NCT03826095

Brief Summary

Respiratory functions and body control are affected in patients with multiple sclerosis (MS). Because of this effect, the dependency of individuals increases in daily living activities and their quality of life decreases. We think that respiratory functions, respiratory muscle strength and trunk control affect vital mobility as well as vital importance for individuals with MS. As a result of the investigations, it is concluded that the literature is insufficient in this area. The aim of this study is to investigate the effects of pulmonary function, respiratory muscle strength and trunk control on functional mobility in individuals with MS and compare with healthy individuals.

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 Feb 2019

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

First Submitted

Initial submission to the registry

January 23, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

February 4, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2019

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

6 months

First QC Date

January 23, 2019

Last Update Submit

August 5, 2019

Conditions

Keywords

Multiple SclerosisRespiratory functionRespiratory muscle strengthTrunk controlFunctional mobility

Outcome Measures

Primary Outcomes (2)

  • 2 Minutes Walking Test

    Two Minute Walk Test (2MWT) will be performed to evaluate functional mobility.

    baseline

  • Timed Up and Go Test

    Timed Up and Go Test will be performed to evaluate functional mobility.

    baseline

Secondary Outcomes (10)

  • Respiratory Functions Test

    baseline

  • Respiratory Muscle Strength

    baseline

  • Trunk Impairment Scale

    baseline

  • Side Bridge Test (core muscles endurance)

    baseline

  • Modified Biering-Sorensen test (core muscles endurance)

    baseline

  • +5 more secondary outcomes

Study Arms (2)

Multiple Sclerosis

Patients with a clinically definitive diagnosis of MS, 0-5.5 Extended Disability Status Scale range.

Healthy individuals

Voluntary healthy individuals with similar age and gender

Eligibility Criteria

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

MS patients who are ambulatory Healthy volunteer individuals of similar age and sex to patients

You may qualify if:

  • years old
  • Having a definite MS diagnosis
  • Up to 5.5 points on the Scored Disability Status Scale (EDSS)
  • In the last 3 months have not experienced an attack
  • Mini mental test score of 24 and above
  • Acceptance to participate in the study.

You may not qualify if:

  • Having orthopedic problems
  • The presence of other neurological problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (18)

  • Tzelepis GE, McCool FD. Respiratory dysfunction in multiple sclerosis. Respir Med. 2015 Jun;109(6):671-9. doi: 10.1016/j.rmed.2015.01.018. Epub 2015 Feb 12.

    PMID: 25724874BACKGROUND
  • Smeltzer SC, Skurnick JH, Troiano R, Cook SD, Duran W, Lavietes MH. Respiratory function in multiple sclerosis. Utility of clinical assessment of respiratory muscle function. Chest. 1992 Feb;101(2):479-84. doi: 10.1378/chest.101.2.479.

    PMID: 1735276BACKGROUND
  • Smeltzer SC, Utell MJ, Rudick RA, Herndon RM. Pulmonary function and dysfunction in multiple sclerosis. Arch Neurol. 1988 Nov;45(11):1245-9. doi: 10.1001/archneur.1988.00520350083020.

    PMID: 3190505BACKGROUND
  • Mutluay FK, Gurses HN, Saip S. Effects of multiple sclerosis on respiratory functions. Clin Rehabil. 2005 Jun;19(4):426-32. doi: 10.1191/0269215505cr782oa.

    PMID: 15929512BACKGROUND
  • Smeltzer SC, Lavietes MH. Reliability of maximal respiratory pressures in multiple sclerosis. Chest. 1999 Jun;115(6):1546-52. doi: 10.1378/chest.115.6.1546.

    PMID: 10378547BACKGROUND
  • Sadovnick AD, Eisen K, Ebers GC, Paty DW. Cause of death in patients attending multiple sclerosis clinics. Neurology. 1991 Aug;41(8):1193-6. doi: 10.1212/wnl.41.8.1193.

    PMID: 1866003BACKGROUND
  • Mutluay FK, Demir R, Ozyilmaz S, Caglar AT, Altintas A, Gurses HN. Breathing-enhanced upper extremity exercises for patients with multiple sclerosis. Clin Rehabil. 2007 Jul;21(7):595-602. doi: 10.1177/0269215507075492.

    PMID: 17702701BACKGROUND
  • Lanzetta D, Cattaneo D, Pellegatta D, Cardini R. Trunk control in unstable sitting posture during functional activities in healthy subjects and patients with multiple sclerosis. Arch Phys Med Rehabil. 2004 Feb;85(2):279-83. doi: 10.1016/j.apmr.2003.05.004.

    PMID: 14966714BACKGROUND
  • Fry DK, Huang M, Rodda BJ. Core muscle strength and endurance measures in ambulatory persons with multiple sclerosis: validity and reliability. Int J Rehabil Res. 2015 Sep;38(3):206-12. doi: 10.1097/MRR.0000000000000109.

    PMID: 25647356BACKGROUND
  • Sebastiao E, Sandroff BM, Learmonth YC, Motl RW. Validity of the Timed Up and Go Test as a Measure of Functional Mobility in Persons With Multiple Sclerosis. Arch Phys Med Rehabil. 2016 Jul;97(7):1072-7. doi: 10.1016/j.apmr.2015.12.031. Epub 2016 Mar 2.

    PMID: 26944709BACKGROUND
  • American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.

    PMID: 12186831BACKGROUND
  • Black LF, Hyatt RE. Maximal respiratory pressures: normal values and relationship to age and sex. Am Rev Respir Dis. 1969 May;99(5):696-702. doi: 10.1164/arrd.1969.99.5.696. No abstract available.

    PMID: 5772056BACKGROUND
  • Standardization of Spirometry, 1994 Update. American Thoracic Society. Am J Respir Crit Care Med. 1995 Sep;152(3):1107-36. doi: 10.1164/ajrccm.152.3.7663792. No abstract available.

    PMID: 7663792BACKGROUND
  • Verheyden G, Nuyens G, Nieuwboer A, Van Asch P, Ketelaer P, De Weerdt W. Reliability and validity of trunk assessment for people with multiple sclerosis. Phys Ther. 2006 Jan;86(1):66-76. doi: 10.1093/ptj/86.1.66.

    PMID: 16386063BACKGROUND
  • Gijbels D, Eijnde BO, Feys P. Comparison of the 2- and 6-minute walk test in multiple sclerosis. Mult Scler. 2011 Oct;17(10):1269-72. doi: 10.1177/1352458511408475. Epub 2011 Jun 3.

    PMID: 21642370BACKGROUND
  • Bliss LS, Teeple P. Core stability: the centerpiece of any training program. Curr Sports Med Rep. 2005 Jun;4(3):179-83. doi: 10.1007/s11932-005-0064-y.

    PMID: 15907272BACKGROUND
  • Moreau CE, Green BN, Johnson CD, Moreau SR. Isometric back extension endurance tests: a review of the literature. J Manipulative Physiol Ther. 2001 Feb;24(2):110-22. doi: 10.1067/mmt.2001.112563.

    PMID: 11208223BACKGROUND
  • Ozen MS, Calik-Kutukcu E, Salci Y, Karanfil E, Tuncer A, Armutlu K. Is there a relationship between respiratory function and trunk control and functional mobility in patients with relapsing-remitting multiple sclerosis? Neurol Res. 2023 Jul;45(7):619-626. doi: 10.1080/01616412.2023.2176628. Epub 2023 Feb 13.

Related Links

MeSH Terms

Conditions

Multiple SclerosisRespiratory Aspiration

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • MELIKE S CENGİZ

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 23, 2019

First Posted

February 1, 2019

Study Start

February 4, 2019

Primary Completion

July 26, 2019

Study Completion

August 2, 2019

Last Updated

August 6, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations