Short Sprint Interval Training in People With Multiple Sclerosis (sSIT-MS)

August 31, 2026 updated by: Daniel Boullosa, Universidad de León

Short Sprint Interval Training as an Effective Exercise Strategy for People With Multiple Sclerosis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Daniel Alexandre Boullosa Álvarez
  • Phone Number: 56 +34 987 29 30 00
  • Email: dboua@unileon.es

Study Locations

  • Spain
    • León
      • Ponferrada, León, Spain, 24416
        • Recruiting
        • Ule Motion Lab
        • Contact:
          • Daniel Alexandre Boullosa Álvarez
          • Phone Number: 56 +34 987 29 30 00
          • Email: dboua@unileon.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Short Sprint Interval Training Intervention Group
Other: Short 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Symbol Digit Modalities Test Oral Score
Time Frame: Baseline and Week 4
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
Time Frame: Baseline and Week 4
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
Time Frame: Baseline to Week 4
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
Time Frame: Baseline and Week 4
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Handgrip Strength
Time Frame: Baseline and Week 4
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.
Baseline and Week 4
Change in Lower-limb Muscle Power
Time Frame: Baseline to Week 4
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.
Baseline to Week 4
Change in Lower-limb endurance and strength
Time Frame: Baseline to Week 4
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.
Baseline to Week 4
Change in Cardiorespiratory fitness
Time Frame: Baseline and Week 4
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.
Baseline and Week 4
Change in Plantar flexor strength-endurance
Time Frame: Baseline to Week 4
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.
Baseline to Week 4

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cadence during the intervention sessions
Time Frame: During each sprint interval training session, up to 2 weeks

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.
During each sprint interval training session, up to 2 weeks
Heart rate during the intervention sessions
Time Frame: During each sprint interval training session, up to 2 weeks

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.
During each sprint interval training session, up to 2 weeks
Power during intervention sessions
Time Frame: During each sprint interval training session, up to 2 weeks

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.
During each sprint interval training session, up to 2 weeks
Rating of Perceived Exertion After Each Sprint
Time Frame: After each sprint during each sprint interval training session, up to 2 weeks
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.
After each sprint during each sprint interval training session, up to 2 weeks
Session Rating of Perceived Exertion
Time Frame: After each exercise session during the 2-week intervention period
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.
After each exercise session during the 2-week intervention period
Affective Valence After Each Sprint
Time Frame: After each sprint during each sprint interval training session, up to 2 weeks
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.
After each sprint during each sprint interval training session, up to 2 weeks
Descriptive and anthropometric data
Time Frame: Baseline
Height measured in meters.
Baseline
Descriptive and anthropometric data
Time Frame: Baseline
Body mass measured in kilograms.
Baseline
Descriptive and anthropometric data
Time Frame: Baseline
Body mass index measured through the combination of weight and height reported in kg/m^2.
Baseline
Descriptive and anthropometric data.
Time Frame: Baseline
Waist circumference and Hip circumference will be measured in centimeters.
Baseline
Descriptive and anthropometric data
Time Frame: Baseline
Waist circumference and Hip circumference will be combined to report Waist-to-hip ratio as an index.
Baseline
Descriptive and anthropometric data
Time Frame: Baseline
Smoking status will be reported by the patient with yes or no.
Baseline
Descriptive and anthropometric data
Time Frame: Baseline
Most affected side will be reported by the patient as left, right, or both.
Baseline
Descriptive and anthropometric data.
Time Frame: Baseline
Limb dominance will be reported by the patient as left, right, or ambidextrous.
Baseline
Descriptive and anthropometric data.
Time Frame: Baseline
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.
Baseline
Descriptive and anthropometric data.
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de León

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hasselt University
University of Leon
El Bierzo Hospital
Sil Multiple Sclerosis Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20633
  • RYC2021-031098-I (Other Grant/Funding Number: State Research Agency / Ministry of Science, Innovation and Universities)
  • ULE-13-B (Other Grant/Funding Number: Regional Government of Castile and León / European Social Fund Plus (ESF+) 2021-2027)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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