Multiple Sclerosis (MS)MSNCT06583967
The Effect of Aerobic Exercise on an Elliptical Trainer Versus a Treadmill, in People With Multiple Sclerosis
A study testing Physical Training in people with Multiple Sclerosis (MS), run by Soroka University Medical Center at 2 sites in Israel.
Trial summary
The aim of this study is to examine the effects of aerobic exercise training using an elliptical trainer compared to a treadmill on gait and walking abilities, expressed in dynamic stability, balance, and walking speed, in people with Multiple Sclerosis with moderate severity. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Multiple Sclerosis (MS)
- What is being tested?
- Physical Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesIsrael
- Study dates
- 1 Jun 2024to 30 Jun 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients signed Informed Consent Form
- At least 6 months post MS diagnosis
- 25-55 years old adults
- EDSS 3.0-6.5
- Standing stability - for at least 30 seconds
- 6MWT - minimal distance to be measured as 210 meters
- No physical routinely training e.g. walking, elliptical or cycling within 3 months prior screening visit.
Who cannot join
- Active Heart Disease
- Lungs and/or respiratory system diseases
- Metabolic Disease
- Any other medical condition(s) which might impact the patient's participant in the study, as per PI medical judgement
- Major medical treatment change (as per PI medical judgement) up to 12 weeks prior ICF signature by the patient.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Soroka Medical Center
Beersheba, Israel, 8410101
Israel ParaSport Center
Ramat Gan, Israel, 52535
About this study
Official title: The Effect of Aerobic Exercise on an Elliptical Trainer Versus a Treadmill, on Gait and Walking Abilities, Expressed in Dynamic Stability, Balance and Walking Speed, in People With Multiple Sclerosis (MS)
The aim of this study is to examine the effects of aerobic exercise training using an elliptical trainer compared to a treadmill on gait and walking abilities, expressed in dynamic stability, balance, and walking speed, in people with Multiple Sclerosis with moderate severity.
Read the detailed description
A total of 30 MS subjects to be enrolled in the study. Subjects to be assigned into one of two groups named: Group 1 - Elliptical Training and Group 2 - Treadmill Training. Effort capacity will measured by heart rate and RPE.
Outcome measures will be measured by using, 6 min. walking test (6MWT), Timed Up \& Go (TUG), Berg Balance Scale (BBS) and 10 Meter Walk Test (10MWT) to be used to assess the quality of life at Baseline (T0), During study - 6 weeks from baseline (T1), End of training program - 12 weeks from baseline (T2) and 6 weeks post T2 (T3).
The exercise program to be applied for 12 weeks with 2 trainings per week.
- Conditions
- Multiple Sclerosis (MS)
- Being tested
- Physical Training
- Keywords
- Aerobic, Exercise, Elliptical trainer, Treadmill, 6 Minute Walk Test (6MWT), Timed Up & Go (TUG), Berg Balance Scale (BBS), 10 Meter Walk Test (10MWT), Informed Consent Form (ICF)
- 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.
Physical TrainingOther
Group 1 - Elliptical Trainer Group 2 - Treadmill
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Elliptical Trainer | Experimental | 15 MS subjects will be enrolled and assigned to group 1 and to be trained (Elliptical Trainer) twice a week for 12 weeks. Receives: Other: Physical Training |
| Group 2 - Treadmill | Experimental | 15 MS subjects will be enrolled and assigned to group 2 and to be trained (Treadmill) twice a week for 12 weeks. Receives: Other: Physical Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life outcomes
Quality of life to be assessed by using a Short-form 36 health status questionnaire (SF-36). SF-36 consists of 36 questions in total. Each participant will be asked to fill in the questionnaire alone and by reading it themselves.
Measured: Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)
Secondary outcomes (4)
6 Minute Walk Test (6MWT)
Each subject will be asked to perform a 6 min walk and the max distance to be measured,
Measured: Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)
Timed Up & Go (TUG)
Patients wear their regular footwear and can use a walking aid, if needed. The patient stands up upon therapist\'s command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated
Measured: Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)
Berg Balance Scale (BBS)
The Berg Balance Scale (BBS) is used to objectively determine a patient\'s ability (or inability) to safely balance during a series of predetermined tasks.
Measured: Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)
10 Meter Walk Test (10MWT)
The 10 Metre Walk Test is a performance measure used to assess walking or gait speed in meters per second over a short distance
Measured: Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start1 Jun 2024
- Primary completion28 Feb 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will assess the effect of 12 weeks of aerobic exercise on an elliptical trainer (group 1) vs a treadmill (group 2), on gait and walking abilities, expressed in dynamic stability, balance and walking speed, in people with Multiple Sclerosis.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iuly Treger, M.D., PhD, MHA, Soroka University Medical Center
- Investigators
- Iuly Treger, MD, PhD, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583967
- Sponsor's protocol ID
- 0104-23-SOR
- Other IDs
- 0104-23-SOR
- Acronym
- MS
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There isn't any plan to make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aerobic Exercise on an Elliptical Trainer Versus a Treadmill, on Gait and Walking Abilities, Expressed in Dynamic Stability, Balance and Walking Speed, in People With Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT06583967
- Acronym / sponsor ID
- MS / 0104-23-SOR
- Conditions
- Multiple Sclerosis (MS)
- Keywords
- Aerobic, Exercise, Elliptical trainer, Treadmill, 6 Minute Walk Test (6MWT), Timed Up & Go (TUG), Berg Balance Scale (BBS), 10 Meter Walk Test (10MWT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 4 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 study is to examine the effects of aerobic exercise training using an elliptical trainer compared to a treadmill on gait and walking abilities, expressed in dynamic stability, balance, and walking speed, in people with Multiple Sclerosis with moderate severity.
Detailed description
A total of 30 MS subjects to be enrolled in the study. Subjects to be assigned into one of two groups named: Group 1 - Elliptical Training and Group 2 - Treadmill Training. Effort capacity will measured by heart rate and RPE.
Outcome measures will be measured by using, 6 min. walking test (6MWT), Timed Up \& Go (TUG), Berg Balance Scale (BBS) and 10 Meter Walk Test (10MWT) to be used to assess the quality of life at Baseline (T0), During study - 6 weeks from baseline (T1), End of training program - 12 weeks from baseline (T2) and 6 weeks post T2 (T3).
The exercise program to be applied for 12 weeks with 2 trainings per week.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will assess the effect of 12 weeks of aerobic exercise on an elliptical trainer (group 1) vs a treadmill (group 2), on gait and walking abilities, expressed in dynamic stability, balance and walking speed, in people with Multiple Sclerosis.
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Elliptical Trainer | Experimental | Other: Physical Training15 MS subjects will be enrolled and assigned to group 1 and to be trained (Elliptical Trainer) twice a week for 12 weeks. |
| Group 2 - Treadmill | Experimental | Other: Physical Training15 MS subjects will be enrolled and assigned to group 2 and to be trained (Treadmill) twice a week for 12 weeks. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients signed Informed Consent Form
- At least 6 months post MS diagnosis
- 25-55 years old adults
- EDSS 3.0-6.5
- Standing stability - for at least 30 seconds
Key exclusion criteria (5 listed)
- Active Heart Disease
- Lungs and/or respiratory system diseases
- Metabolic Disease
- Any other medical condition(s) which might impact the patient's participant in the study, as per PI medical judgement
- Major medical treatment change (as per PI medical judgement) up to 12 weeks prior ICF signature by the patient.
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 |
|---|---|---|
| Physical TrainingGroup 1 - Elliptical Trainer Group 2 - Treadmill | Other | Group 1 - Elliptical Trainer, Group 2 - Treadmill |
Primary outcome
Quality of life outcomes
Time frame: Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)
Quality of life to be assessed by using a Short-form 36 health status questionnaire (SF-36). SF-36 consists of 36 questions in total. Each participant will be asked to fill in the questionnaire alone and by reading it themselves.
4 secondary outcomes
6 Minute Walk Test (6MWT)
Time frame: Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)
Timed Up & Go (TUG)
Time frame: Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)
Berg Balance Scale (BBS)
Time frame: Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)
10 Meter Walk Test (10MWT)
Time frame: Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)
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 7 Jan 2026.
- Individual participant dataSharing planned: No. There isn't any plan to make IPD available to other researchers.
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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.
Iuly Treger, MD, PhD principal investigator
Soroka University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Training in people with Multiple Sclerosis (MS), run by Soroka University Medical Center at 2 sites in Israel.
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 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 7 Jan 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 Israel. 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?
Quality of life outcomes (time frame: Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)). 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 7 Jan 2026.