Multiple SclerosisNCT06595394
Effect of Combined Exercise Training in Patients With Multiple Sclerosis
A study testing Exercise and Home program in people with Multiple Sclerosis, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical trial is exercise in sarcopenic MS patients to demonstrate the effectiveness of education. The main questions it aims to answer are: -Can exercise training make a change in muscle thickness in sarcopenic MS patients? --Does exercise training have an effect on balance in sarcopenic MS patients?… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Exercise and Home program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 29 Aug 2026
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- People diagnosed with MS by a neurologist
- People with ambulation whose EDSS is 4.5 or below
- People between the ages of 18-50
- People who do not exercise regularly and are not included in an exercise program
Who cannot join
- Having been diagnosed with sarcopenia before MS diagnosis
- Having had an MS attack within the last 30 days
- Having any musculoskeletal problems that may affect walking and balance
- Having a diagnosed psychiatric disease that may affect cognitive status
- Having a neurological disease other than MS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Exercise Training in Patient With Sarcopenic Multiple Sclerosis
The aim of this clinical trial is exercise in sarcopenic MS patients to demonstrate the effectiveness of education. The main questions it aims to answer are: -Can exercise training make a change in muscle thickness in sarcopenic MS patients?
--Does exercise training have an effect on balance in sarcopenic MS patients?
- Does exercise training have an effect on the risk of falling in sarcopenic MS patients?
Participants will:
They will continue combined exercise applications 3 days a week for 8 weeks. Evaluations will be made before the application and at the end of the 8 weeks. The data will be analyzed afterwards.
Read the detailed description
A significant decrease in physical performance is observed in MS patients. The reasons for this can be changes in muscle contractile structures and symptoms such as sarcopenia. Sarcopenia is a disorder characterized by loss of skeletal muscle mass and decrease in muscle strength and physical performance. Loss of muscle mass seen outside of old age is defined as secondary sarcopenia. In recent years, studies on neurological disorders and their relationship with sarcopenia have increased. Early diagnosis of sarcopenia in neurological patients and implementation of applications aimed at this are important from an early stage. The aim of this study is to examine the effect of exercise training in sarcopenic MS patients. In the study, participants will be applied a combined exercise program 3 days a week for 8 weeks. Parameters such as muscle thickness, balance, and fall risk will be evaluated before and after physiotherapy application including aerobic exercise, balance exercises, and strengthening exercises.
- Conditions
- Multiple Sclerosis
- Being tested
- Exercise, Home program
- Keywords
- Sarcopenia, Exercise
- Medical subject headings
- Multiple Sclerosis, Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Participants in the experimental group will receive treatment for 8 weeks, 3 sessions per week. Each treatment session will be planned to last 60 minutes. People in the experimental group will receive a combined exercise training consisting of aerobic exercise, balance exercise and strengthening exercises for 8 weeks.
Home programOther
The control group will be followed with a home program for 8 weeks. Patients will be asked to apply the home program, which includes traditional physiotherapy practices, 3 days a week and this will be followed by physiotherapists.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Participants were given combined exercise training 3 days a week. Receives: Other: Exercise |
| Control group | Active comparator | Participants were followed with a home program 3 days a week. Receives: Other: Home program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle thickness
Ultrasound (US) is an easy-to-use imaging method that provides information about both muscle quality and quantity, with no risk of radiation. Muscle thickness will be assessed with US. Muscle thickness assessed with US has been shown to be consistent with gold standard measurements that assess muscle function and thickness.
Measured: 8 weeks
Secondary outcomes (7)
SARC -F
The SARC-F questionnaire was developed in 2018 for the rapid diagnosis of sarcopenia and the questionnaire was recommended in the EWGSOP2 guide in 2019 to determine possible sarcopenia. According to the EWGSOP2 guide, a score of 4 or more (0-10) from the SARC-F questionnaire is considered significant for sarcopenia.
Measured: 8 weeks
Hand grip strength measurement
Muscle strength assessment, which is one of the indicators of sarcopenia, is done by measuring handgrip strength. The measurement is performed with the JAMAR hand dynamometer upon the recommendation of the American Hand Therapists Association. The current cut-off value of handgrip strength is determined as 17.1 kg for men and 11.9 kg for women.
Measured: 8 weeks
Bioelectrical impedance analysis
Bioelectrical impedance analysis (BIA) device is used to determine body composition. At the end of the measurements, if the appendicular skeletal muscle mass is <15 in women and <20 in men according to the cut-off values recommended by EWGSOP2 (European Working Group on Sarcopenia in Older People), this indicates sarcopenia.
Measured: 8 weeks
Timed Up and Go (TUG)
TUG evaluates the functional mobility of patients with the risk of falling. The time it takes for the patient to complete a task is determined with the help of a stopwatch. TUG is an effective and reliable measurement method for the evaluation of functional mobility in patients with MS.
Measured: 8 weeks
Berg Balance Scale (BBS)
BBS was created to assess balance and fall risk. Each question is scored between 0-4 on the 14-item scale. The lowest value obtained from the scale is '0' and the highest value is '56'. According to the total values obtained from the scale; the 0-20 value range indicates severe balance disorder, the 21-40 value range indicates acceptable balance disorder and the 41-56 value range indicates that the patient has good balance.
Measured: 8 weeks
Fatigue Severity Scale (FSS)
The scale consists of 9 questions that allow MS patients to evaluate their last week. All questions are scored between 1-7 and the result is obtained by dividing the total value by 9. A result value greater than 6.1 is a sign of chronic fatigue.
Measured: 8 weeks
6 Minute Walk Test
It is used to evaluate physical performance in people with sarcopenia. The 6MWT can be used safely and easily in the evaluation of impaired functional capacity in outpatient MS patients.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024
- Primary completion30 Jun 2026
- Study completion29 Aug 2026
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tuba kolaylı, Uskudar University
- Investigators
- Sibel Aksu Yıldırım, Prof., Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595394
- Sponsor's protocol ID
- sarcopenicms11
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Exercise Training in Patient With Sarcopenic Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06595394
- Acronym / sponsor ID
- sarcopenicms11
- Conditions
- Multiple Sclerosis
- Keywords
- Sarcopenia, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 29 Aug 2026 (actual)
- First posted
- 19 Sep 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 aim of this clinical trial is exercise in sarcopenic MS patients to demonstrate the effectiveness of education. The main questions it aims to answer are: -Can exercise training make a change in muscle thickness in sarcopenic MS patients?
--Does exercise training have an effect on balance in sarcopenic MS patients?
- Does exercise training have an effect on the risk of falling in sarcopenic MS patients?
Participants will:
They will continue combined exercise applications 3 days a week for 8 weeks. Evaluations will be made before the application and at the end of the 8 weeks. The data will be analyzed afterwards.
Detailed description
A significant decrease in physical performance is observed in MS patients. The reasons for this can be changes in muscle contractile structures and symptoms such as sarcopenia. Sarcopenia is a disorder characterized by loss of skeletal muscle mass and decrease in muscle strength and physical performance. Loss of muscle mass seen outside of old age is defined as secondary sarcopenia. In recent years, studies on neurological disorders and their relationship with sarcopenia have increased. Early diagnosis of sarcopenia in neurological patients and implementation of applications aimed at this are important from an early stage. The aim of this study is to examine the effect of exercise training in sarcopenic MS patients. In the study, participants will be applied a combined exercise program 3 days a week for 8 weeks. Parameters such as muscle thickness, balance, and fall risk will be evaluated before and after physiotherapy application including aerobic exercise, balance exercises, and strengthening exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: ExerciseParticipants were given combined exercise training 3 days a week. |
| Control group | Active comparator | Other: Home programParticipants were followed with a home program 3 days a week. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- People diagnosed with MS by a neurologist
- People with ambulation whose EDSS is 4.5 or below
- People between the ages of 18-50
- People who do not exercise regularly and are not included in an exercise program
Key exclusion criteria (5 listed)
- Having been diagnosed with sarcopenia before MS diagnosis
- Having had an MS attack within the last 30 days
- Having any musculoskeletal problems that may affect walking and balance
- Having a diagnosed psychiatric disease that may affect cognitive status
- Having a neurological disease other than MS
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 |
|---|---|---|
| ExerciseParticipants in the experimental group will receive treatment for 8 weeks, 3 sessions per week. Each treatment session will be planned to last 60 minutes. People in the experimental group will receive a combined exercise training consisting of aerobic exercise, balance exercise and strengthening exercises for 8 weeks. | Other | Interventional group |
| Home programThe control group will be followed with a home program for 8 weeks. Patients will be asked to apply the home program, which includes traditional physiotherapy practices, 3 days a week and this will be followed by physiotherapists. | Other | Control group |
Primary outcome
Muscle thickness
Time frame: 8 weeks
Ultrasound (US) is an easy-to-use imaging method that provides information about both muscle quality and quantity, with no risk of radiation. Muscle thickness will be assessed with US. Muscle thickness assessed with US has been shown to be consistent with gold standard measurements that assess muscle function and thickness.
7 secondary outcomes
SARC -F
Time frame: 8 weeks
Hand grip strength measurement
Time frame: 8 weeks
Bioelectrical impedance analysis
Time frame: 8 weeks
Timed Up and Go (TUG)
Time frame: 8 weeks
Berg Balance Scale (BBS)
Time frame: 8 weeks
Fatigue Severity Scale (FSS)
Time frame: 8 weeks
6 Minute Walk Test
Time frame: 8 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 18 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Sibel Aksu Yıldırım, Prof. principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Home program in people with Multiple Sclerosis, run by Uskudar University 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 4 inclusion and 5 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 18 Sep 2026. 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?
Muscle thickness (time frame: 8 weeks). 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 18 Sep 2026.