Trial Outcomes & Findings for Isokinetic Exercises in Patients With Multiple Sclerosis (NCT NCT03779724)
NCT ID: NCT03779724
Last Updated: 2019-07-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment
Results posted on
2019-07-24
Participant Flow
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.
Participant milestones
| Measure |
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.
exercises
|
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.
exercises
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
19
|
21
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Isokinetic Exercise
n=19 Participants
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
|
Home Exercise
n=21 Participants
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
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.21 years
STANDARD_DEVIATION 8.81 • n=19 Participants
|
39.95 years
STANDARD_DEVIATION 12.25 • n=21 Participants
|
39.60 years
STANDARD_DEVIATION 10.63 • n=40 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=19 Participants
|
14 Participants
n=21 Participants
|
27 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=19 Participants
|
7 Participants
n=21 Participants
|
13 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
19 Participants
n=19 Participants
|
21 Participants
n=21 Participants
|
40 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatmentThe 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.
Outcome measures
| Measure |
Isokinetic Exercise Baseline
n=19 Participants
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
|
Isokinetic Exercise After Treatment
n=19 Participants
the outcome measurements of isokinetic exercises group after the treatment
|
Home Exercise Baseline
n=21 Participants
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
|
Home Exercise After Treatment
n=21 Participants
the outcome measurements of home exercises group after the treatment
|
|---|---|---|---|---|
|
Isokinetic Muscle Strength Test of the More and Less Affected Knees
180°/s Hamstring PT/BMI(more affected knee)
|
42.25 Newton/meter
Standard Deviation 25.19
|
51.38 Newton/meter
Standard Deviation 23.24
|
46.19 Newton/meter
Standard Deviation 22.20
|
48.08 Newton/meter
Standard Deviation 23.38
|
|
Isokinetic Muscle Strength Test of the More and Less Affected Knees
60°/s Quadriceps PT/BMI(less affected knee)
|
110.48 Newton/meter
Standard Deviation 37.20
|
141.05 Newton/meter
Standard Deviation 31.59
|
123.02 Newton/meter
Standard Deviation 53.80
|
127.83 Newton/meter
Standard Deviation 54.35
|
|
Isokinetic Muscle Strength Test of the More and Less Affected Knees
60°/s Hamstring PT/BMI(less affected knee)
|
69.25 Newton/meter
Standard Deviation 24.28
|
85.87 Newton/meter
Standard Deviation 21.00
|
72.85 Newton/meter
Standard Deviation 29.02
|
78.40 Newton/meter
Standard Deviation 31.21
|
|
Isokinetic Muscle Strength Test of the More and Less Affected Knees
60°/s hamstring/quadriceps(less affected knee)
|
0.63 Newton/meter
Standard Deviation 0.14
|
0.61 Newton/meter
Standard Deviation 0.12
|
0.61 Newton/meter
Standard Deviation 0.14
|
0.62 Newton/meter
Standard Deviation 0.12
|
|
Isokinetic Muscle Strength Test of the More and Less Affected Knees
180°/s Quadriceps PT/BMI(less affected knee)
|
59.87 Newton/meter
Standard Deviation 24.51
|
82.87 Newton/meter
Standard Deviation 23.11
|
71.06 Newton/meter
Standard Deviation 32.01
|
76.54 Newton/meter
Standard Deviation 28.73
|
|
Isokinetic Muscle Strength Test of the More and Less Affected Knees
180°/s Hamstring PT/BMI(less affected knee)
|
46.74 Newton/meter
Standard Deviation 17.76
|
56.85 Newton/meter
Standard Deviation 19.74
|
53.73 Newton/meter
Standard Deviation 22.55
|
56.76 Newton/meter
Standard Deviation 21.21
|
|
Isokinetic Muscle Strength Test of the More and Less Affected Knees
180°/s hamstring/quadriceps (less affected knee)
|
0.80 Newton/meter
Standard Deviation 0.19
|
0.69 Newton/meter
Standard Deviation 0.19
|
0.76 Newton/meter
Standard Deviation 0.22
|
0.74 Newton/meter
Standard Deviation 0.18
|
|
Isokinetic Muscle Strength Test of the More and Less Affected Knees
60°/s Quadriceps PT/BMI(more affected knee)
|
82.46 Newton/meter
Standard Deviation 43.96
|
118.50 Newton/meter
Standard Deviation 45.52
|
100.16 Newton/meter
Standard Deviation 47.85
|
108.06 Newton/meter
Standard Deviation 48.83
|
|
Isokinetic Muscle Strength Test of the More and Less Affected Knees
60°/s Hamstring PT/BMI(more affected knee)
|
58.87 Newton/meter
Standard Deviation 33.60
|
77.70 Newton/meter
Standard Deviation 29.27
|
67.00 Newton/meter
Standard Deviation 30.87
|
72.80 Newton/meter
Standard Deviation 31.55
|
|
Isokinetic Muscle Strength Test of the More and Less Affected Knees
60°/s Hamstring/Quadriceps(more affected knee)
|
0.77 Newton/meter
Standard Deviation 0.27
|
0.65 Newton/meter
Standard Deviation 0.12
|
0.71 Newton/meter
Standard Deviation 0.22
|
0.71 Newton/meter
Standard Deviation 0.22
|
|
Isokinetic Muscle Strength Test of the More and Less Affected Knees
180°/s Quadriceps PT/BMI(more affected knee)
|
52.42 Newton/meter
Standard Deviation 25.08
|
73.62 Newton/meter
Standard Deviation 23.53
|
57.18 Newton/meter
Standard Deviation 30.59
|
62.03 Newton/meter
Standard Deviation 29.38
|
|
Isokinetic Muscle Strength Test of the More and Less Affected Knees
180°/s Hamstring/Quadriceps(more affected knee)
|
0.92 Newton/meter
Standard Deviation 0.58
|
0.66 Newton/meter
Standard Deviation 0.19
|
0.94 Newton/meter
Standard Deviation 0.58
|
0.85 Newton/meter
Standard Deviation 0.48
|
PRIMARY outcome
Timeframe: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatmentAbsolute 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.
Outcome measures
| Measure |
Isokinetic Exercise Baseline
n=19 Participants
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
|
Isokinetic Exercise After Treatment
n=19 Participants
the outcome measurements of isokinetic exercises group after the treatment
|
Home Exercise Baseline
n=21 Participants
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
|
Home Exercise After Treatment
n=21 Participants
the outcome measurements of home exercises group after the treatment
|
|---|---|---|---|---|
|
Joint Position Sense of the More and Less Affected Knees
mean absolute angular error of less affected knee
|
5.56 degree
Standard Deviation 2.78
|
4.39 degree
Standard Deviation 2.32
|
5.70 degree
Standard Deviation 3.19
|
5.03 degree
Standard Deviation 2.65
|
|
Joint Position Sense of the More and Less Affected Knees
mean absolute angular error of lmore affected knee
|
4.94 degree
Standard Deviation 3.06
|
4.38 degree
Standard Deviation 1.94
|
5.76 degree
Standard Deviation 5.35
|
4.99 degree
Standard Deviation 3.59
|
|
Joint Position Sense of the More and Less Affected Knees
15° joint position sense of less affected knee
|
6.26 degree
Standard Deviation 4.70
|
3.87 degree
Standard Deviation 4.28
|
5.93 degree
Standard Deviation 5.26
|
5.32 degree
Standard Deviation 4.07
|
|
Joint Position Sense of the More and Less Affected Knees
15° joint position sense of more affected knee
|
4.61 degree
Standard Deviation 3.79
|
0.74 degree
Standard Deviation 4.04
|
4.96 degree
Standard Deviation 4.05
|
5.27 degree
Standard Deviation 3.82
|
|
Joint Position Sense of the More and Less Affected Knees
45° joint position sense of less affected knee
|
6.41 degree
Standard Deviation 3.61
|
5.86 degree
Standard Deviation 3.95
|
6.23 degree
Standard Deviation 4.36
|
4.94 degree
Standard Deviation 3.04
|
|
Joint Position Sense of the More and Less Affected Knees
45° joint position sense of more affected knee
|
4.73 degree
Standard Deviation 3.81
|
4.21 degree
Standard Deviation 2.95
|
5.80 degree
Standard Deviation 5.00
|
5.46 degree
Standard Deviation 4.62
|
|
Joint Position Sense of the More and Less Affected Knees
60° joint position sense of less affected knee
|
3.40 degree
Standard Deviation 3.08
|
3.39 degree
Standard Deviation 3.00
|
4.55 degree
Standard Deviation 4.78
|
3.76 degree
Standard Deviation 4.73
|
|
Joint Position Sense of the More and Less Affected Knees
60° joint position sense of more affected knee
|
6.02 degree
Standard Deviation 4.99
|
4.17 degree
Standard Deviation 2.52
|
4.18 degree
Standard Deviation 6.67
|
3.47 degree
Standard Deviation 3.92
|
PRIMARY outcome
Timeframe: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatmentKinesiophobia 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.
Outcome measures
| Measure |
Isokinetic Exercise Baseline
n=19 Participants
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
|
Isokinetic Exercise After Treatment
n=19 Participants
the outcome measurements of isokinetic exercises group after the treatment
|
Home Exercise Baseline
n=21 Participants
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
|
Home Exercise After Treatment
n=21 Participants
the outcome measurements of home exercises group after the treatment
|
|---|---|---|---|---|
|
Tampa Scale of Kinesiophobia
|
42.42 score on a scale
Standard Deviation 5.48
|
40.57 score on a scale
Standard Deviation 7.25
|
40.33 score on a scale
Standard Deviation 6.37
|
40.33 score on a scale
Standard Deviation 7.72
|
PRIMARY outcome
Timeframe: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatmentThis 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.
Outcome measures
| Measure |
Isokinetic Exercise Baseline
n=19 Participants
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
|
Isokinetic Exercise After Treatment
n=19 Participants
the outcome measurements of isokinetic exercises group after the treatment
|
Home Exercise Baseline
n=21 Participants
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
|
Home Exercise After Treatment
n=21 Participants
the outcome measurements of home exercises group after the treatment
|
|---|---|---|---|---|
|
Multiple Sclerosis Quality of Life-54 Total Score, Physical and Emotional Composite Scores, and Pain Subscale Score
MSQoL-54 (total)
|
52.20 score on a scale
Standard Deviation 17.98
|
57.00 score on a scale
Standard Deviation 18.95
|
61.38 score on a scale
Standard Deviation 18.54
|
59.39 score on a scale
Standard Deviation 20.93
|
|
Multiple Sclerosis Quality of Life-54 Total Score, Physical and Emotional Composite Scores, and Pain Subscale Score
MSQoL-54 (physical)
|
50.79 score on a scale
Standard Deviation 17.02
|
54.69 score on a scale
Standard Deviation 18.31
|
58.64 score on a scale
Standard Deviation 19.81
|
56.69 score on a scale
Standard Deviation 22.10
|
|
Multiple Sclerosis Quality of Life-54 Total Score, Physical and Emotional Composite Scores, and Pain Subscale Score
MSQoL-54 (mental)
|
53.59 score on a scale
Standard Deviation 20.71
|
59.33 score on a scale
Standard Deviation 21.81
|
64.11 score on a scale
Standard Deviation 20.41
|
62.07 score on a scale
Standard Deviation 22.78
|
|
Multiple Sclerosis Quality of Life-54 Total Score, Physical and Emotional Composite Scores, and Pain Subscale Score
MSQoL-54 (pain)
|
54.52 score on a scale
Standard Deviation 26.90
|
58.57 score on a scale
Standard Deviation 30.10
|
71.74 score on a scale
Standard Deviation 28.52
|
67.83 score on a scale
Standard Deviation 29.94
|
PRIMARY outcome
Timeframe: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatmentPain 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.
Outcome measures
| Measure |
Isokinetic Exercise Baseline
n=19 Participants
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
|
Isokinetic Exercise After Treatment
n=19 Participants
the outcome measurements of isokinetic exercises group after the treatment
|
Home Exercise Baseline
n=21 Participants
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
|
Home Exercise After Treatment
n=21 Participants
the outcome measurements of home exercises group after the treatment
|
|---|---|---|---|---|
|
Visual Analog Scale
|
40.78 score on a scale
Standard Deviation 34.16
|
36.68 score on a scale
Standard Deviation 36.66
|
41.66 score on a scale
Standard Deviation 31.11
|
42.14 score on a scale
Standard Deviation 29.13
|
Adverse Events
Isokinetic Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Home Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
The principal investigator
Aksaray University Training and Research Hospital
Phone: 905555289493
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place