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Isokinetic Exercises in Patients With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercises
Sponsored by
Aksaray University Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, isokinetic, exercises, joint position sense, kinesiophobia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aksaray University Training and Research Hospital
  • Ankara Training and Researc Hospital, Health Sciences University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

isokinetic exercise

home exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Isokinetic Muscle Strength Test of the More and Less Affected Knees
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.
Joint Position Sense of the More and Less Affected Knees
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.
Tampa Scale of Kinesiophobia
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.
Multiple Sclerosis Quality of Life-54 Total Score, Physical and Emotional Composite Scores, and Pain Subscale Score
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.
Visual Analog Scale
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.

Secondary Outcome Measures

Full Information

First Posted
December 11, 2018
Last Updated
July 23, 2019
Sponsor
Aksaray University Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03779724
Brief Title
Isokinetic Exercises in Patients With Multiple Sclerosis
Official Title
The Effects of Isokinetic Exercises on Muscle Strength, Joint Position Sense, and Kinesiophobia in Patients With Multiple Sclerosis: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 29, 2015 (Actual)
Primary Completion Date
July 29, 2016 (Actual)
Study Completion Date
July 29, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aksaray University Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, isokinetic, exercises, joint position sense, kinesiophobia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
isokinetic exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
home exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
exercises
Primary Outcome Measure Information:
Title
Isokinetic Muscle Strength Test of the More and Less Affected Knees
Description
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.
Time Frame
At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment
Title
Joint Position Sense of the More and Less Affected Knees
Description
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.
Time Frame
At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment
Title
Tampa Scale of Kinesiophobia
Description
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.
Time Frame
At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment
Title
Multiple Sclerosis Quality of Life-54 Total Score, Physical and Emotional Composite Scores, and Pain Subscale Score
Description
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.
Time Frame
At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment
Title
Visual Analog Scale
Description
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.
Time Frame
At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melek A Selçuk, MD
Organizational Affiliation
Aksaray University Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aksaray University Training and Research Hospital
City
Aksaray
Country
Turkey
Facility Name
Ankara Training and Researc Hospital, Health Sciences University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
21493176
Citation
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.
Results Reference
background
PubMed Identifier
15664681
Citation
Robineau S, Nicolas B, Gallien P, Petrilli S, Durufle A, Edan G, Rochcongar P. [Eccentric isokinetic strengthening in hamstrings of patients with multiple sclerosis]. Ann Readapt Med Phys. 2005 Feb;48(1):29-33. doi: 10.1016/j.annrmp.2004.04.005. French.
Results Reference
background

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Isokinetic Exercises in Patients With Multiple Sclerosis

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