Multiple SclerosisNCT06210581
The Effects of Internet-Based and Supervised Exercise Programs in People With Multiple Sclerosis
A study testing Supervised Exercise Program Group and Internet Based Exercise Program Group in people with Multiple Sclerosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The main aim of this study is resarch and compare the effects of supervised exercise programs and internet-based exercise programs, which have started to benefit from their effects in recent years, known for not requiring conditions such as transportation distance, cost and time, on motor disorders and quality of life… 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?
- Supervised Exercise Program Group and Internet Based Exercise Program Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 May 2023to 5 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosed with MS by a neurologist
- Being between ages of 18-65
- Not having had an attack in the last 3 months
- The score of Expanded Disability Status Scale (EDSS) is 5.5- 7.5
- Not participating in a another physiotherapy and rehabilitation program
- Having internet access
Who cannot join
- Pregnancy
- Severe cognitive impairment that effects participating to rehabilitation
- The cardiopulmonary disease that will prevent aerobic exercise
- Having a major hearing and/or vision problem
- Having a major speech disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University- Cerrahpasa
Istanbul, Istanbul, 34100
About this study
Official title: Comparison of the Effects of Internet-Based and Supervised Exercise Programs in People With Multiple Sclerosis
The main aim of this study is resarch and compare the effects of supervised exercise programs and internet-based exercise programs, which have started to benefit from their effects in recent years, known for not requiring conditions such as transportation distance, cost and time, on motor disorders and quality of life in people with multiple sclerosis (MS). This study conducting for develop a new perspective on conventional physiotherapy and rehabilitation practices. Our study will be performed in people with MS with a high EDSS score, is seen as an important contribution for the literature.
Read the detailed description
The groups were included in exercise programs of 16 sessions in total, twice a week for 8 weeks. Exercise programs will consist of warm-up, aerobic exercises, strengthening exercises, balance exercises, breathing exercises, cooling and relaxation exercises. Exercise programs will be created by the physiotherapist and arranged every 2 weeks according to the patients' conditions. Patients who do not participate in the program 2 times in a row will be excluded from the study.
- Conditions
- Multiple Sclerosis
- Being tested
- Supervised Exercise Program Group, Internet Based Exercise Program Group
- Keywords
- Balance, Multiple Sclerosis, Exercise
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Exercise Program GroupOther
The exercise programs will performed with the physiotherapist. The treatment programs of the patients will start with warm-up exercises and continue with aerobic exercises. Strengthening exercises will be performed in lying, sitting and standing positions. Body weight or free weight will be used for strengthening exercises. Balance exercises will be performed in sitting and standing positions and will be performed with or without support according to the patients conditions. The treatment sessions will be terminated by performing relaxation exercises combined with stretching and breathing exercises.
Internet Based Exercise Program GroupOther
Patients who are in the internet-based exercise program group will register cite ''https://www.telenororehab.com /'' which is web- based physiotherapy program for exercises. After the first evaluation patients will be given a username and password to log in to the system.
Before starting the exercise programs, the pages on how patients can log in to the system, how they can reach the physiotherapist through the system and how they can find individual exercise programs will be shown before the study. After logging in to their own pages, patients will be able to access video-based exercise programs that have been specially prepared for them. Patients in the Internet-based exercise program group will also be given the same exercise programs as the supervised exercise program group. The entry-exit times of patients to the system and the duration of maintaining exercise programs will be controlled from the administrator section on the system.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | The treatment sessions will be terminated by performing relaxation exercises combined with stretching and breathing exercises. Receives: Other: Supervised Exercise Program Group |
| Group II | Other | Patients who are in the internet-based exercise program group will register cite ''https://www.telenororehab.com /'' which is web- based physiotherapy program for exercises. Receives: Other: Internet Based Exercise Program Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 Minutes Walk Test (2MWT) (The change between the initial value and the value after 2 months will be evaluated).
This test is performed for the assessment of walking endurance. The patient is informed about the test before starting the test. The distance that a person walks along a 25-meter corridor in 2 minutes is calculated in meters. During the test, patients who have tiredness and shortness of breath can have a rest.
Measured: Baseline and end of weeks 8.
Secondary outcomes (10)
Fatigue Severity Scale (FSS) (The change between the initial value and the value after 2 months will be evaluated).
It is a scale used for the evaluation of fatigue in MS patients. It consists of a total of 9 questions. A minimum of 1 and a maximum of 7 points can be scored from each question. The minimum score that can be obtained from the test is 9 the maximum score is 63. High scores mean that fatigue has increased. Validity and reliability studies have been conducted in Turkish MS patients of the FSS.
Measured: Baseline and end of weeks 8.
12 Item MS Walking Scale (MSWS- 12) (The change between the initial value and the value after 2 months will be evaluated).
It is used for evaluating walking ability in MS patients. This scale evaluates the limitations faced by MS patients in walking in the last two weeks. Situations such as loss of balance during walking, running, going up and down stairs, standing and walking, slowing down of walking are questioned. It is a Likert-type scale consisting of 12 questions. Each question score to between 1 and 5 points. The high scores indicate that the ability to walk is affected or that there is difficulty in walking.
Measured: Baseline and end of weeks 8.
Modified Falls Efficacy Scale (MFES) (The change between the initial value and the value after 2 months will be evaluated).
The MFES aims to assess the impact of a person's fear of falling on daily living activities. MFES is consist of 14 items (10 indoor and 4 outdoor activitiy) and every question can score to 0-10. Low scores indicates high fear of falling.
Measured: Baseline and end of weeks 8.
Canadian Occupational Performance Measure (COPM) (The change between the initial value and the value after 2 months will be evaluated).
COPM evaluates the activities that a person has difficulty doing in daily life between 1-10 points as activity performance and satisfaction score. At least one, up to 5 activities can be written, resulting in a total performance and satisfaction score. These scores are divided by the number of activities written, resulting in an average performance and satisfaction score. A validity and reliability study of the scale was conducted in individuals with MS.
Measured: Baseline and end of weeks 8.
Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) (The change between the initial value and the value after 2 months will be evaluated).
): It is a scale that assess the quality of life in MS patients. MusiQoL has 9 subgroups and 31 questions. During the evaluation, patients are asked to take into account their condition for the last 4 weeks. The answers to each question and the points that can be obtained; It is never/ Never (0 points), Rarely/ A little (1 point), Sometimes/ A little (2 points), Often/ A lot (3 points), Always/ Too much (4 points). The lowest score that can be taken from the scale is 0, the highest score is 124, and a high score indicates a low quality of life.
Measured: Baseline and end of weeks 8.
The Multiple Sclerosis Impact Scale (MSIS- 29) (The change between the initial value and the value after 2 months will be evaluated).
): It is a scale consisting of a total of 29 items that evaluate the consequences of symptoms and limitations caused by MS. It is a Likert type scale consisting of 5 points that evaluates the severity of symptoms such as fatigue, tremor, muscle spasm, personal care activities, sleep problems, concentration disorders. 1= having no problems at all, 2= having very few problems, 3= having moderate problems, 4= having severe problems, 5= having very severe problems. A total of at least 29 and a maximum of 145 points. A high score indicates a high amount of yeti loss.
Measured: Baseline and end of weeks 8.
Berg Balance Scale (BBS) (The change between the initial value and the value after 2 months will be evaluated).
BBS developed for the functional assessment of balance in adults. it consists of 14 divisions. Each section is scored 0 to 4 points. 0= cannot do the task, 4= does it independently. A minimum of 0 and a maximum of 56 points can be scored. Low scores indicate a balance disorder. 0-20 points indicate a balance disorder, 21-40 points indicate an acceptable balance, 41-56 points indicate the presence of a good balance. There is a validity and reliability study of the scale in MS patients.
Measured: Baseline and end of weeks 8.
5 Times Sit to Stand Test (5TSTS) (The change between the initial value and the value after 2 months will be evaluated).
The patient is asked to sit on a chair with his arms crossed in a way to hold the other shoulders. The patient is told to sit down and get up 5 times as fast as possible. The test is terminated as soon as the person's pelvic area comes into contact with the chair. Increased time indicates a disturbed balance. The test has validity in MS patients.
Measured: Baseline and end of weeks 8.
Timed 25- Foot Walk (T25- FW) (The change between the initial value and the value after 2 months will be evaluated).
It is used for the evaluation of walking speed in MS patients. the patient is asked to walk the distance of 7.62 meters (25 steps) as fast as possible. The time is calculated in seconds. The timed 25-step walking test is known as a very suitable test for evaluating walking speed in MS patients.
Measured: Baseline and end of weeks 8.
Timed Get up and Go Test (TUG) (The change between the initial value and the value after 2 months will be evaluated).
TUG used to measure the balance and functional capacities of MS patients. The patient is asked to sit on a chair and a distance of 3 meters is determined. It is requested that the patient be with a shoe that he always uses. The patient is asked to get up from the chair, walk this distance and sit in the chair again. At this time, the time is kept in seconds by the stopwatch. High test times means reduce balance and high risk of falling. Its use in individuals with MS has been shown to be reliable and valid.
Measured: Baseline and end of weeks 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start29 May 2023
- Primary completion29 Jan 2024
- Study completion5 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tahire Basak Demir, Istanbul University - Cerrahpasa
- Investigators
- Yonca ZENGINLER YAZGAN, Study chair, Istanbul University-Cerrahpasa Faculty of Health ScienceMurat KURTUNCU, Study chair, Istanbul University Faculty of Medicine Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210581
- Sponsor's protocol ID
- IUC2023-04
- Status last verified
- Sep 2026
- First submitted
- 8 Jan 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient's information will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Internet-Based and Supervised Exercise Programs in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06210581
- Acronym / sponsor ID
- IUC2023-04
- Conditions
- Multiple Sclerosis
- Keywords
- Balance, Multiple Sclerosis, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 29 May 2023 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 5 May 2024 (actual)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is resarch and compare the effects of supervised exercise programs and internet-based exercise programs, which have started to benefit from their effects in recent years, known for not requiring conditions such as transportation distance, cost and time, on motor disorders and quality of life in people with multiple sclerosis (MS). This study conducting for develop a new perspective on conventional physiotherapy and rehabilitation practices. Our study will be performed in people with MS with a high EDSS score, is seen as an important contribution for the literature.
Detailed description
The groups were included in exercise programs of 16 sessions in total, twice a week for 8 weeks. Exercise programs will consist of warm-up, aerobic exercises, strengthening exercises, balance exercises, breathing exercises, cooling and relaxation exercises. Exercise programs will be created by the physiotherapist and arranged every 2 weeks according to the patients' conditions. Patients who do not participate in the program 2 times in a row will be excluded from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Supervised Exercise Program GroupThe treatment sessions will be terminated by performing relaxation exercises combined with stretching and breathing exercises. |
| Group II | Other | Other: Internet Based Exercise Program GroupPatients who are in the internet-based exercise program group will register cite ''https://www.telenororehab.com /'' which is web- based physiotherapy program for exercises. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with MS by a neurologist
- Being between ages of 18-65
- Not having had an attack in the last 3 months
- The score of Expanded Disability Status Scale (EDSS) is 5.5- 7.5
- Not participating in a another physiotherapy and rehabilitation program
Key exclusion criteria (5 listed)
- Pregnancy
- Severe cognitive impairment that effects participating to rehabilitation
- The cardiopulmonary disease that will prevent aerobic exercise
- Having a major hearing and/or vision problem
- Having a major speech disorder
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 |
|---|---|---|
| Supervised Exercise Program GroupThe exercise programs will performed with the physiotherapist. The treatment programs of the patients will start with warm-up exercises and continue with aerobic exercises. Strengthening exercises will be performed in lying, sitting and standing positions. Body weight or free weight will be used for strengthening exercises. Balance exercises will be performed in sitting and standing positions and will be performed with or without support according to the patients conditions. The treatment sessions will be terminated by performing relaxation exercises combined with stretching and breathing exercises. | Other | Group I |
| Internet Based Exercise Program GroupPatients who are in the internet-based exercise program group will register cite ''https://www.telenororehab.com /'' which is web- based physiotherapy program for exercises. After the first evaluation patients will be given a username and password to log in to the system. Before starting the exercise programs, the pages on how patients can log in to the system, how they can reach the physiotherapist through the system and how they can find individual exercise programs will be shown before the study. After logging in to their own pages, patients will be able to access video-based exercise programs that have been specially prepared for them. Patients in the Internet-based exercise program group will also be given the same exercise programs as the supervised exercise program group. The entry-exit times of patients to the system and the duration of maintaining exercise programs will be controlled from the administrator section on the system. | Other | Group II |
Primary outcome
2 Minutes Walk Test (2MWT) (The change between the initial value and the value after 2 months will be evaluated).
Time frame: Baseline and end of weeks 8.
This test is performed for the assessment of walking endurance. The patient is informed about the test before starting the test. The distance that a person walks along a 25-meter corridor in 2 minutes is calculated in meters. During the test, patients who have tiredness and shortness of breath can have a rest.
10 secondary outcomes
Fatigue Severity Scale (FSS) (The change between the initial value and the value after 2 months will be evaluated).
Time frame: Baseline and end of weeks 8.
12 Item MS Walking Scale (MSWS- 12) (The change between the initial value and the value after 2 months will be evaluated).
Time frame: Baseline and end of weeks 8.
Modified Falls Efficacy Scale (MFES) (The change between the initial value and the value after 2 months will be evaluated).
Time frame: Baseline and end of weeks 8.
Canadian Occupational Performance Measure (COPM) (The change between the initial value and the value after 2 months will be evaluated).
Time frame: Baseline and end of weeks 8.
Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) (The change between the initial value and the value after 2 months will be evaluated).
Time frame: Baseline and end of weeks 8.
The Multiple Sclerosis Impact Scale (MSIS- 29) (The change between the initial value and the value after 2 months will be evaluated).
Time frame: Baseline and end of weeks 8.
Berg Balance Scale (BBS) (The change between the initial value and the value after 2 months will be evaluated).
Time frame: Baseline and end of weeks 8.
5 Times Sit to Stand Test (5TSTS) (The change between the initial value and the value after 2 months will be evaluated).
Time frame: Baseline and end of weeks 8.
Timed 25- Foot Walk (T25- FW) (The change between the initial value and the value after 2 months will be evaluated).
Time frame: Baseline and end of weeks 8.
Timed Get up and Go Test (TUG) (The change between the initial value and the value after 2 months will be evaluated).
Time frame: Baseline and end of weeks 8.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- ArticleLink provided by the sponsor.
- ArticleLink provided by the sponsor.
- ArticleLink provided by the sponsor.
- ArticleLink provided by the sponsor.
- ArticleLink provided by the sponsor.
- Individual participant dataSharing planned: No. Patient's information will not be shared.
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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.
Yonca ZENGINLER YAZGAN study chair
Istanbul University-Cerrahpasa Faculty of Health Science
Murat KURTUNCU study chair
Istanbul University Faculty of Medicine Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Exercise Program Group and Internet Based Exercise Program Group in people with Multiple Sclerosis, run by Istanbul University - Cerrahpasa at 1 site 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 6 inclusion and 5 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 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
2 Minutes Walk Test (2MWT) (The change between the initial value and the value after 2 months will be evaluated). (time frame: Baseline and end of weeks 8.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2026.