Back to resultsAerobic Exercises for Multiple Sclerosis
Primary Purpose
Multiple Sclerosis, Primary Progressive
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
aerobic exercise
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Primary Progressive focused on measuring Multiple Sclerosis, Aerobic exercises, cytokine IL-10, cytokine IL-17
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
Sites / Locations
- South Valley University, Faculty of Physical Therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
the study group
the control group
Arm Description
the study group (GA) was treated only by the disease modifying drug (interferon beta-1a) in addition to aerobic exercise.
control group (GB)was treated only by the disease modifying drug (interferon beta-1a)
Outcomes
Primary Outcome Measures
blood analysis
serum anti inflammatory cytokine IL-10,
blood analysis
serum anti inflammatory cytokine IL-10,
blood analysis
pro inflammatory cytokine IL-17
blood analysis
pro inflammatory cytokine IL-17
Secondary Outcome Measures
Full Information
NCT ID
NCT04545372
First Posted
August 26, 2020
Last Updated
September 3, 2020
Sponsor
South Valley University
1. Study Identification
Unique Protocol Identification Number
NCT04545372
Brief Title
Aerobic Exercises for Multiple Sclerosis
Official Title
Effect of Aerobic Exercises on Immune System in Patients With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 2, 2015 (Actual)
Primary Completion Date
August 4, 2018 (Actual)
Study Completion Date
August 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Primary Progressive
Keywords
Multiple Sclerosis, Aerobic exercises, cytokine IL-10, cytokine IL-17
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantInvestigator
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),
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
the study group
Arm Type
Experimental
Arm Description
the study group (GA) was treated only by the disease modifying drug (interferon beta-1a) in addition to aerobic exercise.
Arm Title
the control group
Arm Type
No Intervention
Arm Description
control group (GB)was treated only by the disease modifying drug (interferon beta-1a)
Intervention Type
Other
Intervention Name(s)
aerobic exercise
Primary Outcome Measure Information:
Title
blood analysis
Description
serum anti inflammatory cytokine IL-10,
Time Frame
serum anti inflammatory cytokine IL-10, will be assessed at 0 day
Title
blood analysis
Description
serum anti inflammatory cytokine IL-10,
Time Frame
serum anti inflammatory cytokine IL-10, wil lbe assessed at 90 day
Title
blood analysis
Description
pro inflammatory cytokine IL-17
Time Frame
pro inflammatory cytokine IL-17 will be assessed at 0 day
Title
blood analysis
Description
pro inflammatory cytokine IL-17
Time Frame
pro inflammatory cytokine IL-17 will be assessed at 90 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nehad A. Abo-Zaid, Ph.D
Organizational Affiliation
South Valley University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heba A. Kalifa, Ph.D
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Valley University, Faculty of Physical Therapy
City
Qina,
ZIP/Postal Code
83523
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12857678
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.
Results Reference
background
PubMed Identifier
27313534
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.
Results Reference
background
PubMed Identifier
22096637
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.
Results Reference
background
PubMed Identifier
22521507
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.
Results Reference
background
PubMed Identifier
11456302
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.
Results Reference
background
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Aerobic Exercises for Multiple Sclerosis
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