Multiple SclerosisNCT03597451
The Effects of Muscles Strength on Physical Performance in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Muscle weakness, which is one of the most common symptoms in patients with MS, limits the activities of daily life activities of patients by causing balance and gait disturbance. Lower extremity muscle strengths of MS patients are reported to be weaker than healthy individuals. Broekmans et al. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Aug 2018to 6 Mar 2020
- 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
Who may be able to join
- Participants who 18-65 years of age
- MS patients who are ambulatory (Expanded Disability Status Scale score ≤ 5,5 ) in a stable phase of the disease, without relapses in the last 3 month.
Who cannot join
- Participants who have orthopedic, vision, hearing, or perception problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Extremity and "Core" Muscles Strength on Walking and Sit-to-Stand Performance in Patients With Multiple Sclerosis
Muscle weakness, which is one of the most common symptoms in patients with MS, limits the activities of daily life activities of patients by causing balance and gait disturbance. Lower extremity muscle strengths of MS patients are reported to be weaker than healthy individuals. Broekmans et al. showed that the weakness of the knee flexor and extensor muscles in patients with MS caused a decrease in walking distance and they are important determinants of walking capacity.
The effects of the endurance and strength of core muscles, as well as the extremity muscles, are important on physical performance. The weakness of the extremities and core muscles in MS patients also affects the sit-to-stand performance negatively as well as a decrease in walking speed and capacity.
In this study, it was aimed to investigate the effects of extremity and core muscle strength on walking and sitting-up performance of MS patients.
Read the detailed description
Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The strength of the extremity and core muscles, walking capacity, and sit-to-stand performance will be evaluated once.
Investigators will use descriptive statistics and t-tests to compare variables between groups. Investigators will examine the correlations between variables using Pearson bivariate correlations. The significance level is set at p<0,05
- Conditions
- Multiple Sclerosis
- Keywords
- strength, walking, sit-to-stand
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple sclerosis | Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) | |
| Control | Healthy individuals of similar age and sex to patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
strength of extremity muscles
The isometric strength of lower extremity muscles will be assessed respectively using a hand-held dynamometer (Baseline®, White Plains, New York, USA).
Measured: baseline
Secondary outcomes (7)
6 minutes walking test
The Six-Minute Walking Test (6MWT) was performed to determine walking capacity.
Measured: baseline
timed up and go test
Timed up and go test measures the time taken in seconds to arise from a standard chair, walk 3 m, turn through 180 degrees, walk back, and sit down again.
Measured: baseline
sit-to-stand test
In this test, the participants will stand up from and sit down on 43 cm high armless chair as quickly as possible 5 times.
Measured: baseline
Side Bridge Test (core muscles endurance)
The subjects were asked to lay on their left or right sides and to extend their legs fully. Then The subjects are asked to create a straight line with their body by lifting their hip from the floor.The measurements are recorded with a chronometer as seconds. The tests end when the subjects break the test positions.
Measured: baseline
Modified Biering-Sorensen test (core muscles endurance)
In this test, the subjects are asked to lie down on a workout bench, aligning their anterior superior iliac spine with the edge of the bench, which allowed the upper body to be planked out over the edge. The subjects are asked to fold their arms on their chest and to put their hands on their shoulders. The measurements are recorded with a chronometer as seconds. The tests end when the subjects break the test positions.
Measured: baseline
Trunk Flexion Test (core muscles endurance)
This test is initiated when the subjects are in a sit-up position with their back resting against a wedge that was angled 55° from the floor. The measurements are recorded with a chronometer as seconds. The tests end when the subjects break the test positions.
Measured: baseline
Prone bridge test (core muscles endurance)
In this test, the subjects put their elbows on the ground as the starting position and open their feet about the width of their hips while keeping their body straight as they are required not to arch or bow. The measurements are recorded with a chronometer as seconds. The tests end when the subjects break the test positions.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start13 Aug 2018
- Primary completion28 Feb 2020
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagla Ozkul, Gazi University
- Investigators
- Cagla Ozkul, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597451
- Sponsor's protocol ID
- 435
- Status last verified
- Apr 2020
- First submitted
- 9 Jul 2018
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yahia A, Ghroubi S, Mhiri C, Elleuch MH. Relationship between muscular strength, gait and postural parameters in multiple sclerosis. Ann Phys Rehabil Med. 2011 May;54(3):144-55. doi: 10.1016/j.rehab.2011.02.004. Epub 2011 Mar 9. English, French.
PubMed 21493176Broekmans T, Gijbels D, Eijnde BO, Alders G, Lamers I, Roelants M, Feys P. The relationship between upper leg muscle strength and walking capacity in persons with multiple sclerosis. Mult Scler. 2013 Jan;19(1):112-9. doi: 10.1177/1352458512444497. Epub 2012 May 4.
PubMed 22562952Ketelhut NB, Kindred JH, Manago MM, Hebert JR, Rudroff T. Core muscle characteristics during walking of patients with multiple sclerosis. J Rehabil Res Dev. 2015;52(6):713-24. doi: 10.1682/JRRD.2015.01.0006.
PubMed 26562753Fry 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 25647356Bliss 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.
PubMed 15907272
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Extremity and "Core" Muscles Strength on Walking and Sit-to-Stand Performance in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03597451
- Acronym / sponsor ID
- 435
- Conditions
- Multiple Sclerosis
- Keywords
- strength, walking, sit-to-stand
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 24 Jul 2018 (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.
Muscle weakness, which is one of the most common symptoms in patients with MS, limits the activities of daily life activities of patients by causing balance and gait disturbance. Lower extremity muscle strengths of MS patients are reported to be weaker than healthy individuals. Broekmans et al. showed that the weakness of the knee flexor and extensor muscles in patients with MS caused a decrease in walking distance and they are important determinants of walking capacity.
The effects of the endurance and strength of core muscles, as well as the extremity muscles, are important on physical performance. The weakness of the extremities and core muscles in MS patients also affects the sit-to-stand performance negatively as well as a decrease in walking speed and capacity.
In this study, it was aimed to investigate the effects of extremity and core muscle strength on walking and sitting-up performance of MS patients.
Detailed description
Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The strength of the extremity and core muscles, walking capacity, and sit-to-stand performance will be evaluated once.
Investigators will use descriptive statistics and t-tests to compare variables between groups. Investigators will examine the correlations between variables using Pearson bivariate correlations. The significance level is set at p<0,05
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis | – | –Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) |
| Control | – | –Healthy individuals of similar age and sex to patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- MS patients who are ambulatory
Key inclusion criteria (2 listed)
- Participants who 18-65 years of age
- MS patients who are ambulatory (Expanded Disability Status Scale score ≤ 5,5 ) in a stable phase of the disease, without relapses in the last 3 month.
Key exclusion criteria (1 listed)
- Participants who have orthopedic, vision, hearing, or perception problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
strength of extremity muscles
Time frame: baseline
The isometric strength of lower extremity muscles will be assessed respectively using a hand-held dynamometer (Baseline®, White Plains, New York, USA).
7 secondary outcomes
6 minutes walking test
Time frame: baseline
timed up and go test
Time frame: baseline
sit-to-stand test
Time frame: baseline
Side Bridge Test (core muscles endurance)
Time frame: baseline
Modified Biering-Sorensen test (core muscles endurance)
Time frame: baseline
Trunk Flexion Test (core muscles endurance)
Time frame: baseline
Prone bridge test (core muscles endurance)
Time frame: baseline
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 9 Apr 2020.
- Background: PubMed 21493176Yahia A, Ghroubi S, Mhiri C, Elleuch MH. Relationship between muscular strength, gait and postural parameters in multiple sclerosis. Ann Phys Rehabil Med. 2011 May;54(3):144-55. doi: 10.1016/j.rehab.2011.02.004. Epub 2011 Mar 9. English, French.
- Background: PubMed 22562952Broekmans T, Gijbels D, Eijnde BO, Alders G, Lamers I, Roelants M, Feys P. The relationship between upper leg muscle strength and walking capacity in persons with multiple sclerosis. Mult Scler. 2013 Jan;19(1):112-9. doi: 10.1177/1352458512444497. Epub 2012 May 4.
- Background: PubMed 26562753Ketelhut NB, Kindred JH, Manago MM, Hebert JR, Rudroff T. Core muscle characteristics during walking of patients with multiple sclerosis. J Rehabil Res Dev. 2015;52(6):713-24. doi: 10.1682/JRRD.2015.01.0006.
- Background: PubMed 25647356Fry 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.
- Background: PubMed 15907272Bliss 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.
- 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.
Cagla Ozkul principal investigator
Gazi 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 Multiple Sclerosis, run by Gazi 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 2 inclusion and 1 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 9 Apr 2020. 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?
strength of extremity muscles (time frame: baseline). 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 NCT03597451, which also lists 5 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 9 Apr 2020.