Multiple SclerosisNCT05957809
Structured Exercise Training in Newly Diagnosed Multiple Sclerosis
A study testing Structured exercise training in people with Multiple Sclerosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
the effectiveness of structured exercise training will be investigated for individuals with MS who are newly diagnosed and have no clinical problems. Individuals with MS included in the study will be randomly divided into two groups a Structured Exercise Group (SEG) and a Control Group (CG). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Structured exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2023to 20 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being diagnosed with MS according to McDonald diagnostic criteria
- EDSS below 2.5
- Diagnosis period less than 1 year
- Being between the ages of 18-45
- Volunteering to participate in the study
Who cannot join
- Apart from the MS diagnosis, orthopedic, neurological, psychological, etc., which will affect the evaluation results. have diseases
- Regular exercise and doing sports
- Being involved in another rehabilitation program
- Being pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Structured Exercise Training on Disease Course in Newly Diagnosed Multiple Sclerosis
the effectiveness of structured exercise training will be investigated for individuals with MS who are newly diagnosed and have no clinical problems. Individuals with MS included in the study will be randomly divided into two groups a Structured Exercise Group (SEG) and a Control Group (CG). In order to compare baseline and follow-up data, the Healthy Group (HG) will be taken and all three groups will be evaluated initially, 8. weeks and 24. weeks with primary and secondary outcome measurements. SEG, CG, and HG will be evaluated initially for postural sway, muscle strength, mobility, dexterity, cognitive function, trunk strength-endurance, and fatigue. Afterward, SEG will receive structured exercise training consisting of clinically supervised aerobic exercise and resistance training on unstable surfaces for 8 weeks, 2 days a week, with a minimum session duration of 60 minutes. Stretching and mobility exercises will be added to warm up and cool down before and after the program. CG will be on the waiting list during this process. At the end of 8 weeks, both groups will be reassessed with their initial assessment. After the 8-week program, the SEG physical activity recommendation will be given and the KG group will continue on the waiting list, and a follow-up evaluation will be made in the 24th week. This study will allow the comparison of newly diagnosed individuals with MS who do not have any physical or cognitive effects on neurological examination and healthy controls with objective and detailed evaluations, and will also reveal the evidence on the effects of planned structured exercises specific to individuals with newly diagnosed MS. During the 24-week follow-up period, the change in the clinical status of individuals with MS who received or did not receive any exercise training can be interpreted.
Read the detailed description
According to the data of the World Multiple Sclerosis (MS) atlas, the incidence of MS in our country is 51-100/100.000 and it is estimated that there are over 70.000 individuals with MS. MS continues to be the most common cause of non-traumatic neurological disability in young adults with its increasing prevalence in our country as well as all over the world. The most common problems seen in MS are deterioration of balance and postural control, decrease in muscle strength, gait problems, and cognitive and emotional functions. These effects become more visible in the later stages of the disease, but a limited number of studies reveal that there is an insidious progression from the early period. The topographical model of MS suggests that the burden of disease below the threshold is compensated by functional reserve, presents no physical problems, and symptoms become evident once the clinical threshold is crossed. Furthermore, the evidence suggests that disease activity may be continued even during the relapse-remitting phase of the disease course, highlighting the need for the use of sensitive outcome measures that can detect early disorders. Therefore, the involvement in individuals with newly diagnosed MS is ignored because it is not reflected in activities of daily living, is compensated by functional reserve because it is below the threshold value, and cannot be detected in the non-objective clinical neurological examination. Rehabilitation approaches for individuals with newly diagnosed MS are needed in order to benefit from the protective effects of exercise and to prevent the effects from progressing. Therefore, within the scope of our proposed project, the effectiveness of structured exercise training will be investigated for individuals with MS who are newly diagnosed and have no clinical problems. Individuals with MS included in the study will be randomly divided into two groups a Structured Exercise Group (SEG) and a Control Group (CG). In order to compare baseline and follow-up data, the Healthy Group (HG) will be taken and all three groups will be evaluated initially, 8. weeks and 24. weeks with primary and secondary outcome measurements. SEG, CG, and HG will be evaluated initially for postural sway, muscle strength, mobility, dexterity, cognitive function, trunk strength-endurance, and fatigue. Afterward, SEG will receive structured exercise training consisting of clinically supervised aerobic exercise and resistance training on unstable surfaces for 8 weeks, 2 days a week, with a minimum session duration of 60 minutes. Stretching and mobility exercises will be added to warm up and cool down before and after the program. CG will be on the waiting list during this process. At the end of 8 weeks, both groups will be reassessed with their initial assessment. After the 8-week program, the SEG physical activity recommendation will be given and the KG group will continue on the waiting list, and a follow-up evaluation will be made in the 24th week. This study will allow the comparison of newly diagnosed individuals with MS who do not have any physical or cognitive effects on neurological examination and healthy controls with objective and detailed evaluations, and will also reveal the evidence on the effects of planned structured exercises specific to individuals with newly diagnosed MS. During the 24-week follow-up period, the change in the clinical status of individuals with MS who received or did not receive any exercise training can be interpreted.
- Conditions
- Multiple Sclerosis
- Being tested
- Structured exercise training
- Keywords
- Multiple sclerosis, newly diagnosis, exercise, postural sway, cognition
- 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.
Structured exercise trainingOther
This group will receive structured exercise training with 60-75 minute sessions per day, 2 days a week, for 8 weeks. • Warm-up program - 10 minutes
- Strength training on unstable surfaces - 25-30 minutes
- High repetition muscular endurance training - 25-30 minutes
- Cool-down program - 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| 1. Structured exercise group | Experimental | This group will receive structured exercise training with 60-75 minute sessions per day, 2 days a week, for 8 weeks. Receives: Other: Structured exercise training |
| 2. Control group | No intervention | This group will be assessed at the beginning, 8. and 24. weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Test of Sensory Integration of Balance Test
Postural sway in "open eyes-firm surface, closed eyes-firm surface, open eyes-foam surface, closed eyes-foam surface" conditions will be evaluated with the Clinical Test of Sensory Integration of Balance.
Measured: 24 weeks
Postural Stability Test
Anterior-posterior, mediolateral and overall sway will be evaluated with the Postural Stability Test in Biodex Balance System.
Measured: 24 weeks
Balance Error Scoring System Test
Postural sway in tandem position and feet together position will be evaluated with Balance Error Scoring System in Biodex Balance System.
Measured: 24 weeks
Muscle strength
Quadriceps, hamstring, ankle dorsi and plantar flexors muscle strength will be assessed with Hand Held Dynamometer.
Measured: 24 weeks
Secondary outcomes (4)
2 Minute Walk Test
It will be used to evaluate walking speed.
Measured: Baseline, 8th and 24th weeks
Timed 25 Foot Walk Test
It will be used to evaluate walking distance.
Measured: Baseline, 8th and 24th weeks
Brief International Cognitive Assessment for MS (BICAMS)
BICAMS will be used to evaluate cognitive functions.
Measured: Baseline, 8th and 24th weeks
Curl-up
It will be used to evaluate trunk flexor muscle strength. While the hips and knees are in 90º flexion position and the feet are fixed by the therapist, the individuals will be asked to flex their trunk and the number of repetitions done for 30 seconds will be recorded.
Measured: Baseline, 8th and 24th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start20 Jul 2023
- Primary completion20 Mar 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feray Güngör, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957809
- Sponsor's protocol ID
- 2023/68
- Status last verified
- May 2025
- First submitted
- 20 Jun 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Structured Exercise Training on Disease Course in Newly Diagnosed Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05957809
- Acronym / sponsor ID
- 2023/68
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, newly diagnosis, exercise, postural sway, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 24 Jul 2023 (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 effectiveness of structured exercise training will be investigated for individuals with MS who are newly diagnosed and have no clinical problems. Individuals with MS included in the study will be randomly divided into two groups a Structured Exercise Group (SEG) and a Control Group (CG). In order to compare baseline and follow-up data, the Healthy Group (HG) will be taken and all three groups will be evaluated initially, 8. weeks and 24. weeks with primary and secondary outcome measurements. SEG, CG, and HG will be evaluated initially for postural sway, muscle strength, mobility, dexterity, cognitive function, trunk strength-endurance, and fatigue. Afterward, SEG will receive structured exercise training consisting of clinically supervised aerobic exercise and resistance training on unstable surfaces for 8 weeks, 2 days a week, with a minimum session duration of 60 minutes. Stretching and mobility exercises will be added to warm up and cool down before and after the program. CG will be on the waiting list during this process. At the end of 8 weeks, both groups will be reassessed with their initial assessment. After the 8-week program, the SEG physical activity recommendation will be given and the KG group will continue on the waiting list, and a follow-up evaluation will be made in the 24th week. This study will allow the comparison of newly diagnosed individuals with MS who do not have any physical or cognitive effects on neurological examination and healthy controls with objective and detailed evaluations, and will also reveal the evidence on the effects of planned structured exercises specific to individuals with newly diagnosed MS. During the 24-week follow-up period, the change in the clinical status of individuals with MS who received or did not receive any exercise training can be interpreted.
Detailed description
According to the data of the World Multiple Sclerosis (MS) atlas, the incidence of MS in our country is 51-100/100.000 and it is estimated that there are over 70.000 individuals with MS. MS continues to be the most common cause of non-traumatic neurological disability in young adults with its increasing prevalence in our country as well as all over the world. The most common problems seen in MS are deterioration of balance and postural control, decrease in muscle strength, gait problems, and cognitive and emotional functions. These effects become more visible in the later stages of the disease, but a limited number of studies reveal that there is an insidious progression from the early period. The topographical model of MS suggests that the burden of disease below the threshold is compensated by functional reserve, presents no physical problems, and symptoms become evident once the clinical threshold is crossed. Furthermore, the evidence suggests that disease activity may be continued even during the relapse-remitting phase of the disease course, highlighting the need for the use of sensitive outcome measures that can detect early disorders. Therefore, the involvement in individuals with newly diagnosed MS is ignored because it is not reflected in activities of daily living, is compensated by functional reserve because it is below the threshold value, and cannot be detected in the non-objective clinical neurological examination. Rehabilitation approaches for individuals with newly diagnosed MS are needed in order to benefit from the protective effects of exercise and to prevent the effects from progressing. Therefore, within the scope of our proposed project, the effectiveness of structured exercise training will be investigated for individuals with MS who are newly diagnosed and have no clinical problems. Individuals with MS included in the study will be randomly divided into two groups a Structured Exercise Group (SEG) and a Control Group (CG). In order to compare baseline and follow-up data, the Healthy Group (HG) will be taken and all three groups will be evaluated initially, 8. weeks and 24. weeks with primary and secondary outcome measurements. SEG, CG, and HG will be evaluated initially for postural sway, muscle strength, mobility, dexterity, cognitive function, trunk strength-endurance, and fatigue. Afterward, SEG will receive structured exercise training consisting of clinically supervised aerobic exercise and resistance training on unstable surfaces for 8 weeks, 2 days a week, with a minimum session duration of 60 minutes. Stretching and mobility exercises will be added to warm up and cool down before and after the program. CG will be on the waiting list during this process. At the end of 8 weeks, both groups will be reassessed with their initial assessment. After the 8-week program, the SEG physical activity recommendation will be given and the KG group will continue on the waiting list, and a follow-up evaluation will be made in the 24th week. This study will allow the comparison of newly diagnosed individuals with MS who do not have any physical or cognitive effects on neurological examination and healthy controls with objective and detailed evaluations, and will also reveal the evidence on the effects of planned structured exercises specific to individuals with newly diagnosed MS. During the 24-week follow-up period, the change in the clinical status of individuals with MS who received or did not receive any exercise training can be interpreted.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Structured exercise group | Experimental | Other: Structured exercise trainingThis group will receive structured exercise training with 60-75 minute sessions per day, 2 days a week, for 8 weeks. |
| 2. Control group | No intervention | –This group will be assessed at the beginning, 8. and 24. weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being diagnosed with MS according to McDonald diagnostic criteria
- EDSS below 2.5
- Diagnosis period less than 1 year
- Being between the ages of 18-45
- Volunteering to participate in the study
Key exclusion criteria (4 listed)
- Apart from the MS diagnosis, orthopedic, neurological, psychological, etc., which will affect the evaluation results. have diseases
- Regular exercise and doing sports
- Being involved in another rehabilitation program
- Being pregnant
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 |
|---|---|---|
| Structured exercise trainingThis group will receive structured exercise training with 60-75 minute sessions per day, 2 days a week, for 8 weeks. • Warm-up program - 10 minutes * Strength training on unstable surfaces - 25-30 minutes * High repetition muscular endurance training - 25-30 minutes * Cool-down program - 10 minutes | Other | 1. Structured exercise group |
Primary outcome
Clinical Test of Sensory Integration of Balance Test
Time frame: 24 weeks
Postural sway in "open eyes-firm surface, closed eyes-firm surface, open eyes-foam surface, closed eyes-foam surface" conditions will be evaluated with the Clinical Test of Sensory Integration of Balance.
Postural Stability Test
Time frame: 24 weeks
Anterior-posterior, mediolateral and overall sway will be evaluated with the Postural Stability Test in Biodex Balance System.
Balance Error Scoring System Test
Time frame: 24 weeks
Postural sway in tandem position and feet together position will be evaluated with Balance Error Scoring System in Biodex Balance System.
Muscle strength
Time frame: 24 weeks
Quadriceps, hamstring, ankle dorsi and plantar flexors muscle strength will be assessed with Hand Held Dynamometer.
4 secondary outcomes
2 Minute Walk Test
Time frame: Baseline, 8th and 24th weeks
Timed 25 Foot Walk Test
Time frame: Baseline, 8th and 24th weeks
Brief International Cognitive Assessment for MS (BICAMS)
Time frame: Baseline, 8th and 24th weeks
Curl-up
Time frame: Baseline, 8th and 24th weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured exercise training in people with Multiple Sclerosis, run by Istanbul University - Cerrahpasa at 1 site 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Test of Sensory Integration of Balance Test (time frame: 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2025.