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| ID | Type | Description | Link |
|---|---|---|---|
| 0104-23-SOR | Other Identifier | Soroka Medical Center, Ethics Committee |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Training | Other | Group 1 - Elliptical Trainer Group 2 - Treadmill |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2) |
| Measure | Description | Time Frame |
|---|---|---|
| 6 Minute Walk Test (6MWT) | Each subject will be asked to perform a 6 min walk and the max distance to be measured, | Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2) |
| Timed Up & Go (TUG) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iuly Treger, MD, PhD | Soroka University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka Medical Center | Beersheba | Israel | 8410101 | Israel | ||
| Israel ParaSport Center |
There isn't any plan to make IPD available to other researchers.
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| ID | Term |
|---|---|
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
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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.
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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
| 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. | 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 | Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2) |
| Ramat Gan |
| Israel |
| 52535 |
| Israel |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
| D055687 |
| Musculoskeletal and Neural Physiological Phenomena |