Exercise on Contactin-1 and Contactin-2 Level in Persons With Multiple Sclerosis

April 22, 2022 updated by: Furkan BİLEK, Firat University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Elazığ, Turkey, 23100
        • Fırat University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study will be carried out on individuals with MS followed in the Neurology Clinic of Fırat University Hospital.

Description

Inclusion Criteria:

  • definite diagnosis of RRMS according to the McDonalds criteria,
  • 18 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.

Exclusion Criteria:

  • orthopedic, cardiopulmonary, or systemic problems that prevent participation in exercises,
  • pregnancy,
  • started immunomodulatory treatment in the last 6 months,
  • participated in resistance training 3 months before inclusion in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker - Contactin 1
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Paced Auditory Serial Addition Test with 3-second stimulus (PASAT-3)
Time Frame: 8 weeks
Paced Auditory Serial Addition Test with 3-second stimulus (PASAT-3) was used as a measure of cognitive performance including information processing speed, working memory and sustained attention
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Firat University

Investigators

  • Study Director: Caner F Demir, MD professor, Firat University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

January 3, 2022

Study Completion (Actual)

March 4, 2022

Study Registration Dates

First Submitted

April 16, 2022

First Submitted That Met QC Criteria

April 22, 2022

First Posted (Actual)

April 28, 2022

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 22, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FıratUniversit

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Relapsing Remitting Multiple Sclerosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe