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

Soroka University Medical Center

Status: Completed

Conditions: Multiple Sclerosis (MS)

Treatments: Other: Physical Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06583967

0104-23-SOR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Group 1 - Elliptical Trainer

Experimental group

Description:

15 MS subjects will be enrolled and assigned to group 1 and to be trained (Elliptical Trainer) twice a week for 12 weeks.

Treatment:

Other: Physical Training

Group 2 - Treadmill

Experimental group

Description:

15 MS subjects will be enrolled and assigned to group 2 and to be trained (Treadmill) twice a week for 12 weeks.

Treatment:

Other: Physical Training