The Effects of Muscles Strength on Physical Performance in Patients With Multiple Sclerosis

Sponsor
Gazi University (Other)
Overall Status
Completed
CT.gov ID
NCT03597451
Collaborator
(none)
87
1
18.8
4.6

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    87 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The Effects of Extremity and "Core" Muscles Strength on Walking and Sit-to-Stand Performance in Patients With Multiple Sclerosis
    Actual Study Start Date :
    Aug 13, 2018
    Actual Primary Completion Date :
    Feb 28, 2020
    Actual Study Completion Date :
    Mar 6, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. strength of extremity muscles [baseline]

      The isometric strength of lower extremity muscles will be assessed respectively using a hand-held dynamometer (Baseline®, White Plains, New York, USA).

    Secondary Outcome Measures

    1. 6 minutes walking test [baseline]

      The Six-Minute Walking Test (6MWT) was performed to determine walking capacity.

    2. timed up and go test [baseline]

      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.

    3. sit-to-stand test [baseline]

      In this test, the participants will stand up from and sit down on 43 cm high armless chair as quickly as possible 5 times.

    4. Side Bridge Test (core muscles endurance) [baseline]

      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.

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

      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.

    6. Trunk Flexion Test (core muscles endurance) [baseline]

      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.

    7. Prone bridge test (core muscles endurance) [baseline]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 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.

    Exclusion Criteria:
    • Participants who have orthopedic, vision, hearing, or perception problems

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gazi University Ankara Turkey

    Sponsors and Collaborators

    • Gazi University

    Investigators

    • Principal Investigator: Cagla Ozkul, Gazi University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Cagla Ozkul, Principal Investigator, Gazi University
    ClinicalTrials.gov Identifier:
    NCT03597451
    Other Study ID Numbers:
    • 435
    First Posted:
    Jul 24, 2018
    Last Update Posted:
    Apr 9, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cagla Ozkul, Principal Investigator, Gazi University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 9, 2020