session, up to 2 weeks

  • Power during intervention sessions

    During each sprint interval training session, up to 2 weeks

  • +13 more other outcomes

Study Arms (2)

Short Sprint Interval Training Intervention Group

EXPERIMENTAL
Other: Short sprint interval training

Usual Physical Activity Control Group

NO INTERVENTION

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

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.

Short Sprint Interval Training Intervention Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ule Motion Lab

Ponferrada, León, 24416, Spain

RECRUITING

Related Publications (23)

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  • 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.

    PMID: 12525714BACKGROUND
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    PMID: 22799620BACKGROUND
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    PMID: 20608857BACKGROUND
  • 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.

    PMID: 29260609BACKGROUND
  • 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.

    PMID: 40629721BACKGROUND
  • 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.

    PMID: 35468063BACKGROUND
  • 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.

    PMID: 38872997BACKGROUND
  • 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.

    PMID: 40382461BACKGROUND
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    PMID: 30300457BACKGROUND
  • 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.

    PMID: 33174475BACKGROUND
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    PMID: 29320652BACKGROUND
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    PMID: 11708692BACKGROUND
  • 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.

    PMID: 38199581BACKGROUND
  • 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.

    PMID: 38686128BACKGROUND
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    PMID: 35090181BACKGROUND
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    PMID: 34399707BACKGROUND
  • 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.

    PMID: 28177741BACKGROUND
  • 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.

    PMID: 35252858BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Daniel Alexandre Boullosa Álvarez

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
"Ramón y Cajal" Fellow

Study Record Dates

First Submitted

July 3, 2026

First Posted

September 4, 2026

Study Start

September 1, 2026

Primary Completion

October 1, 2026

Study Completion

October 1, 2026

Last Updated

September 4, 2026

Record last verified: 2026-08

Locations