Exercise on Contactin-1 and Contactin-2 Level in Persons With Multiple Sclerosis
The Effect of Combined Progressive Functional Exercise on Contactin-1 and Contactin-2 Level in Mildly Disabled Persons With Multiple Sclerosis: A Randomized Controlled Trial
1 other identifier
observational
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 4, 2022
CompletedFirst Submitted
Initial submission to the registry
April 16, 2022
CompletedFirst Posted
Study publicly available on registry
April 28, 2022
CompletedApril 28, 2022
April 1, 2022
2 months
April 16, 2022
April 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Biomarker - Contactin 1
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.
8 weeks
Biomarker - Contactin 2
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.
8 weeks
Secondary Outcomes (1)
Paced Auditory Serial Addition Test with 3-second stimulus (PASAT-3)
8 weeks
Study Arms (2)
combined progressive functional exercise
The initial implementation for the 8-week (3 days per week) combined exercise program consisted of a progressive aerobic exercise program with a lower extremity bike. The second part of the combined exercise program, the progressive resistance training program, is designed to be consistent with the resistance training section of the Canadian Physical Activity Guidelines for adults with MS. Each prescribed session consisted of 1-3 sets and 10-15 repetitions of 10 exercises targeting major muscle groups of the upper and lower extremities. The specific exercises prescribed included lunges, chair raises/squats, calf raises, knee flexion, knee extensions, shoulder rows, shoulder lateral raises, elbow flexions, elbow extensions, and abdominal curls.
Placebo
Participants in the control group maintained their routine and had the opportunity to take part in the combined progressive functional exercise intervention after follow-up assessments had been conducted.
Eligibility Criteria
The study will be carried out on individuals with MS followed in the Neurology Clinic of Fırat University Hospital.
You may qualify if:
- definite diagnosis of RRMS according to the McDonalds criteria,
- years or older,
- EDSS levels of 1.0 - 5.5, EDSS "pyramidal functions" sub score ≥2,
- who have not had an attack in the last 3 months,
- who were patients who did not receive steroid treatment for the last 3 months.
You may not qualify if:
- orthopedic, cardiopulmonary, or systemic problems that prevent participation in exercises,
- pregnancy,
- started immunomodulatory treatment in the last 6 months,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Firat Universitylead
Study Sites (1)
Fırat university
Elâzığ, 23100, Turkey (Türkiye)
Related Publications (10)
Thompson AJ, Baranzini SE, Geurts J, Hemmer B, Ciccarelli O. Multiple sclerosis. Lancet. 2018 Apr 21;391(10130):1622-1636. doi: 10.1016/S0140-6736(18)30481-1. Epub 2018 Mar 23.
PMID: 29576504BACKGROUNDNegaresh R, Motl RW, Zimmer P, Mokhtarzade M, Baker JS. Effects of exercise training on multiple sclerosis biomarkers of central nervous system and disease status: a systematic review of intervention studies. Eur J Neurol. 2019 May;26(5):711-721. doi: 10.1111/ene.13929. Epub 2019 Mar 14.
PMID: 30734989BACKGROUNDSandroff BM, Richardson EV, Motl RW. The Neurologist as an Agent of Exercise Rehabilitation in Multiple Sclerosis. Exerc Sport Sci Rev. 2021 Oct 1;49(4):260-266. doi: 10.1249/JES.0000000000000262.
PMID: 34049322BACKGROUNDMotl RW, Sandroff BM. Exercise as a Countermeasure to Declining Central Nervous System Function in Multiple Sclerosis. Clin Ther. 2018 Jan;40(1):16-25. doi: 10.1016/j.clinthera.2017.12.001. Epub 2017 Dec 26.
PMID: 29287750BACKGROUNDSchutzer SE, Angel TE, Liu T, Schepmoes AA, Xie F, Bergquist J, Vecsei L, Zadori D, Camp DG 2nd, Holland BK, Smith RD, Coyle PK. Gray matter is targeted in first-attack multiple sclerosis. PLoS One. 2013 Sep 10;8(9):e66117. doi: 10.1371/journal.pone.0066117. eCollection 2013.
PMID: 24039694BACKGROUNDDerfuss T, Parikh K, Velhin S, Braun M, Mathey E, Krumbholz M, Kumpfel T, Moldenhauer A, Rader C, Sonderegger P, Pollmann W, Tiefenthaller C, Bauer J, Lassmann H, Wekerle H, Karagogeos D, Hohlfeld R, Linington C, Meinl E. Contactin-2/TAG-1-directed autoimmunity is identified in multiple sclerosis patients and mediates gray matter pathology in animals. Proc Natl Acad Sci U S A. 2009 May 19;106(20):8302-7. doi: 10.1073/pnas.0901496106. Epub 2009 Apr 28.
PMID: 19416878RESULTShimoda Y, Watanabe K. Contactins: emerging key roles in the development and function of the nervous system. Cell Adh Migr. 2009 Jan-Mar;3(1):64-70. doi: 10.4161/cam.3.1.7764. Epub 2009 Jan 6.
PMID: 19262165RESULTColakoglu G, Bergstrom-Tyrberg U, Berglund EO, Ranscht B. Contactin-1 regulates myelination and nodal/paranodal domain organization in the central nervous system. Proc Natl Acad Sci U S A. 2014 Jan 21;111(3):E394-403. doi: 10.1073/pnas.1313769110. Epub 2014 Jan 2.
PMID: 24385581RESULTDalgas U, Ingemann-Hansen T, Stenager E. Physical Exercise and MS Recommendations. Int MS J. 2009 Apr;16(1):5-11.
PMID: 19413920RESULTOcklenburg S, Gerding WM, Arning L, Genc E, Epplen JT, Gunturkun O, Beste C. Myelin Genes and the Corpus Callosum: Proteolipid Protein 1 (PLP1) and Contactin 1 (CNTN1) Gene Variation Modulates Interhemispheric Integration. Mol Neurobiol. 2017 Dec;54(10):7908-7916. doi: 10.1007/s12035-016-0285-5. Epub 2016 Nov 18.
PMID: 27864734RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Caner F Demir, MD professor
Firat University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
April 16, 2022
First Posted
April 28, 2022
Study Start
November 1, 2021
Primary Completion
January 3, 2022
Study Completion
March 4, 2022
Last Updated
April 28, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share