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Isokinetic Exercises in Patients With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT03779724
Recruitment Status : Completed
First Posted : December 19, 2018
Results First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Melek Aykut Selçuk, Aksaray University Training and Research Hospital

Brief Summary:
The investigators evaluated the effects of isokinetic muscle strengthening exercises of the quadriceps and hamstring on muscle strength, joint position sense, pain, kinesiophobia and quality of life in patients with multiple sclerosis.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: exercises Not Applicable

Detailed Description:

Objective: To evaluate the effects of isokinetic exercises on muscle strength, knee joint position sense, pain, kinesiophobia, and quality of life in patients with multiple sclerosis.

Design: Randomized controlled trial. Setting: Outpatient clinic. Participants: Fifty patients with multiple sclerosis. Interventions: Fifty patients who met the inclusion criteria were randomized to an isokinetic exercise (n:25) or home exercise programme (n:25). Sequentially numbered opaque envelopes were used for randomization.

Outcome measures: The outcome measures were the peak torque/body mass index of quadriceps and hamstring muscles at 60°/s and 180°/s velocities, the hamstring/quadriceps ratios at the same velocities, absolute angular errors of the 15°, 45°, and 60° and the mean absolute angular error of joint position sense of the less and more affected knees, and the scores of Multiple Sclerosis Quality of Life-54, Visual Analogue Scale, and Tampa Scale of Kinesiophobia.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This prospective randomized controlled trial aimed to recruit 50 patients with MS from the physical medicine and rehabilitation clinic of Ankara Training and Research Hospital, Health Sciences University, Ankara, Turkey. Fifty patients who met the inclusion criteria were enrolled in the study. Fifty patients were randomized to two groups: isokinetic exercise (Group 1) (n=25) and home exercise (Group 2) (n=25). Randomization was completed using sequentially numbered, opaque envelopes by the investigator. All patients gave informed consent before the assessment. The outcome measures were assessed initially and at eighth week after the treatment. Group 1 performed isokinetic concentric quadriceps and hamstring strengthening exercises under supervision and Group 2 performed lower extremity muscle strengthening and balance exercises at home.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Isokinetic Exercises on Muscle Strength, Joint Position Sense, and Kinesiophobia in Patients With Multiple Sclerosis: a Randomized Controlled Trial
Actual Study Start Date : July 29, 2015
Actual Primary Completion Date : July 29, 2016
Actual Study Completion Date : July 29, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: isokinetic exercise
The isokinetic dynamometer (Biodex Multijoint Pro 3) was used for isokinetic exercises. The isokinetic exercise program was implemented over eight weeks, twice a week on non-consecutive days under the supervision of a doctor. The number of repetitions undertaken by the patients over the program were as follows: first week 5 at 60°/s and 10 at 180°/s, second week 10 at 60°/s and 15 at 180°/s, third week 15 at 60°/s and 20 at 180°/s, fourth week 20 at 60°/s and 30 at 180°/s, and in the last four weeks 20 at 60°/s and 40 at 180°/s angular velocities. Each block of 10 repetitions were performed as a set.
Other: exercises
Active Comparator: home exercise
The patients undertook lower extremity strengthening and balance exercises three times a week for eight weeks without supervision. They started with three repetitions, which was gradually increased to 10-15. The patients were called two times a week to inquire about exercise continuity and encouraged to undertake the recommended exercises.
Other: exercises



Primary Outcome Measures :
  1. Isokinetic Muscle Strength Test of the More and Less Affected Knees [ Time Frame: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment ]
    The peak torque/body mass index of the quadriceps and hamstring muscles at 60°/s and 180°/s velocities were measured by an isokinetic dynamometer (Biodex Multijoint Pro 3) in Newton/meter. A definite muscle strength value has not been defined. Literally, healthy controls and patients are compared. Higher scores indicate better muscle strength.

  2. Joint Position Sense of the More and Less Affected Knees [ Time Frame: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment ]
    Absolute angular errors of the 15°, 45°, and 60° and the mean absolute angular error of the more and less affected knees were measured by an isokinetic dynamometer (Biodex Multijoint Pro 3) with active-active angular reproduction method. Estimating the target angel procedure was repeated at 45°, 15°, and 60° and for both the more and less affected legs. After the joint position sense testing, three angles estimated by the patients were averaged, and the angular error was calculated for each target angle. Absolute angular error was calculated by averaging the angular errors, regardless of the numbers being negative or positive. The absolute angular error values of the three target angles were averaged to obtain the mean absolute angular errors. A definite angular error value has not been defined. Literally, healthy controls and patients are compared. Higher scores indicate worser joint position sense.

  3. Tampa Scale of Kinesiophobia [ Time Frame: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment ]
    Kinesiophobia which is described as fear of movement and physical activity was evaluated using the Tampa Scale of Kinesiophobia, which is a 17-item self-report survey. The range of scores are from 17 to 68 where the higher scores indicate an increasing degree of kinesiophobia. If the total score was above 37 points, the patient was considered to have a high level of kinesiophobia.

  4. Multiple Sclerosis Quality of Life-54 Total Score, Physical and Emotional Composite Scores, and Pain Subscale Score [ Time Frame: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment ]
    This is a multidimensional health-related quality of life measure that combines both generic and multiple sclerosis-specific symptoms in a single instrument. The 54 items are divided into 12 multi-item and 2 single-item scales.Health distress, overall quality of life, emotional well-being, role limitations-emotional and cognitive funtion items' final scores averaged and mental composite score was calculated. Physical function, health perceptions, energy/fatigue, role limitations-physical, pain, sexual function, social function, health distress items' final scores were averaged and physical composite score was obtained.Total score was obtained by averaging the mental and physical composite scores.Final scores can be between 0-100 points for total, mental, physical and pain scores. Higher values indicate better quality of life for total, physical and mental scores and worser pain levels for pain score.

  5. Visual Analog Scale [ Time Frame: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment ]
    Pain intensity was evaluated with the Visual Analog Scale. Using a ruler, a 10 cm line was drawn which provided a range of scores from 0-100. Than the patients marked the point that showed their pain intensity on this line. A higher score in Visual Analog Scale indicates greater pain intensity.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • definite relapsing remitting MS and secondary progressive MS diagnosis
  • mild and moderate MS determined by Kurtzke Expanded Disability Status Scale (EDSS) scores below 6.5
  • a disease duration of more than one year.

Exclusion Criteria:

  • having an acute exacerbation within the last three months
  • intravenous pulse steroid therapy in the last four weeks
  • grade 3-4 spasticity according to the Modified Ashworth Scale
  • severe vision impairment
  • severe fatigue and depression
  • past knee surgery
  • other neurologic diseases
  • systemic diseases
  • pregnancy
  • having received an exercise program within the last four weeks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779724


Locations
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Turkey
Aksaray University Training and Research Hospital
Aksaray, Turkey
Ankara Training and Researc Hospital, Health Sciences University
Ankara, Turkey
Sponsors and Collaborators
Aksaray University Training and Research Hospital
Investigators
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Principal Investigator: Melek A Selçuk, MD Aksaray University Training and Research Hospital
  Study Documents (Full-Text)

Documents provided by Dr. Melek Aykut Selçuk, Aksaray University Training and Research Hospital:

Publications:
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Responsible Party: Dr. Melek Aykut Selçuk, Principal Investigator, Aksaray University Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03779724     History of Changes
Other Study ID Numbers: 5070
First Posted: December 19, 2018    Key Record Dates
Results First Posted: July 24, 2019
Last Update Posted: July 24, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Melek Aykut Selçuk, Aksaray University Training and Research Hospital:
multiple sclerosis
isokinetic
exercises
joint position sense
kinesiophobia
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases