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Completed

NCT Number: NCT06583967

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

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.

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Key information

Conditions

Multiple Sclerosis (MS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Motor Activity Multiple Sclerosis Nervous System Diseases

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Soroka Medical Center, Beersheba, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Physical training

Other

Group 1 - Elliptical Trainer Group 2 - Treadmill

Primary outcomes

  1. 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.

Secondary outcomes

  1. 6 Minute Walk Test (6MWT)

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

    Each subject will be asked to perform a 6 min walk and the max distance to be measured,

  2. Timed Up & Go (TUG)

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

    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

  3. Berg Balance Scale (BBS)

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

    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.

  4. 10 Meter Walk Test (10MWT)

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

    The 10 Metre Walk Test is a performance measure used to assess walking or gait speed in meters per second over a short distance

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Registry information

Official study 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)

Acronym: MS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 4, 2024
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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