Aerobic Exercises for Multiple Sclerosis

NCT04545372 | Completed DMC

• 1 other identifier: P.T.REC/012/001072
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Primary Progressive

Keywords

Multiple Sclerosis; Aerobic exercises; cytokine IL-10; cytokine IL-17

Outcome Measures

Primary Outcomes (4)

• blood analysis

  serum anti inflammatory cytokine IL-10,

  serum anti inflammatory cytokine IL-10, will be assessed at 0 day

• blood analysis

  serum anti inflammatory cytokine IL-10,

  serum anti inflammatory cytokine IL-10, wil lbe assessed at 90 day

• blood analysis

  pro inflammatory cytokine IL-17

  pro inflammatory cytokine IL-17 will be assessed at 0 day

• blood analysis

  pro inflammatory cytokine IL-17

  pro inflammatory cytokine IL-17 will be assessed at 90 day

Study Arms (2)

the study group

EXPERIMENTAL

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

Other: aerobic exercise

the control group

NO INTERVENTION

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

Interventions

aerobic exercise OTHER

the study group

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

South Valley University, Faculty of Physical Therapy

Qina, 83523, Egypt

Location

Related Publications (5)

• 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.

  PMID: 12857678 BACKGROUND

• 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.

  PMID: 27313534 BACKGROUND

• 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.

  PMID: 22096637 BACKGROUND

• 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.

  PMID: 22521507 BACKGROUND

• 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.

  PMID: 11456302 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nehad A. Abo-Zaid, Ph.D

  South Valley University

  PRINCIPAL INVESTIGATOR

• Heba A. Kalifa, Ph.D

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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),
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physical therapy

Model Details: 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

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 11, 2020
• Study Start: February 2, 2015
• Primary Completion: August 4, 2018
• Study Completion: August 6, 2020
• Last Updated: September 11, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)