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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Intervention Other: exercises
Enrollment 50
Recruitment Details This prospective randomized controlled trial aimed to recruit 50 patients with multiple sclerosis from the physical medicine and rehabilitation clinic of Ankara Training and Research Hospital, Health Sciences University, Ankara, Turkey.
Pre-assignment Details  
Arm/Group Title Isokinetic Exercise Home Exercise
Hide Arm/Group 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.

exercises

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.

exercises

Period Title: Overall Study
Started 25 25
Completed 19 21
Not Completed 6 4
Arm/Group Title Isokinetic Exercise Home Exercise Total
Hide Arm/Group 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.

exercises

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.

exercises

Total of all reporting groups
Overall Number of Baseline Participants 19 21 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 21 participants 40 participants
39.21  (8.81) 39.95  (12.25) 39.60  (10.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 21 participants 40 participants
Female
13
  68.4%
14
  66.7%
27
  67.5%
Male
6
  31.6%
7
  33.3%
13
  32.5%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Turkey Number Analyzed 19 participants 21 participants 40 participants
19
 100.0%
21
 100.0%
40
 100.0%
1.Primary Outcome
Title Isokinetic Muscle Strength Test of the More and Less Affected Knees
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Isokinetic Exercise Baseline Isokinetic Exercise After Treatment Home Exercise Baseline Home Exercise After Treatment
Hide Arm/Group 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.

exercises

the outcome measurements of isokinetic exercises group after the treatment

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.

exercises

the outcome measurements of home exercises group after the treatment
Overall Number of Participants Analyzed 19 19 21 21
Mean (Standard Deviation)
Unit of Measure: Newton/meter
60°/s Quadriceps PT/BMI(less affected knee) 110.48  (37.20) 141.05  (31.59) 123.02  (53.80) 127.83  (54.35)
60°/s Hamstring PT/BMI(less affected knee) 69.25  (24.28) 85.87  (21.00) 72.85  (29.02) 78.40  (31.21)
60°/s hamstring/quadriceps(less affected knee) 0.63  (0.14) 0.61  (0.12) 0.61  (0.14) 0.62  (0.12)
180°/s Quadriceps PT/BMI(less affected knee) 59.87  (24.51) 82.87  (23.11) 71.06  (32.01) 76.54  (28.73)
180°/s Hamstring PT/BMI(less affected knee) 46.74  (17.76) 56.85  (19.74) 53.73  (22.55) 56.76  (21.21)
180°/s hamstring/quadriceps (less affected knee) 0.80  (0.19) 0.69  (0.19) 0.76  (0.22) 0.74  (0.18)
60°/s Quadriceps PT/BMI(more affected knee) 82.46  (43.96) 118.50  (45.52) 100.16  (47.85) 108.06  (48.83)
60°/s Hamstring PT/BMI(more affected knee) 58.87  (33.60) 77.70  (29.27) 67.00  (30.87) 72.80  (31.55)
60°/s Hamstring/Quadriceps(more affected knee) 0.77  (0.27) 0.65  (0.12) 0.71  (0.22) 0.71  (0.22)
180°/s Quadriceps PT/BMI(more affected knee) 52.42  (25.08) 73.62  (23.53) 57.18  (30.59) 62.03  (29.38)
180°/s Hamstring PT/BMI(more affected knee) 42.25  (25.19) 51.38  (23.24) 46.19  (22.20) 48.08  (23.38)
180°/s Hamstring/Quadriceps(more affected knee) 0.92  (0.58) 0.66  (0.19) 0.94  (0.58) 0.85  (0.48)
2.Primary Outcome
Title Joint Position Sense of the More and Less Affected Knees
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Isokinetic Exercise Baseline Isokinetic Exercise After Treatment Home Exercise Baseline Home Exercise After Treatment
Hide Arm/Group 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.

exercises

the outcome measurements of isokinetic exercises group after the treatment

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.

exercises

the outcome measurements of home exercises group after the treatment
Overall Number of Participants Analyzed 19 19 21 21
Mean (Standard Deviation)
Unit of Measure: degree
mean absolute angular error of less affected knee 5.56  (2.78) 4.39  (2.32) 5.70  (3.19) 5.03  (2.65)
mean absolute angular error of lmore affected knee 4.94  (3.06) 4.38  (1.94) 5.76  (5.35) 4.99  (3.59)
15° joint position sense of less affected knee 6.26  (4.70) 3.87  (4.28) 5.93  (5.26) 5.32  (4.07)
15° joint position sense of more affected knee 4.61  (3.79) 0.74  (4.04) 4.96  (4.05) 5.27  (3.82)
45° joint position sense of less affected knee 6.41  (3.61) 5.86  (3.95) 6.23  (4.36) 4.94  (3.04)
45° joint position sense of more affected knee 4.73  (3.81) 4.21  (2.95) 5.80  (5.00) 5.46  (4.62)
60° joint position sense of less affected knee 3.40  (3.08) 3.39  (3.00) 4.55  (4.78) 3.76  (4.73)
60° joint position sense of more affected knee 6.02  (4.99) 4.17  (2.52) 4.18  (6.67) 3.47  (3.92)
3.Primary Outcome
Title Tampa Scale of Kinesiophobia
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Isokinetic Exercise Baseline Isokinetic Exercise After Treatment Home Exercise Baseline Home Exercise After Treatment
Hide Arm/Group 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.

exercises

the outcome measurements of isokinetic exercises group after the treatment

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.

exercises

the outcome measurements of home exercises group after the treatment
Overall Number of Participants Analyzed 19 19 21 21
Mean (Standard Deviation)
Unit of Measure: score on a scale
42.42  (5.48) 40.57  (7.25) 40.33  (6.37) 40.33  (7.72)
4.Primary Outcome
Title Multiple Sclerosis Quality of Life-54 Total Score, Physical and Emotional Composite Scores, and Pain Subscale Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Isokinetic Exercise Baseline Isokinetic Exercise After Treatment Home Exercise Baseline Home Exercise After Treatment
Hide Arm/Group 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.

exercises

the outcome measurements of isokinetic exercises group after the treatment

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.

exercises

the outcome measurements of home exercises group after the treatment
Overall Number of Participants Analyzed 19 19 21 21
Mean (Standard Deviation)
Unit of Measure: score on a scale
MSQoL-54 (total) 52.20  (17.98) 57.00  (18.95) 61.38  (18.54) 59.39  (20.93)
MSQoL-54 (physical) 50.79  (17.02) 54.69  (18.31) 58.64  (19.81) 56.69  (22.10)
MSQoL-54 (mental) 53.59  (20.71) 59.33  (21.81) 64.11  (20.41) 62.07  (22.78)
MSQoL-54 (pain) 54.52  (26.90) 58.57  (30.10) 71.74  (28.52) 67.83  (29.94)
5.Primary Outcome
Title Visual Analog Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Isokinetic Exercise Baseline Isokinetic Exercise After Treatment Home Exercise Baseline Home Exercise After Treatment
Hide Arm/Group 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.

exercises

the outcome measurements of isokinetic exercises group after the treatment

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.

exercises

the outcome measurements of home exercises group after the treatment
Overall Number of Participants Analyzed 19 19 21 21
Mean (Standard Deviation)
Unit of Measure: score on a scale
40.78  (34.16) 36.68  (36.66) 41.66  (31.11) 42.14  (29.13)
Time Frame adverse events were not monitored/assessed.
Adverse Event Reporting Description adverse events were not monitored/assessed.
 
Arm/Group Title Isokinetic Exercise Home Exercise
Hide Arm/Group 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.

exercises

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.

exercises

All-Cause Mortality
Isokinetic Exercise Home Exercise
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Isokinetic Exercise Home Exercise
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Isokinetic Exercise Home Exercise
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
The limitations of the study include the low number of patients, lower EDSS scores, lack of a long-term evaluation of isokinetic exercises, and absence of a healthy control group.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: The principal investigator
Organization: Aksaray University Training and Research Hospital
Phone: 905555289493
EMail: mlk.aykut@gmail.com
Layout table for additonal information
Responsible Party: Dr. Melek Aykut Selçuk, Aksaray University Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03779724     History of Changes
Other Study ID Numbers: 5070
First Submitted: December 11, 2018
First Posted: December 19, 2018
Results First Submitted: December 18, 2018
Results First Posted: July 24, 2019
Last Update Posted: July 24, 2019