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Physical TherapyNCT03826095

Respiratory Functions, Trunk Control and Mobility Evaluation in Multiple Sclerosis

An observational study of Physical Therapy, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Physical Therapy
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
4 Feb 2019to 2 Aug 2019
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
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 18-65 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.

Who cannot join

  • Having orthopedic problems
  • The presence of other neurological problems

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Hacettepe University

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effects of Respiratory Functions and Trunk Control on Functional Mobility in Individuals With Multiple Sclerosis

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.

Keywords
Multiple Sclerosis, Respiratory function, Respiratory muscle strength, Trunk control, Functional mobility
Medical subject headings
Multiple Sclerosis, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03826095
Study groupRoleWhat they receive
Multiple SclerosisPatients with a clinically definitive diagnosis of MS, 0-5.5 Extended Disability Status Scale range.
Healthy individualsVoluntary healthy individuals with similar age and gender

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2 Minutes Walking Test

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

    Measured: baseline

  2. Timed Up and Go Test

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

    Measured: baseline

Secondary outcomes (10)

  1. Respiratory Functions Test

    Challenging vital capacity (FVC), forced expiratory volume in one second (FEV₁), forced expiratory volume in one second to forced vital capacity (FEV₁/FVC), peak flow rate (PEF), forced vital capacity 25-75% speed (FEF25-75%) will be measured by portable spirometry (Spirolab, Medical International Research, Rome, Italy).

    Measured: baseline

  2. Respiratory Muscle Strength

    Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using portable, electronic, oral pressure measuring device (Micro Medical MicroMPM, UK).

    Measured: baseline

  3. Trunk Impairment Scale

    Trunk impairment scale assesses static and dynamic sitting balance and trunk coordination. The maximum scores on the static sitting balance, dynamic sitting balance, and coordination subscales are 7, 10, and 6 points, respectively. The total score of Trunk impairment scale ranges between 0 and 23 points, with a higher score representing better trunk control.

    Measured: baseline

  4. Side Bridge Test (core muscles endurance)

    Subjects were asked to lie on their left or right sides and extend their legs straight. Then the subjects lift their hips off the ground and form a straight line with their bodies. The measurements are recorded with a chronometer as seconds. The tests end when the subjects break the test positions.

    Measured: baseline

  5. Modified Biering-Sorensen test (core muscles endurance)

    During the test, the subjects are placed in an exercise bed that extends outwardly from the leading edge of the upper body and ensures that the upper iliac spine is flush with the bench edge. Subjects are asked to raise their arms while maintaining body positions.Measurements are recorded in seconds with a stopwatch. The tests will end when the subjects break the test positions.

    Measured: baseline

  6. Trunk Flexion Test (core muscles endurance)

    Individuals are positioned in such a way that the body is at 60º, knees and hip at a flexion position of 90º. The evaluating physiotherapist supports the feet and fixes the feet on the floor. The measurements are recorded with a chronometer as seconds. The test is terminated when the 60 ° trunk flexion is impaired.

    Measured: baseline

  7. Prone bridge test (core muscles endurance)

    During the test, the subjects place their elbows on the floor as their starting position and open their feet around the width of their thighs. They keep their body straight without bending over their elbows and toes.The measurements are recorded with a chronometer as seconds. The tests end when the subjects break the test positions.

    Measured: baseline

  8. Sit-ups Test (core muscles power)

    The test is initiated when the subjects are told "start" and they are asked to flex their upper body up from the floor lifting the lower corner of the scapula from the floor.It is recorded how many times the subjects can perform each test for 30 seconds.

    Measured: baseline

  9. Modified Push-ups Test (core muscles power)

    In the push-ups test, the subjects are required to push their lower body until their elbows reach a 90° angle. They are then asked to extend their arms straight to return to the starting position.It is recorded how many times the subjects can perform each test for 30 seconds.

    Measured: baseline

  10. Lumbopelvic Stability Test

    Lumbopelvic stability is assessed using a stabilizer Pressure Biofeedback UnitTM (Chattanooga, Australia). With the participant lying supine on a plinth, the cushion is inflated underneath the participant's lumbar spine to 40 mmHg. Prior to testing, all participants are instructed in the "abdominal hollowing" manoeuvre that activates Transversus Abdominis muscle, and told to perform and continue the contraction this during subsequent lumbopelvic stability testing while attempting to minimize contraction of rectus abdominis. Scores are recorded as the highest level completed (0-5) with a pressure change no greater than 10 mmHg.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2019
  2. Study start4 Feb 2019
  3. Primary completion26 Jul 2019
  4. Study completion2 Aug 2019

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03826095
Sponsor's protocol ID
Assesment in MS
Status last verified
Aug 2019
First submitted
23 Jan 2019
Last updated
6 Aug 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25724874

  • 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.

    PubMed 1735276

  • 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.

    PubMed 3190505

  • 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.

    PubMed 15929512

  • 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.

    PubMed 10378547

  • 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.

    PubMed 1866003

  • 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.

    PubMed 17702701

  • 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.

    PubMed 14966714

  • 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.

    PubMed 25647356

  • 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.

    PubMed 26944709

  • 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.

    PubMed 12186831

  • 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.

    PubMed 5772056

  • 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.

    PubMed 7663792

  • 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.

    PubMed 16386063

  • 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.

    PubMed 21642370

Questions about this trial

What is this clinical trial studying?

An observational study of Physical Therapy, run by Hacettepe 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 6 inclusion and 2 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 6 Aug 2019. 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?

2 Minutes Walking Test (time frame: baseline). 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 NCT03826095, which also lists 18 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 6 Aug 2019.

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