Relapsing Remitting Multiple SclerosisNCT05351411
Exercise on Contactin-1 and Contactin-2 Level in Persons With Multiple Sclerosis
An observational study of Relapsing Remitting Multiple Sclerosis, run by Firat University at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 4 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be carried out on individuals with MS followed in the Neurology Clinic of Fırat University Hospital.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Multiple Sclerosis, exercise, contactin 1, contactin 2
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
Participants in the control group maintained their therapeutic routine and had the opportunity to take part in the combined progressive functional exercise intervention after follow-up assessments had been conducted.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (1)
Paced Auditory Serial Addition Test with 3-second stimulus (PASAT-3)
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Nov 2021
- Primary completion3 Jan 2022
- Study completion4 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furkan BİLEK, Firat University
- Investigators
- Caner F Demir, MD professor, Study director, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351411
- Sponsor's protocol ID
- FıratUniversit
- Status last verified
- Apr 2022
- First submitted
- 16 Apr 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29576504Negaresh 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.
PubMed 30734989Sandroff 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.
PubMed 34049322Motl 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.
PubMed 29287750Schutzer 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.
PubMed 24039694Derfuss 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.
PubMed 19416878Shimoda 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.
PubMed 19262165Colakoglu 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.
PubMed 24385581Dalgas U, Ingemann-Hansen T, Stenager E. Physical Exercise and MS Recommendations. Int MS J. 2009 Apr;16(1):5-11.
PubMed 19413920Ocklenburg 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.
PubMed 27864734
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05351411
- Acronym / sponsor ID
- FıratUniversit
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Multiple Sclerosis, exercise, contactin 1, contactin 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 3 Jan 2022 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be carried out on individuals with MS followed in the Neurology Clinic of Fırat University Hospital.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participants in the control group maintained their therapeutic routine and had the opportunity to take part in the combined progressive functional exercise intervention after follow-up assessments had been conducted. | Other | combined progressive functional exercise |
Primary outcome
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.
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.
1 secondary outcome
Paced Auditory Serial Addition Test with 3-second stimulus (PASAT-3)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Background: PubMed 29576504Thompson 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.
- Background: PubMed 30734989Negaresh 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.
- Background: PubMed 34049322Sandroff 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.
- Background: PubMed 29287750Motl 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.
- Background: PubMed 24039694Schutzer 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.
- Results publication: PubMed 19416878Derfuss 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.
- Results publication: PubMed 19262165Shimoda 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.
- Results publication: PubMed 24385581Colakoglu 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.
- Results publication: PubMed 19413920Dalgas U, Ingemann-Hansen T, Stenager E. Physical Exercise and MS Recommendations. Int MS J. 2009 Apr;16(1):5-11.
- Results publication: PubMed 27864734Ocklenburg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caner F Demir, MD professor study director
Firat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Remitting Multiple Sclerosis, run by Firat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker - Contactin 1 (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05351411, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.