Multiple Sclerosis
Conditions
Keywords
Multiple sclerosis, Short sprint interval training
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. 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.
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.
Sponsors
Universidad de León
Hasselt University
University of Leon
El Bierzo Hospital
Sil Multiple Sclerosis Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Symbol Digit Modalities Test Oral Score | 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. |
| Change in Fatigue Severity Scale Score | 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. |
| Change in Timed 25 Foot Walk Time | 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. |
| Change in the Six-Spot Step Test Time | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Handgrip Strength | 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. |
| Change in Lower-limb Muscle Power | 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. |
| Change in Lower-limb endurance and strength | 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. |
| Change in Cardiorespiratory fitness | 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. |
| Change in Plantar flexor strength-endurance | 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. |
Countries
Spain
Contacts
CONTACTDaniel Alexandre Boullosa Álvarez
Outcome results
None listed