Clinical trial NCT06583967: The Effect of Aerobic Exercise on an Elliptical Trainer Versus a Treadmill, in People with Multiple Sclerosis
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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)
Informed Consent Form (ICF)
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Patients signed Informed Consent Form
2. At least 6 months post MS diagnosis
3. 25-55 years old adults
4. EDSS 3.0-6.5
5. Standing stability - for at least 30 seconds
6. 6MWT - minimal distance to be measured as 210 meters
7. No physical routinely training e.g. walking, elliptical or cycling within 3 months prior screening visit.

Exclusion Criteria:

1. Active Heart Disease
2. Lungs and/or respiratory system diseases
3. Metabolic Disease
4. Any other medical condition(s) which might impact the patient's participant in the study, as per PI medical judgement
5. Major medical treatment change (as per PI medical judgement) up to 12 weeks prior ICF signature by the patient.

Primary outcomes:
measure: Quality of life outcomes
timeFrame: Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)
Secondary outcomes:
measure: 6 Minute Walk Test (6MWT)
timeFrame: Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)
measure: Timed Up &amp; Go (TUG)
timeFrame: Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)
measure: Berg Balance Scale (BBS)
timeFrame: Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)
measure: 10 Meter Walk Test (10MWT)
timeFrame: Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Ramat Gan
country: Israel
facility: Israel ParaSport Center
Study officials:
affiliation: Soroka University Medical Center
name: Iuly Treger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: