NCT05351411

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 16, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

April 16, 2022

Last Update Submit

April 22, 2022

Conditions

Keywords

Multiple Sclerosisexercisecontactin 1contactin 2

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

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Study Sites (1)

Fırat university

Elâzığ, 23100, Turkey (Türkiye)

Location

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: 29576504BACKGROUND
  • Negaresh 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: 30734989BACKGROUND
  • Sandroff 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: 34049322BACKGROUND
  • Motl 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: 29287750BACKGROUND
  • Schutzer 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: 24039694BACKGROUND
  • Derfuss 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.

  • Shimoda 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.

  • Colakoglu 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.

  • Dalgas U, Ingemann-Hansen T, Stenager E. Physical Exercise and MS Recommendations. Int MS J. 2009 Apr;16(1):5-11.

  • Ocklenburg 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.

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple SclerosisMotor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • Caner F Demir, MD professor

    Firat University

    STUDY DIRECTOR

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

Locations