Clinical trial NCT04545372: Aerobic Exercises for Multiple Sclerosis
Official title: Effect of Aerobic Exercises on Immune System in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis, Primary Progressive
Keywords: Multiple Sclerosis
Aerobic exercises
cytokine IL-10
cytokine IL-17
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2020-09-11
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 training
Primary purpose: TREATMENT

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.

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 .

Eligibility criteria: 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

Primary outcomes:
measure: blood analysis
timeFrame: serum anti inflammatory cytokine IL-10, will be assessed at 0 day
measure: blood analysis
timeFrame: serum anti inflammatory cytokine IL-10, wil lbe assessed at 90 day
measure: blood analysis
timeFrame: pro inflammatory cytokine IL-17 will be assessed at 0 day
measure: blood analysis
timeFrame: pro inflammatory cytokine IL-17 will be assessed at 90 day
Secondary outcomes:
Other outcomes:
Locations:
city: Qina,
country: Egypt
facility: South Valley University, Faculty of Physical Therapy
Study officials:
affiliation: South Valley University
name: Nehad A. Abo-Zaid, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Heba A. Kalifa, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.