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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • Feray Güngör

    Istanbul, 34147

Other trials in Turkey (Türkiye)

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.

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 groups in NCT05957809
Study groupRoleWhat they receive
1. Structured exercise groupExperimentalThis 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 groupNo interventionThis 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.

  1. 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

  2. Postural Stability Test

    Anterior-posterior, mediolateral and overall sway will be evaluated with the Postural Stability Test in Biodex Balance System.

    Measured: 24 weeks

  3. 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

  4. Muscle strength

    Quadriceps, hamstring, ankle dorsi and plantar flexors muscle strength will be assessed with Hand Held Dynamometer.

    Measured: 24 weeks

Secondary outcomes (4)
  1. 2 Minute Walk Test

    It will be used to evaluate walking speed.

    Measured: Baseline, 8th and 24th weeks

  2. Timed 25 Foot Walk Test

    It will be used to evaluate walking distance.

    Measured: Baseline, 8th and 24th weeks

  3. Brief International Cognitive Assessment for MS (BICAMS)

    BICAMS will be used to evaluate cognitive functions.

    Measured: Baseline, 8th and 24th weeks

  4. 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.

  1. First posted24 Jul 2023
  2. Study start20 Jul 2023
  3. Primary completion20 Mar 2025
  4. Study completion20 May 2025

Resources

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)
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

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.

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