The Effect of Aerobic Exercise on an Elliptical Trainer Versus a Treadmill, in People With Multiple Sclerosis (MS)

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis (MS)
• Intervention / Treatment: Other: Physical Training

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Israel
    • Beersheba, Israel, Israel, 8410101
      • Soroka Medical Center
    • Ramat Gan, Israel, Israel, 52535
      • Israel ParaSport Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 - Elliptical Trainer; 15 MS subjects will be enrolled and assigned to group 1 and to be trained (Elliptical Trainer) twice a week for 12 weeks.	Other: Physical Training; Group 1 - Elliptical Trainer Group 2 - Treadmill
Experimental: Group 2 - Treadmill; 15 MS subjects will be enrolled and assigned to group 2 and to be trained (Treadmill) twice a week for 12 weeks.	Other: Physical Training; Group 1 - Elliptical Trainer Group 2 - Treadmill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)	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)

Collaborators and Investigators

• Sponsor: Soroka University Medical Center
• Investigators: Principal Investigator: Iuly Treger, MD, PhD, Soroka University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: September 1, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 4, 2026
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Treadmill; Aerobic; Berg Balance Scale (BBS); 6 Minute Walk Test (6MWT); Elliptical trainer; Timed Up & Go (TUG); 10 Meter Walk Test (10MWT); Informed Consent Form (ICF)
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Behavior; Multiple Sclerosis; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Physical Conditioning, Human
• Other Study ID Numbers: 0104-23-SOR (Other Identifier: Soroka Medical Center, Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There isn't any plan to make IPD available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No