Multiple SclerosisNCT03779724
Isokinetic Exercises in Patients With Multiple Sclerosis
A study testing exercises in people with Multiple Sclerosis, run by Aksaray University Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 29 Jul 2015to 29 Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- other neurologic diseases
- systemic diseases
- pregnancy
- having received an exercise program within the last four weeks.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Aksaray University Training and Research Hospital
Aksaray
Ankara Training and Researc Hospital, Health Sciences University
Ankara
About this study
Official title: The Effects of Isokinetic Exercises on Muscle Strength, Joint Position Sense, and Kinesiophobia in Patients With Multiple Sclerosis: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- exercises
- Keywords
- multiple sclerosis, isokinetic, exercises, joint position sense, kinesiophobia
- Medical subject headings
- Multiple Sclerosis, Motor Activity, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercisesOther
| Study group | Role | What they receive |
|---|---|---|
| isokinetic exercise | Experimental | 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. Receives: Other: exercises |
| home exercise | Active comparator | 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. Receives: Other: exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment
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.
Measured: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment
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.
Measured: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment
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.
Measured: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment
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.
Measured: At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start29 Jul 2015
- Primary completion29 Jul 2016
- Study completion29 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aksaray University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Melek Aykut Selçuk, Aksaray University Training and Research Hospital
- Investigators
- Melek A Selçuk, MD, Principal investigator, Aksaray University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779724
- Sponsor's protocol ID
- 5070
- Status last verified
- Jul 2019
- First submitted
- 11 Dec 2018
- Last updated
- 24 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21493176Robineau 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.
PubMed 15664681Selcuk MA, Cakit BD, Ergun U. Effects of isokinetic exercises on balance, proprioception, quality of life, and kinesiophobia in multiple sclerosis. Neurodegener Dis Manag. 2026 Apr;16(2):163-172. doi: 10.1080/17582024.2025.2552599. Epub 2025 Sep 2.
PubMed 40891231
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Isokinetic Exercises on Muscle Strength, Joint Position Sense, and Kinesiophobia in Patients With Multiple Sclerosis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03779724
- Acronym / sponsor ID
- 5070
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, isokinetic, exercises, joint position sense, kinesiophobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aksaray University Training and Research HospitalUniversity, hospital or other
- Study start
- 29 Jul 2015 (actual)
- Primary completion
- 29 Jul 2016 (actual)
- Study completion
- 29 Jul 2016 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Posted 24 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| isokinetic exercise | Experimental | Other: exercisesThe 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. |
| home exercise | Active comparator | Other: exercisesThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercises | Other | home exercise, isokinetic exercise |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21493176Yahia 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.
- Background: PubMed 15664681Robineau 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.
- Derived from this study: PubMed 40891231Selcuk MA, Cakit BD, Ergun U. Effects of isokinetic exercises on balance, proprioception, quality of life, and kinesiophobia in multiple sclerosis. Neurodegener Dis Manag. 2026 Apr;16(2):163-172. doi: 10.1080/17582024.2025.2552599. Epub 2025 Sep 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melek A Selçuk, MD principal investigator
Aksaray University Training and Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercises in people with Multiple Sclerosis, run by Aksaray University Training and Research Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03779724, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.