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

NCT06583967 | Completed

• 1 other identifier: 0104-23-SOR
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 6 Minute Walk Test (6MWT)

  Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)

• Timed Up & Go (TUG)

  Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)

• Berg Balance Scale (BBS)

  Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)

• 10 Meter Walk Test (10MWT)

  Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)

Study Arms (2)

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.

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.

Other: Physical Training

Interventions

Physical Training OTHER

Group 1 - Elliptical Trainer Group 2 - Treadmill

Group 1 - Elliptical Trainer; Group 2 - Treadmill

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (2)

Soroka Medical Center

Beersheba, Israel, 8410101, Israel

Location

Israel ParaSport Center

Ramat Gan, Israel, 52535, Israel

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Iuly Treger, MD, PhD

  Soroka University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of Rehabilitation Department

Model Details: 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.

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 4, 2024
• Study Start: June 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: June 30, 2025
• Last Updated: January 7, 2026

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)