Clinical Trials Logo

Clinical Trial Summary

Little is known about the potential effects of exercise on the underlying disease mechanisms in multiple sclerosis (MS). Although contactin-1 and contactin-2 are known as two proteins involved in axonal regeneration, it is unclear whether these proteins are induced by exercise in persons with MS (PwMS). The aim of this study was to determine the serum levels of contactin-1 and contactin-2 in PwMS and to investigate the change of these markers with exercise. Although contactin-1 and contactin-2 are known as two proteins involved in axonal regeneration, the mechanism of action of these proteins in MS patients has not been fully elucidated in the literature. The investigators' aim was to determine the serum levels of contactin-1 and contactin-2 in a group of relapsing-remitting multiple sclerosis (RRMS) patients and to evaluate the change of these markers with exercise. Thus, the investigators think that a valuable contribution will be made to the literature to shed light on the role of biomarkers in the mechanism mediating the beneficial effects of exercise in MS. In addition, as far as the investigators know, this study is the first to investigate the effect of exercise on contactin-1 and contactin-2 serum levels in MS patients.


Clinical Trial Description

This randomized controlled trial with a blinded outcome assessment evaluated an 8-week (3 sessions per week) training intervention to determine the effect of exercise on contactin-1 and contactin-2 in persons with RRMS. The participants were divided into the intervention and control groups by stratified randomization. Stratification was randomly assigned as 1≤ EDSS ≤ 3 and 3< EDSS ≤5.5 using Windows-based SPSS 25.0. (SPSS Inc., Chicago, Illinois, USA). All measurements and tests were performed before and after the 8-week exercise program. Blood samples were taken for analysis of contactin-1 and contactin-2 serum levels, after which participants completed a cognitive performance and a cardiopulmonary exercise test. The current study was approved by the Fırat University Human Research Ethics Local Committee (2021/12-38) and was conducted in accordance with the Declaration of Helsinki. All participants were informed about the study and their written informed consent was obtained before the study. Participants performed a graded cardiopulmonary exercise test on a cycle ergometer (Ergoline Ergoselect 200; Ergoline GMBH, Bitz, Germany) at the beginning to determine their maximum aerobic capacity. The test was stopped at the moment of voluntary exhaustion, when patients were unable to maintain cadence (<50 rpm), the maximum effort was achieved, or for safety reasons. Venous blood was drawn using venipuncture and clotted for serum and centrifuged at 4000g for 5 minutes at 4°C. Serum samples then were aliquoted, and stored at -80°C until were assayed with enzyme-linked immunosorbent assay (ELISA) analysis. The serum levels of Contactin-1 (Cat.No: E-EL-H1498) and Contactin-2 (Cat.No: E-EL-H1499) were measured with commercially available specific human ELISA kits (Elabscience, Houston, Texas, United States). Paced Auditory Serial Addition Test with the 3-second stimulus (PASAT-3) was used as a measure of cognitive performance including information processing speed, working memory and sustained attention ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05351411
Study type Observational
Source Firat University
Contact
Status Completed
Phase
Start date November 1, 2021
Completion date March 4, 2022

See also
  Status Clinical Trial Phase
Completed NCT01945359 - Pilot Study to Assess Disease Stability in a Natalizumab to Dimethyl Fumarate Crossover Design N/A
Completed NCT01456416 - Glatiramer Acetate for Multiple Sclerosis With Autoimmune Comorbidities Phase 4
Completed NCT01450124 - Safety, Tolerability And Mechanism Of Action Of Boswellic Acids (BA) In Multiple Sclerosis (SABA) Phase 2
Recruiting NCT05277740 - Implementation of a Novel Functional Eye-Tracking Biomarker for Multiple Sclerosis
Completed NCT03718247 - Utilization of the Ketogenic Diet in Patient With Relapsing Remitting MS
Active, not recruiting NCT03471338 - Neuropsychological Management of Multiple Sclerosis: Benefits of a Computerised Semi-autonomous At-home Cognitive Rehabilitation Programme N/A
Recruiting NCT03004079 - Clinical Importance of Glucose Regulation in Relapsing MS
Terminated NCT02266121 - Improving Cognitive Aptitudes With tDCS in Patients With Multiple Sclerosis N/A
Completed NCT01963611 - Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1) Phase 2
Active, not recruiting NCT01464905 - Phase 3 Study to Evaluate Efficacy and Safety of NU100 in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Phase 3
Completed NCT01225289 - Impact of Vitamin A Supplementation on Immune System in Multiple Sclerosis Patients Phase 4
Recruiting NCT00242268 - A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple Sclerosis Phase 3
Completed NCT00203086 - A Study to Evaluate the Long Term Safety and Effectiveness of Novantrone Therapy Followed by Copaxone Treatment for Multiple Sclerosis Phase 4
Completed NCT00616187 - Atorvastatin in Relapsing-Remitting Multiple Sclerosis Phase 2
Recruiting NCT06083753 - Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple Sclerosis Phase 2
Active, not recruiting NCT04602390 - Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis Phase 1
Recruiting NCT06159712 - Comparative Study of High-Efficacy Disease Modifying Treatment of Relapsing Multiple Sclerosis N/A
Recruiting NCT04604041 - Investigation of Subclinical Markers of Multiple Sclerosis
Terminated NCT03536559 - Nanocrystalline Gold to Treat Remyelination Failure in Chronic Optic Neuropathy In Multiple Sclerosis Phase 2
Completed NCT02490982 - Teriflunomide Observational Effectiveness Study