Multiple SclerosisPwMSNCT06676618
Effect of Multimodal Exercise Training in Patients With Multiple Sclerosis
A study testing Multimodal Exercise Training in people with Multiple Sclerosis, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).
Trial summary
The study aims to examine the effects of multimodal exercise training including aerobic, strengthening and balance exercises via face-to-face and asynchronous video-based telerehabilitation on disease activity, disability level, aerobic capacity, physical activity level, balance, fatigue level and quality of life in… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Multimodal Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Feb 2025to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with multiple sclerosis by a neurologist
- Volunteering to participate in the study
- Being ambulatory
- EDSS between 3.0-5.5
- Being literate
- Having internet access
- Not having participated in a standardized physiotherapy and rehabilitation program in the last 3 months
Who cannot join
- Having an orthopedic problem affecting its mobility
- Having psychiatric problems, severe cognitive impairment, or epilepsy in addition to the MS diagnosis
- Blurred vision or visual impairment
- Pregnancy
- Having had an attack or received corticosteroid treatment 3 months before participating in the study
- Having a disease affecting immunological parameters (infection, cancer, etc.)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Not yet recruiting
Istanbul University-Cerrahpasa
Istanbul, Buyukcekmece, 34500
Pelin Vural, +905344245350, pelinvural7@gmail.com
Yonca Zenginler Yazgan, PhD
- Recruiting
Istanbul University-Cerrahpasa
Istanbul, Istanbul, 34810
Pelin Vural, 905344245350, pelinvural7@gmail.com
About this study
Official title: Effect of Multimodal Exercise Training on Disease Activity and Functional Status in Patients With Multiple Sclerosis
The study aims to examine the effects of multimodal exercise training including aerobic, strengthening and balance exercises via face-to-face and asynchronous video-based telerehabilitation on disease activity, disability level, aerobic capacity, physical activity level, balance, fatigue level and quality of life in individuals with multiple sclerosis. Therefore, this study consists of two hypotheses.
Hypotheses:
H0: Multimodal exercise training has no effect on disease activity and functional status in patients with multiple sclerosis H1: Multimodal exercise training has effects on disease activity and functional status in patients with multiple sclerosis
Read the detailed description
Multiple sclerosis (MS) is a leading cause of disability in young adults, with symptoms varying based on lesion size, location, and disease course. These symptoms often worsen over time, significantly impacting quality of life. To manage symptoms and potentially affect disease activity, patients are often directed to exercise interventions, though the impact on disease progression is still being studied. Neuroimaging, particularly magnetic resonance imaging (MRI), is commonly used to monitor MS, but MRI does not reveal brain activation levels, which is why functional MRI is recommended for a more detailed evaluation. Exercise, both face-to-face and telerehabilitation (TR), is considered an effective treatment for MS. Studies show that TR increases patient adherence and can be as effective as in-person therapy. Our study aims to assess the effects of a multimodal exercise program combining face-to-face and TR on disease activity and functional status in patients with MS (PwMS). PwMS with an Expanded Disability Status Scale (EDSS) score of 3.0 to 5.5 will be randomly assigned to either the multimodal exercise training group (Group I) or a control group (Group II). Disease activity, disability, aerobic capacity, physical activity, balance, fatigue, and quality of life will be evaluated. Group I will participate in exercise training three days a week (one day in-person, two days TR) for 12 weeks. Group II will receive no exercise during this period and will be reassessed after 12 weeks.
- Conditions
- Multiple Sclerosis
- Being tested
- Multimodal Exercise Training, Control Group
- Keywords
- Exercise, Physiotherapy, Degenerative diseases, Disease activity, Multimodal
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Exercise TrainingOther
The exercise training consisting of aerobic, strengthening and balance exercises will be applied for 12 weeks/3days for 1hour. One day of the exercise training will be performed in a clinical environment with a physiotherapist, and the other 2 days of the week, participants will be asked to apply asynchronous video-based telerehabilitation over the internet in their own homes. The asynchronous video-based telerehabilitation application will be performed through an account created specifically for the participant on the "www.telenororehab.com" website. The exercise program will be created according to the individual's condition and progression will be provided every 3 weeks. Patients who do not attend 3 consecutive sessions will be excluded from the study.
Control GroupOther
Participants in the control group will be placed on the waiting list after all evaluation methods have been applied and will be re-evaluated at the end of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Exercise Training Group | Experimental | Participants in the multimodal exercise training group will be given a treatment protocol consisting of aerobic exercise and strengthening exercises in the presence of a physiotherapist for a total of 12 weeks, 3 days a week for 1 hour. Receives: Other: Multimodal Exercise Training |
| Control Group | Other | Participants in the control group will be put on the waiting list after all assessment methods have been applied and will be re-evaluated at the end of 12 weeks. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple Sclerosis Functional Composite Test (The change between the initial value and the value after 3 months will be evaluated).
The Multiple Sclerosis Functional Composite Test evaluates disease activity through three sections: cognitive status, and upper and lower extremity function. The Paced Auditory Serial Addition Test (PASAT) measures auditory processing speed, attention, flexibility, and calculation by having the patient add numbers presented at three-second intervals. The score is based on correct answers, with a maximum of 60 points. The Timed 25 Foot Walking Test (T25FWT) assesses lower extremity function by recording the time (in seconds) taken to walk 7.62 meters as quickly and safely as possible, with the average of two trials used for scoring. The 9-Hole Peg Test (9DPT) evaluates upper extremity function by having the patient place and remove nine pegs as quickly as possible, with scores based on the average of two trials for each hand.
Measured: Baseline and end of weeks 12
Functional Magnetic Resonance Imaging (fMRI) (The change between the initial value and the value after 3 months will be evaluated).
fMRI is a non-invasive method that allows the examination of central nervous system function and the identification of abnormal activation patterns and/or functional connectivity caused by diseases (Rocca et al 2024).In our study, functional MRI evaluations are planned to be performed using parallel imaging sequences with a 3 T Siemens device with a 32-channel head coil. High-resolution (1 x 1 x 1 mm isotropic) sagittal 190 slices will be obtained with a T1-weighted imaging sequence (TR/TE: 7.7/3.7 ms;, FA: 8°; FOV: 256 x 256). Functional resting state data will be taken with a single-shot echo planar imaging (EPI) sequence consisting of 35 slices of 4 mm thickness, 300 dynamic shots (TR/TE: 2230/30 ms, FA: 77°; matrix: 80x80) and will last approximately 11 minutes. Before functional acquisition, magnetic field maps will be recorded in order to correct signal distortions caused by tissue inhomogeneities in the magnetic field during the analysis phase.
Measured: Baseline and end of weeks 12
Brain-derived neurotrophic factor (BDNF) assessment (The change between the initial value and the value after 3 months will be evaluated).
BDNF is a neurotrophin that affects the survival, growth and function of neurons in the central and peripheral nervous system, provides stabilization of synapses, and regulates synaptic function, axon and dendrite branching. In our study, Enzyme-Linked Immunosorbent Assay (ELISA) will be used to assess the BDNF levels of participants. All participants will be asked not to consume alcohol and caffeine in the last 12 hours before blood collection, not to take any anti-inflammatory drugs other than their routine treatments and not to exercise. The blood samples to be collected will be centrifuged and stored at -80 degrees in Eppendorf or Falcon tubes (15 ml) (Shobeiri et al 2022; Briken et al. 2016). After the treatments are completed, the blood taken will be analyzed by experienced technicians in the laboratory together with the blood taken before exercise training.
Measured: Baseline and end of weeks 12
Secondary outcomes (7)
The Expanded Disability Status Scale (EDSS) (The change between the initial value and the value after 3 months will be evaluated).
EDSS will be used to assess the disability level of the participants. The scale widely used to assess the level of disability in PwMS, evaluates 8 functional subsystems. These systems consist of pyramidal functions, cerebellar functions, brainstem functions, sensory functions, bladder-bowel functions, visual functions, cognitive functions, and other functions. The scale consists of a 20-category ordinal rating system ranging from 0 (normal neurological examination regardless of symptoms) to 10 (death due to MS), with 0.5-point increments starting from 1 (Kurtzke 1983).
Measured: Baseline and end of weeks 12
6 Minute Walk Test (6MWT) (The change between the initial value and the value after 3 months will be evaluated).
It is a simple, practical test applied according to the standard protocol of the American Thoracic Society (ATS) to measure walking capacity. It has been reported that the test is valid and reliable in MS patients with mild and moderate disability. In our study, 6MWT will be performed in accordance with the standards set in the guidelines for MS patients. The participant will be asked to walk as fast as possible at his own walking pace on the 30-meter track for 6 minutes. Before starting the test, participants will be explained that they can rest if they develop excessive fatigue or respiratory distress during the test and that this time is included in the test period. As a result of the test, the distance traveled by the participant will be recorded in meters (Paltamaa et al. 2005; ATS statement 2002).
Measured: Baseline and end of weeks 12
ActiGraph wGT3X-BT (The change between the initial value and the value after 3 months will be evaluated).
Accelerometer is a valid, reliable and objective measurement device that measures the number, intensity and energy consumption of activities. The device can be attached to the wrist and ankle with an elastic belt. In our study, the amount of physical activity and energy consumption of the participants in a week will be assessed using ActiGraph wGT3X-BT Accelerometer (Polhemus et al. 2022).
Measured: Baseline and end of weeks 12
The Godin Leisure-Time Exercise Questionnaire (The change between the initial value and the value after 3 months will be evaluated).
It is a self-reported questionnaire with two questions that measures the physical activity behavior of the participants. In the first question, the frequencies of mild, moderate and intense physical activity performed for more than 15 minutes in a normal week are questioned. Weekly frequencies of light, moderate, and vigorous physical activities are multiplied by 3, 5 and 9 metabolic equivalents, respectively, and the sum of the results is recorded as total leisure activity. Second question seeks the frequency of activity that causes sweating in a normal week is questioned. Less than 14 scores means insufficiently active/sedentary, 14-23 scores means moderately active and 24 scores or more means active. So higher scores better outcomes (Weikert et al. 2010).
Measured: Baseline and end of weeks 12
Balance Assessment (The change between the initial value and the value after 3 months will be evaluated).
Our study will evaluate static and dynamic balance. The One-Legged Standing Test is a reliable test that can be easily applied to evaluate static balance. For this test, the participant will be asked to stand on the right and left feet respectively. As a result of the test, the time the participant can stand on one leg will be recorded in seconds (Fry \& Pfalzer 2006). The Timed Up and Go Test is a test used to evaluate dynamic balance. The test measures the time it takes for a person to get up from a chair, walk 3 meters at a comfortable pace, return to the chair and sit down in seconds. The test starts when the participant gets up from the chair and ends when he/she sits back down on the chair. A shorter time represents better mobility (Cattaneo et al. 2006).
Measured: Baseline and end of weeks 12
Fatigue Severity Scale (The change between the initial value and the value after 3 months will be evaluated).
It is a scale that evaluates the fatigue of MS patients in daily functions. In the evaluation made with 9 questions, each question is scored between 1 (totally disagree) - 7 (totally agree). The result score is the average value of nine questions. High score indicates increased severity of fatigue (Krupp et al. 1989).
Measured: Baseline and end of weeks 12
Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) (The change between the initial value and the value after 3 months will be evaluated).
The scale consists of 31 questions in 6 subgroups including physical condition, symptoms, psychological condition, self, relationship with friends, family and medical personnel. The answers are scored between 0 and 5 and a score ranging from 0 to 100 is obtained. Higher scores indicate higher quality of life (Simeoni et al. 2008).
Measured: Baseline and end of weeks 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start10 Feb 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pelin Vural, Istanbul University - Cerrahpasa
- Investigators
- Pelin Vural, MSc, Principal investigator, Istanbul University-Cerrahpasa Institute of Postgraduate EducationYonca Zenginler Yazgan, PhD, Study chair, Istanbul University-Cerrahpasa Faculty of Health ScienceMurat Kürtüncü, Prof. Dr., Study chair, Istanbul University Istanbul Faculty of Medicine Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676618
- Sponsor's protocol ID
- IU-C20204-161
- Acronym
- PwMS
- Status last verified
- Mar 2026
- First submitted
- 5 Nov 2024
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rocca MA, Romano F, Tedone N, Filippi M. Advanced neuroimaging techniques to explore the effects of motor and cognitive rehabilitation in multiple sclerosis. J Neurol. 2024 Jul;271(7):3806-3848. doi: 10.1007/s00415-024-12395-0. Epub 2024 May 1.
PubMed 38691168Shobeiri P, Karimi A, Momtazmanesh S, Teixeira AL, Teunissen CE, van Wegen EEH, Hirsch MA, Yekaninejad MS, Rezaei N. Exercise-induced increase in blood-based brain-derived neurotrophic factor (BDNF) in people with multiple sclerosis: A systematic review and meta-analysis of exercise intervention trials. PLoS One. 2022 Mar 3;17(3):e0264557. doi: 10.1371/journal.pone.0264557. eCollection 2022.
PubMed 35239684Briken S, Rosenkranz SC, Keminer O, Patra S, Ketels G, Heesen C, Hellweg R, Pless O, Schulz KH, Gold SM. Effects of exercise on Irisin, BDNF and IL-6 serum levels in patients with progressive multiple sclerosis. J Neuroimmunol. 2016 Oct 15;299:53-58. doi: 10.1016/j.jneuroim.2016.08.007. Epub 2016 Aug 5.
PubMed 27725121Cutter GR, Baier ML, Rudick RA, Cookfair DL, Fischer JS, Petkau J, Syndulko K, Weinshenker BG, Antel JP, Confavreux C, Ellison GW, Lublin F, Miller AE, Rao SM, Reingold S, Thompson A, Willoughby E. Development of a multiple sclerosis functional composite as a clinical trial outcome measure. Brain. 1999 May;122 ( Pt 5):871-82. doi: 10.1093/brain/122.5.871.
PubMed 10355672Bosma LV, Kragt JJ, Brieva L, Khaleeli Z, Montalban X, Polman CH, Thompson AJ, Tintore M, Uitdehaag BM. Progression on the Multiple Sclerosis Functional Composite in multiple sclerosis: what is the optimal cut-off for the three components? Mult Scler. 2010 Jul;16(7):862-7. doi: 10.1177/1352458510370464. Epub 2010 May 20.
PubMed 20488826Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.
PubMed 6685237ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
PubMed 12091180Polhemus A, Haag C, Sieber C, Sylvester R, Kool J, Gonzenbach R, von Wyl V. Methodological heterogeneity biases physical activity metrics derived from the Actigraph GT3X in multiple sclerosis: A rapid review and comparative study. Front Rehabil Sci. 2022 Nov 28;3:989658. doi: 10.3389/fresc.2022.989658. eCollection 2022.
PubMed 36518351Weikert M, Motl RW, Suh Y, McAuley E, Wynn D. Accelerometry in persons with multiple sclerosis: measurement of physical activity or walking mobility? J Neurol Sci. 2010 Mar 15;290(1-2):6-11. doi: 10.1016/j.jns.2009.12.021. Epub 2010 Jan 8.
PubMed 20060544Cattaneo D, Regola A, Meotti M. Validity of six balance disorders scales in persons with multiple sclerosis. Disabil Rehabil. 2006 Jun 30;28(12):789-95. doi: 10.1080/09638280500404289.
PubMed 16754576Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.
PubMed 2803071Simeoni M, Auquier P, Fernandez O, Flachenecker P, Stecchi S, Constantinescu C, Idiman E, Boyko A, Beiske A, Vollmer T, Triantafyllou N, O'Connor P, Barak Y, Biermann L, Cristiano E, Atweh S, Patrick D, Robitail S, Ammoury N, Beresniak A, Pelletier J; MusiQol study group. Validation of the Multiple Sclerosis International Quality of Life questionnaire. Mult Scler. 2008 Mar;14(2):219-30. doi: 10.1177/1352458507080733. Epub 2007 Oct 17.
PubMed 17942521
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multimodal Exercise Training on Disease Activity and Functional Status in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06676618
- Acronym / sponsor ID
- PwMS / IU-C20204-161
- Conditions
- Multiple Sclerosis
- Keywords
- Exercise, Physiotherapy, Degenerative diseases, Disease activity, Multimodal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to examine the effects of multimodal exercise training including aerobic, strengthening and balance exercises via face-to-face and asynchronous video-based telerehabilitation on disease activity, disability level, aerobic capacity, physical activity level, balance, fatigue level and quality of life in individuals with multiple sclerosis. Therefore, this study consists of two hypotheses.
Hypotheses:
H0: Multimodal exercise training has no effect on disease activity and functional status in patients with multiple sclerosis H1: Multimodal exercise training has effects on disease activity and functional status in patients with multiple sclerosis
Detailed description
Multiple sclerosis (MS) is a leading cause of disability in young adults, with symptoms varying based on lesion size, location, and disease course. These symptoms often worsen over time, significantly impacting quality of life. To manage symptoms and potentially affect disease activity, patients are often directed to exercise interventions, though the impact on disease progression is still being studied. Neuroimaging, particularly magnetic resonance imaging (MRI), is commonly used to monitor MS, but MRI does not reveal brain activation levels, which is why functional MRI is recommended for a more detailed evaluation. Exercise, both face-to-face and telerehabilitation (TR), is considered an effective treatment for MS. Studies show that TR increases patient adherence and can be as effective as in-person therapy. Our study aims to assess the effects of a multimodal exercise program combining face-to-face and TR on disease activity and functional status in patients with MS (PwMS). PwMS with an Expanded Disability Status Scale (EDSS) score of 3.0 to 5.5 will be randomly assigned to either the multimodal exercise training group (Group I) or a control group (Group II). Disease activity, disability, aerobic capacity, physical activity, balance, fatigue, and quality of life will be evaluated. Group I will participate in exercise training three days a week (one day in-person, two days TR) for 12 weeks. Group II will receive no exercise during this period and will be reassessed after 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal Exercise Training Group | Experimental | Other: Multimodal Exercise TrainingParticipants in the multimodal exercise training group will be given a treatment protocol consisting of aerobic exercise and strengthening exercises in the presence of a physiotherapist for a total of 12 weeks, 3 days a week for 1 hour. |
| Control Group | Other | Other: Control GroupParticipants in the control group will be put on the waiting list after all assessment methods have been applied and will be re-evaluated at the end of 12 weeks. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being diagnosed with multiple sclerosis by a neurologist
- Volunteering to participate in the study
- Being ambulatory
- EDSS between 3.0-5.5
- Being literate
Key exclusion criteria (6 listed)
- Having an orthopedic problem affecting its mobility
- Having psychiatric problems, severe cognitive impairment, or epilepsy in addition to the MS diagnosis
- Blurred vision or visual impairment
- Pregnancy
- Having had an attack or received corticosteroid treatment 3 months before participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Exercise TrainingThe exercise training consisting of aerobic, strengthening and balance exercises will be applied for 12 weeks/3days for 1hour. One day of the exercise training will be performed in a clinical environment with a physiotherapist, and the other 2 days of the week, participants will be asked to apply asynchronous video-based telerehabilitation over the internet in their own homes. The asynchronous video-based telerehabilitation application will be performed through an account created specifically for the participant on the "www.telenororehab.com" website. The exercise program will be created according to the individual's condition and progression will be provided every 3 weeks. Patients who do not attend 3 consecutive sessions will be excluded from the study. | Other | Multimodal Exercise Training Group |
| Control GroupParticipants in the control group will be placed on the waiting list after all evaluation methods have been applied and will be re-evaluated at the end of 12 weeks. | Other | Control Group |
Primary outcome
Multiple Sclerosis Functional Composite Test (The change between the initial value and the value after 3 months will be evaluated).
Time frame: Baseline and end of weeks 12
The Multiple Sclerosis Functional Composite Test evaluates disease activity through three sections: cognitive status, and upper and lower extremity function. The Paced Auditory Serial Addition Test (PASAT) measures auditory processing speed, attention, flexibility, and calculation by having the patient add numbers presented at three-second intervals. The score is based on correct answers, with a maximum of 60 points. The Timed 25 Foot Walking Test (T25FWT) assesses lower extremity function by recording the time (in seconds) taken to walk 7.62 meters as quickly and safely as possible, with the average of two trials used for scoring. The 9-Hole Peg Test (9DPT) evaluates upper extremity function by having the patient place and remove nine pegs as quickly as possible, with scores based on the average of two trials for each hand.
Functional Magnetic Resonance Imaging (fMRI) (The change between the initial value and the value after 3 months will be evaluated).
Time frame: Baseline and end of weeks 12
fMRI is a non-invasive method that allows the examination of central nervous system function and the identification of abnormal activation patterns and/or functional connectivity caused by diseases (Rocca et al 2024).In our study, functional MRI evaluations are planned to be performed using parallel imaging sequences with a 3 T Siemens device with a 32-channel head coil. High-resolution (1 x 1 x 1 mm isotropic) sagittal 190 slices will be obtained with a T1-weighted imaging sequence (TR/TE: 7.7/3.7 ms;, FA: 8°; FOV: 256 x 256). Functional resting state data will be taken with a single-shot echo planar imaging (EPI) sequence consisting of 35 slices of 4 mm thickness, 300 dynamic shots (TR/TE: 2230/30 ms, FA: 77°; matrix: 80x80) and will last approximately 11 minutes. Before functional acquisition, magnetic field maps will be recorded in order to correct signal distortions caused by tissue inhomogeneities in the magnetic field during the analysis phase.
Brain-derived neurotrophic factor (BDNF) assessment (The change between the initial value and the value after 3 months will be evaluated).
Time frame: Baseline and end of weeks 12
BDNF is a neurotrophin that affects the survival, growth and function of neurons in the central and peripheral nervous system, provides stabilization of synapses, and regulates synaptic function, axon and dendrite branching. In our study, Enzyme-Linked Immunosorbent Assay (ELISA) will be used to assess the BDNF levels of participants. All participants will be asked not to consume alcohol and caffeine in the last 12 hours before blood collection, not to take any anti-inflammatory drugs other than their routine treatments and not to exercise. The blood samples to be collected will be centrifuged and stored at -80 degrees in Eppendorf or Falcon tubes (15 ml) (Shobeiri et al 2022; Briken et al. 2016). After the treatments are completed, the blood taken will be analyzed by experienced technicians in the laboratory together with the blood taken before exercise training.
7 secondary outcomes
The Expanded Disability Status Scale (EDSS) (The change between the initial value and the value after 3 months will be evaluated).
Time frame: Baseline and end of weeks 12
6 Minute Walk Test (6MWT) (The change between the initial value and the value after 3 months will be evaluated).
Time frame: Baseline and end of weeks 12
ActiGraph wGT3X-BT (The change between the initial value and the value after 3 months will be evaluated).
Time frame: Baseline and end of weeks 12
The Godin Leisure-Time Exercise Questionnaire (The change between the initial value and the value after 3 months will be evaluated).
Time frame: Baseline and end of weeks 12
Balance Assessment (The change between the initial value and the value after 3 months will be evaluated).
Time frame: Baseline and end of weeks 12
Fatigue Severity Scale (The change between the initial value and the value after 3 months will be evaluated).
Time frame: Baseline and end of weeks 12
Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) (The change between the initial value and the value after 3 months will be evaluated).
Time frame: Baseline and end of weeks 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Background: PubMed 38691168Rocca MA, Romano F, Tedone N, Filippi M. Advanced neuroimaging techniques to explore the effects of motor and cognitive rehabilitation in multiple sclerosis. J Neurol. 2024 Jul;271(7):3806-3848. doi: 10.1007/s00415-024-12395-0. Epub 2024 May 1.
- Background: PubMed 35239684Shobeiri P, Karimi A, Momtazmanesh S, Teixeira AL, Teunissen CE, van Wegen EEH, Hirsch MA, Yekaninejad MS, Rezaei N. Exercise-induced increase in blood-based brain-derived neurotrophic factor (BDNF) in people with multiple sclerosis: A systematic review and meta-analysis of exercise intervention trials. PLoS One. 2022 Mar 3;17(3):e0264557. doi: 10.1371/journal.pone.0264557. eCollection 2022.
- Background: PubMed 27725121Briken S, Rosenkranz SC, Keminer O, Patra S, Ketels G, Heesen C, Hellweg R, Pless O, Schulz KH, Gold SM. Effects of exercise on Irisin, BDNF and IL-6 serum levels in patients with progressive multiple sclerosis. J Neuroimmunol. 2016 Oct 15;299:53-58. doi: 10.1016/j.jneuroim.2016.08.007. Epub 2016 Aug 5.
- Background: PubMed 10355672Cutter GR, Baier ML, Rudick RA, Cookfair DL, Fischer JS, Petkau J, Syndulko K, Weinshenker BG, Antel JP, Confavreux C, Ellison GW, Lublin F, Miller AE, Rao SM, Reingold S, Thompson A, Willoughby E. Development of a multiple sclerosis functional composite as a clinical trial outcome measure. Brain. 1999 May;122 ( Pt 5):871-82. doi: 10.1093/brain/122.5.871.
- Background: PubMed 20488826Bosma LV, Kragt JJ, Brieva L, Khaleeli Z, Montalban X, Polman CH, Thompson AJ, Tintore M, Uitdehaag BM. Progression on the Multiple Sclerosis Functional Composite in multiple sclerosis: what is the optimal cut-off for the three components? Mult Scler. 2010 Jul;16(7):862-7. doi: 10.1177/1352458510370464. Epub 2010 May 20.
- Background: PubMed 6685237Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.
- Background: PubMed 12091180ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
- Background: PubMed 36518351Polhemus A, Haag C, Sieber C, Sylvester R, Kool J, Gonzenbach R, von Wyl V. Methodological heterogeneity biases physical activity metrics derived from the Actigraph GT3X in multiple sclerosis: A rapid review and comparative study. Front Rehabil Sci. 2022 Nov 28;3:989658. doi: 10.3389/fresc.2022.989658. eCollection 2022.
- Background: PubMed 20060544Weikert M, Motl RW, Suh Y, McAuley E, Wynn D. Accelerometry in persons with multiple sclerosis: measurement of physical activity or walking mobility? J Neurol Sci. 2010 Mar 15;290(1-2):6-11. doi: 10.1016/j.jns.2009.12.021. Epub 2010 Jan 8.
- Background: PubMed 16754576Cattaneo D, Regola A, Meotti M. Validity of six balance disorders scales in persons with multiple sclerosis. Disabil Rehabil. 2006 Jun 30;28(12):789-95. doi: 10.1080/09638280500404289.
- Background: PubMed 2803071Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.
- Background: PubMed 17942521Simeoni M, Auquier P, Fernandez O, Flachenecker P, Stecchi S, Constantinescu C, Idiman E, Boyko A, Beiske A, Vollmer T, Triantafyllou N, O'Connor P, Barak Y, Biermann L, Cristiano E, Atweh S, Patrick D, Robitail S, Ammoury N, Beresniak A, Pelletier J; MusiQol study group. Validation of the Multiple Sclerosis International Quality of Life questionnaire. Mult Scler. 2008 Mar;14(2):219-30. doi: 10.1177/1352458507080733. Epub 2007 Oct 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pelin Vural, MSc principal investigator
Istanbul University-Cerrahpasa Institute of Postgraduate Education
Yonca Zenginler Yazgan, PhD study chair
Istanbul University-Cerrahpasa Faculty of Health Science
Murat Kürtüncü, Prof. Dr. study chair
Istanbul University Istanbul Faculty of Medicine Department of Neurology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Exercise Training in people with Multiple Sclerosis, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pelin Vural, MSc (+905344245350, pelinvural7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiple Sclerosis Functional Composite Test (The change between the initial value and the value after 3 months will be evaluated). (time frame: Baseline and end of weeks 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06676618, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.