MULTIPL SCLEROSİS
Conditions
Keywords
Multiple Sclerosis, High-Intensity Interval Training, Cycle Ergometer, Expanded Disability Status Scale
Brief summary
Multiple Sclerosis (MS) is a chronic neurological disease that can affect daily functioning, mobility, and overall quality of life. High-Intensity Interval Training (HIIT) is known to be a time-efficient exercise approach that improves exercise capacity and reduces fatigue in MS. However, current research lacks sufficient data on how HIIT affects individuals with different levels of disability. The main purpose of this study is to evaluate the effects of a stationary bicycle-based HIIT protocol on maximum walking distance, fatigue, balance, muscle strength, endurance, gait speed, and quality of life in MS patients across three different disability levels: mild, moderate, and severe (classified according to Expanded Disability Status Scale - EDSS scores). Participants will complete a cycle ergometer-based HIIT program. Assessments will be conducted at three time points: Before starting the exercise program (baseline) Immediately after completing the program (post-treatment) 4 weeks after the completion of the program (follow-up) To ensure unbiased results, a triple-blind design will be used, meaning the outcome assessor, the treating physiotherapist, and the data analyst will be blinded to group assignments. The findings aim to help clinicians tailor personalized, effective HIIT protocols based on a patient's specific disability level rather than using a standardized, one-size-fits-all approach in MS rehabilitation.
Interventions
BEHAVIORALHigh-Intensity Interval Training
All exercise sessions in our study will be conducted using a bicycle ergometer (Monark Cardio Care 827 X, Monark Exercise AB, Sweden). The HIIT protocol will consist of five 3-minute high-intensity intervals performed at 80-100 revolutions per minute, corresponding to 85-90% of maximum heart rate. Between these intervals, active rest periods will be implemented, during which cadence is reduced to 50-60 revolutions per minute for 1.5 minutes to lower heart rate to 50-60% of maximum heart rate. The total training duration is planned to be 20 minutes, consisting of a 2-minute warm-up at the beginning and a 2-minute cool-down at the end. Sessions will be conducted three times a week. The total treatment duration is planned to be 8 weeks.
Sponsors
Hacettepe University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Be between the ages of 18 and 65, * Have been diagnosed with MS by a treating physician, * Have an EDSS score between 0 and 6.5, * Not having experienced a relapse within the last 3 months, * Not having severe lower extremity contractures, severe spasticity (≥3 on the Modified Ashworth Scale), or an acute orthopedic problem that would prevent the participant from pedaling on a bicycle ergometer, * Having a Mini Mental State Examination score of ≥24.
Exclusion criteria
* Having a severe cardiovascular, orthopedic, respiratory, or metabolic disease, * Having an additional neurological condition, * Being pregnant or suspecting pregnancy, * Having received a botulinum toxin injection within the last 3 months, * Having a COMPASS-31 total score greater than 13.6
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Walking Distance | Assessed at baseline (pre-intervention), immediately post-intervention (at 8 weeks), and 4 weeks post-intervention (follow-up) | Maximum walking distance (in meters) will be objectively estimated using a predictive model previously developed by our research team. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | Baseline, immediately post-intervention, and 4 weeks follow-up | Fatigue will be evaluated with the Fatigue Severity Scale. This scale also assesses the fatigue severity of patients through 9 questions. Each question has a score ranging from 1 (strongly disagree) to 7 (strongly agree). The fatigue severity scale score is determined by calculating the average value of the responses given to these 9 questions. A higher score indicates greater fatigue severity. |
| Muscle Strength | Baseline, immediately post-intervention, and 4 weeks follow-up | It will be evaluated using a hand-held dynamometer. In this test, which will be performed in a long-sitting position with the hips in 90 degrees of flexion and the knees in extension, the measuring device (Lafayette Instrument Company, Lafayette IN, USA) will be placed on the sole of the foot. The patient will then be asked to press their foot downward, and the result will be recorded. |
| Muscular Endurance | Baseline, immediately post-intervention, and 4 weeks follow-up | It will be evaluated through repetitive muscle contraction tests. |
| Gait Speed | Baseline, immediately post-intervention, and 4 weeks follow-up | The walking speeds of the participants will be evaluated using the 10-Meter Walk Test, whose validity and reliability have been proven in clinical studies. During the assessment, participants will be asked to walk along a 10-meter straight and obstacle-free corridor at their normal pace, and the elapsed time will be recorded using a stopwatch. |
| Health-Related Quality of Life | Baseline, immediately post-intervention, and 4 weeks follow-up | It will be evaluated using the Multiple Sclerosis Impact Scale-29. The questionnaire assesses the impact of MS on daily life over the past two weeks. Responses are recorded on a 5-point Likert scale ranging from 1 ("not at all") to 5 ("extremely"). |
| balance | Baseline, immediately post-intervention, and 4 weeks follow-up | Objective balance assessments of the participants will be performed using the TecnoBody PK200 Balance Device. As part of the assessment protocol, patients will sequentially undergo stabilometric static balance, the Romberg test in eyes-open and eyes-closed positions, single-leg stance on the right and left, and dynamic balance tests. |
| Dynamic Balance | Baseline, immediately post-intervention, and 4 weeks follow-up | It will be evaluated using the Community Balance and Mobility Scale. This scale evaluates balance and mobility status across 13 tasks that involve advanced functional balance and mobility activities. Each item is scored between 0 and 5 (0 = unable to perform, 5 = able to perform independently). Item 12 is scored from 0 to 6, with an additional point added if a basket is carried while descending the stairs. Higher scores indicate better balance and mobility. |
Countries
Turkey (Türkiye)
Contacts
CONTACTİSMAİL KARA, MSc
Outcome results
None listed