Short Sprint Interval Training in People With Multiple Sclerosis
ConditionMultiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversidad de León
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Neurological disease other than multiple sclerosis.
Cognitive impairment preventing completion of tests or questionnaires.
Neurological, orthopedic, or visual impairments affecting gait.
Trial design
Design model
Parallel
Treatments tested in this trial
Short sprint interval training
Other interventionParticipants 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Short Sprint Interval Training Intervention GroupExperimental treatment 1 intervention
Group B: Usual Physical Activity Control GroupNo intervention 0 interventions
Trial outcomes
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 42
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 43
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 44
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 4Secondary 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 42
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 43
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 44
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 4Other 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 weeks2
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 weeks3
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 weeks4
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidad de León
Lead sponsor
Hasselt University
Collaborator
University of Leon
Collaborator
El Bierzo Hospital
Collaborator
Sil Multiple Sclerosis Association
Collaborator
Source ClinicalTrials.gov