- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04545372
Aerobic Exercises for Multiple Sclerosis
Effect of Aerobic Exercises on Immune System in Patients With Multiple Sclerosis
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Qina,, Egypt, 83523
- South Valley University, Faculty of Physical Therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: the study group
the study group (GA) was treated only by the disease modifying drug (interferon beta-1a) in addition to aerobic exercise.
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NO_INTERVENTION: the control group
control group (GB)was treated only by the disease modifying drug (interferon beta-1a)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood analysis
Time Frame: serum anti inflammatory cytokine IL-10, will be assessed at 0 day
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serum anti inflammatory cytokine IL-10,
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serum anti inflammatory cytokine IL-10, will be assessed at 0 day
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blood analysis
Time Frame: serum anti inflammatory cytokine IL-10, wil lbe assessed at 90 day
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serum anti inflammatory cytokine IL-10,
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serum anti inflammatory cytokine IL-10, wil lbe assessed at 90 day
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blood analysis
Time Frame: pro inflammatory cytokine IL-17 will be assessed at 0 day
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pro inflammatory cytokine IL-17
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pro inflammatory cytokine IL-17 will be assessed at 0 day
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blood analysis
Time Frame: pro inflammatory cytokine IL-17 will be assessed at 90 day
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pro inflammatory cytokine IL-17
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pro inflammatory cytokine IL-17 will be assessed at 90 day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Heba A. Kalifa, Ph.D, Cairo University
Publications and helpful links
General Publications
- Steensberg A, Fischer CP, Keller C, Moller K, Pedersen BK. IL-6 enhances plasma IL-1ra, IL-10, and cortisol in humans. Am J Physiol Endocrinol Metab. 2003 Aug;285(2):E433-7. doi: 10.1152/ajpendo.00074.2003.
- Barry A, Cronin O, Ryan AM, Sweeney B, Yap SM, O'Toole O, Allen AP, Clarke G, O'Halloran KD, Downer EJ. Impact of Exercise on Innate Immunity in Multiple Sclerosis Progression and Symptomatology. Front Physiol. 2016 Jun 2;7:194. doi: 10.3389/fphys.2016.00194. eCollection 2016.
- Haegert DG. Multiple sclerosis: a disorder of altered T-cell homeostasis. Mult Scler Int. 2011;2011:461304. doi: 10.1155/2011/461304. Epub 2011 Sep 15.
- Broughton SE, Hercus TR, Lopez AF, Parker MW. Cytokine receptor activation at the cell surface. Curr Opin Struct Biol. 2012 Jun;22(3):350-9. doi: 10.1016/j.sbi.2012.03.015. Epub 2012 Apr 20.
- McDonald WI, Compston A, Edan G, Goodkin D, Hartung HP, Lublin FD, McFarland HF, Paty DW, Polman CH, Reingold SC, Sandberg-Wollheim M, Sibley W, Thompson A, van den Noort S, Weinshenker BY, Wolinsky JS. Recommended diagnostic criteria for multiple sclerosis: guidelines from the International Panel on the diagnosis of multiple sclerosis. Ann Neurol. 2001 Jul;50(1):121-7. doi: 10.1002/ana.1032.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/001072
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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