Aerobic Exercises for Multiple Sclerosis

Sponsor

South Valley University (Other)

Overall Status

Completed

CT.gov ID

NCT04545372

Collaborator

(none)

Enrollment

Location

Arms

66.1

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS) .It is the most common neurological disorders affecting young adults.Multiple sclerosis is an autoimmune disease that results in progressive neural degeneration. Cytokines play an important role in the pathogenesis and treatment of MS.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis, Primary Progressive	Other: aerobic exercise	N/A

Detailed Description

This research aims to evaluate the effect of aerobic exercises on the immune system anti-inflammatory (IL-10) and pro inflammatory (IL-17) cytokines and its consequences on the functional status in the Multiple Sclerosis patients.

Aerobic exercises are a term to describe planned, structured and repetitive physical activity undertaken over a prolonged period to maintain or improve physical fitness and functional capacity .

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

study group (GA) and control group (GB) in addition to normal matched subjects (GC).The control group (GB)was treated by the disease modifying drug (interferon beta-1a) "Rebif", (GA) treated by the same drug in addition to a physical therapy program of aerobic exercises for 40 min included bicycle ergometry trainingstudy group (GA) and control group (GB) in addition to normal matched subjects (GC).The control group (GB)was treated by the disease modifying drug (interferon beta-1a) "Rebif", (GA) treated by the same drug in addition to a physical therapy program of aerobic exercises for 40 min included bicycle ergometry training

Masking:

Double (Participant, Investigator)

Masking Description:

Double (Participant, Investigator) Single (Outcomes Assessor) Blinding process to participants and care providers was impossible due to the nature of intervention therapy. Data were analyzed by an impartial statistician (outcomes assessor), referring to each arm with an encoded name: Group A (study group) and Group B (control group),

Primary Purpose:

Treatment

Official Title:

Effect of Aerobic Exercises on Immune System in Patients With Multiple Sclerosis

Actual Study Start Date :

Feb 2, 2015

Actual Primary Completion Date :

Aug 4, 2018

Actual Study Completion Date :

Aug 6, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: the study group the study group (GA) was treated only by the disease modifying drug (interferon beta-1a) in addition to aerobic exercise.	Other: aerobic exercise
No Intervention: the control group control group (GB)was treated only by the disease modifying drug (interferon beta-1a)

Arm

Intervention/Treatment

Experimental: the study group

the study group (GA) was treated only by the disease modifying drug (interferon beta-1a) in addition to aerobic exercise.

Other: aerobic exercise

No Intervention: the control group

control group (GB)was treated only by the disease modifying drug (interferon beta-1a)

Outcome Measures

Primary Outcome Measures

blood analysis [serum anti inflammatory cytokine IL-10, will be assessed at 0 day]
serum anti inflammatory cytokine IL-10,
blood analysis [serum anti inflammatory cytokine IL-10, wil lbe assessed at 90 day]
serum anti inflammatory cytokine IL-10,
blood analysis [pro inflammatory cytokine IL-17 will be assessed at 0 day]
pro inflammatory cytokine IL-17
blood analysis [pro inflammatory cytokine IL-17 will be assessed at 90 day]
pro inflammatory cytokine IL-17

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age ranged from 25 to 45 years. All the patients were remitting relapsing MS according to (revised McDonald criteria.

Duration of MS disease was one to two years before starting of the study. Last attack occurred three months ago. All patients were able to ambulate

Exclusion Criteria:

Patients with other neurological deficits , patient with significant orthopedic abnormalities for both lower limbs, patient with contracture , patient with deformities, pregnant females