Multiple SclerosisNCT04175418
The Effects of Two Different Types of Exercise Programs to Increase Physical Activity in Patients With MS
A study testing Supervised Exercise Program and Online Education Program in people with Multiple Sclerosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Multiple Sclerosis (MS) is a chronic, inflammatory, neurodegenerative, autoimmune disease of the central nervous system. It is thought that MS, which is one of the main causes of non-traumatic neurological dysfunction in young adults, affects approximately two and a half million people worldwide. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Supervised Exercise Program and Online Education Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 1 Feb 2021
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being diagnosed with Multiple Sclerosis
- Being between 25 and 60 age range
- Not having attacks during last 3 months
- Having ≤ 5.5 Expanded Disability Status Scale
- Not having received physiotherapy and rehabilitation sessions for at least 3 months
- Having internet access
Who cannot join
- Pregnancy
- Blurred vision
- Use of assistive devices for ambulation
- Having another diagnosis rather than Multiple Sclerosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, 34000
About this study
Official title: The Effects of a Supervised Exercise Program Versus Online Education Program to Increase Physical Activity in Patients With Multiple Sclerosis
Multiple Sclerosis (MS) is a chronic, inflammatory, neurodegenerative, autoimmune disease of the central nervous system. It is thought that MS, which is one of the main causes of non-traumatic neurological dysfunction in young adults, affects approximately two and a half million people worldwide. The annual cost caused by MS is reported to be between $ 8,528 and $ 54,244 per patient. Due to the destruction of the central nervous system, MS has a wide range of sensory, motor, cerebellar and cognitive dysfunctions. These dysfunctions may lead to a limitation of physical activity in people with MS. In addition, people with MS may limit their physical activity because they fear the worsening of their symptoms. Physical inactivity and sedentary life style are thought to be among the reasons that increase the risk of developing chronic diseases such as cancer, hypercholesterolemia, hypertension, arthritis, osteoporosis, obesity, type 2 diabetes, depression and cardiovascular diseases in people with MS. It is reported that these chronic diseases secondary to MS increase mortality by 1.7 times. In addition, these diseases have been associated with increased disability, decreased quality of life, and hospitalization. Physical inactivity can increase disability and mortality by aggravating health problems caused by the disease. For this reason, it is emphasized that there should be studies to increase physical activity in people with MS. Studies have shown that physical activity improves muscle strength, aerobic capacity, gait and balance and reduces fatigue in people with MS. In addition, it is stated that physical activity increases self-efficacy and improves positive perspective in patients with MS. When the literature is examined, it is seen that there are studies about physical activity in MS but they have methodological limitations. There are a limited number of studies on the effectiveness of the programs planned to increase the level of physical activity. The aim of our study was to investigate the effects of physical activity program and online training program on physical activity in patients with MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Supervised Exercise Program, Online Education Program
- Keywords
- Multiple Sclerosis, Rehabilitation, Physical Activity, 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 ProgramOther
The exercise program in this group includes aerobic (walking) training and exercises to strengthen the upper and lower extremities and trunk muscles.
Online Education ProgramOther
The exercise program in this group includes aerobic (walking) training and home exercises to strengthen the upper and lower extremities and trunk muscles.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Exercise Program Group | Experimental | Participants in the supervised exercise group were included to a program that consisted of 16 individual physiotherapist supervised sessions (two 60-minutes sessions/week), which were prepared to improve physical activity. Receives: Other: Supervised Exercise Program |
| Online Education Program Group | Experimental | Participants in the online education group were included to a program that consisted of 16 online sessions (two 60-minutes sessions/week), which were prepared to improve physical activity. Receives: Other: Online Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Leisure-Time Exercise Questionnaire
It is a self-reported leisure-time exercise questionnaire which consists of 2 parts. The first part seeks information about the number of times one engages in mild, moderate and strenuous leisure-time exercise bouts of at least 15 min duration in a typical week. The weekly frequency of mild, moderate and strenuous exercise bouts are multiplied by 3, 5, and 9 metabolic equivalents (METs) and the total score is recorded. Second part seeks information about frequency of activity which is long enough to work up sweat in a typical week.
Measured: 1-3 minutes
Pedometer
It is one of the objective methods used to evaluate physical activity. It is used to record the number of steps taken. The estimated step length is entered in the device and recorded as a step when the vertical swing of the body exceeds a certain threshold.
Measured: one week
Secondary outcomes (7)
6 Minute Walk Test
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked on a 30 meter course over a span of 6 minutes.
Measured: 6 minutes
Multiple Sclerosis Walking Scale-12
It is a scale consisting of 12 questions about mobility which is used to measure walking capacity. The limitations of walking in the last two weeks are questioned. Answers are scored between 1-5 (1 = almost none, 5 = excessive). A high score indicates that the ability to walk is affected or that the patient has difficulty in walking.
Measured: 3-5 minutes
Fatigue Severity Scale
It is a scale that evaluates the fatigue of MS patients in daily functions. The assessment consists of 9 questions, each question is scored between 1 (strongly disagree) to 7 (strongly agree). The result score is the average value of nine questions. High score indicates increased fatigue severity
Measured: 3-5 minutes
Multiple Sclerosis International Quality of Life Questionnaire
The scale consists of 31 questions in 6 sub-groups including physical status, symptoms, psychological status, self-esteem, relationship with friends, family and medical staff. The answers are scored between 0 and 5 and a score between 0 and100 is obtained. The higher the score, the higher the level of quality of life.
Measured: 5-7 minutes
Brief International Cognitive Assessment for MS
The Brief International Cognitive Assessment for MS is composed of 3 parts.In these parts, data processing speed, verbal memory, and visual memory are evaluated.
Measured: 15 minutes
Bioelectrical Impedance Analysis
It is a method that is based on measurement of body resistance with the aid of alternative electric current. Body components are calculated by this method.
Measured: 1-2 minutes
Muscle Strength Test
The isokinetic dynamometer and handheld dynamometer are used to assess muscle strength. In this study, the isokinetic dynamometer will be used to evaluate the knee extensor and flexor concentric muscle strength and the handheld dynamometer will be used to evaluate upper extremity muscle strength including arm flexors, abductors, elbow flexors and lower extremity muscle strength including hip flexors and abductors.
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start1 Nov 2019
- Primary completion8 Jan 2020
- Study completion1 Feb 2021
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.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Prof.Dr.Mazhar Osman Mental Health and Psychiatric Diseases Education, Research Hospital
- Responsible party
- Principal investigator, Gamze Öztürk, Istanbul University - Cerrahpasa
- Investigators
- Yonca Zenginler Yazgan, Ph.D, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175418
- Sponsor's protocol ID
- IU-C
- Status last verified
- Jun 2023
- First submitted
- 21 Nov 2019
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Supervised Exercise Program Versus Online Education Program to Increase Physical Activity in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04175418
- Acronym / sponsor ID
- IU-C
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Rehabilitation, Physical Activity, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Prof.Dr.Mazhar Osman Mental Health and Psychiatric Diseases Education, Research Hospital
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 25 Nov 2019 (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.
Multiple Sclerosis (MS) is a chronic, inflammatory, neurodegenerative, autoimmune disease of the central nervous system. It is thought that MS, which is one of the main causes of non-traumatic neurological dysfunction in young adults, affects approximately two and a half million people worldwide. The annual cost caused by MS is reported to be between $ 8,528 and $ 54,244 per patient. Due to the destruction of the central nervous system, MS has a wide range of sensory, motor, cerebellar and cognitive dysfunctions. These dysfunctions may lead to a limitation of physical activity in people with MS. In addition, people with MS may limit their physical activity because they fear the worsening of their symptoms. Physical inactivity and sedentary life style are thought to be among the reasons that increase the risk of developing chronic diseases such as cancer, hypercholesterolemia, hypertension, arthritis, osteoporosis, obesity, type 2 diabetes, depression and cardiovascular diseases in people with MS. It is reported that these chronic diseases secondary to MS increase mortality by 1.7 times. In addition, these diseases have been associated with increased disability, decreased quality of life, and hospitalization. Physical inactivity can increase disability and mortality by aggravating health problems caused by the disease. For this reason, it is emphasized that there should be studies to increase physical activity in people with MS. Studies have shown that physical activity improves muscle strength, aerobic capacity, gait and balance and reduces fatigue in people with MS. In addition, it is stated that physical activity increases self-efficacy and improves positive perspective in patients with MS. When the literature is examined, it is seen that there are studies about physical activity in MS but they have methodological limitations. There are a limited number of studies on the effectiveness of the programs planned to increase the level of physical activity. The aim of our study was to investigate the effects of physical activity program and online training program on physical activity in patients with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised Exercise Program Group | Experimental | Other: Supervised Exercise ProgramParticipants in the supervised exercise group were included to a program that consisted of 16 individual physiotherapist supervised sessions (two 60-minutes sessions/week), which were prepared to improve physical activity. |
| Online Education Program Group | Experimental | Other: Online Education ProgramParticipants in the online education group were included to a program that consisted of 16 online sessions (two 60-minutes sessions/week), which were prepared to improve physical activity. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being diagnosed with Multiple Sclerosis
- Being between 25 and 60 age range
- Not having attacks during last 3 months
- Having ≤ 5.5 Expanded Disability Status Scale
- Not having received physiotherapy and rehabilitation sessions for at least 3 months
Key exclusion criteria (4 listed)
- Pregnancy
- Blurred vision
- Use of assistive devices for ambulation
- Having another diagnosis rather than Multiple Sclerosis
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 ProgramThe exercise program in this group includes aerobic (walking) training and exercises to strengthen the upper and lower extremities and trunk muscles. | Other | Supervised Exercise Program Group |
| Online Education ProgramThe exercise program in this group includes aerobic (walking) training and home exercises to strengthen the upper and lower extremities and trunk muscles. | Other | Online Education Program Group |
Primary outcome
The Leisure-Time Exercise Questionnaire
Time frame: 1-3 minutes
It is a self-reported leisure-time exercise questionnaire which consists of 2 parts. The first part seeks information about the number of times one engages in mild, moderate and strenuous leisure-time exercise bouts of at least 15 min duration in a typical week. The weekly frequency of mild, moderate and strenuous exercise bouts are multiplied by 3, 5, and 9 metabolic equivalents (METs) and the total score is recorded. Second part seeks information about frequency of activity which is long enough to work up sweat in a typical week.
Pedometer
Time frame: one week
It is one of the objective methods used to evaluate physical activity. It is used to record the number of steps taken. The estimated step length is entered in the device and recorded as a step when the vertical swing of the body exceeds a certain threshold.
7 secondary outcomes
6 Minute Walk Test
Time frame: 6 minutes
Multiple Sclerosis Walking Scale-12
Time frame: 3-5 minutes
Fatigue Severity Scale
Time frame: 3-5 minutes
Multiple Sclerosis International Quality of Life Questionnaire
Time frame: 5-7 minutes
Brief International Cognitive Assessment for MS
Time frame: 15 minutes
Bioelectrical Impedance Analysis
Time frame: 1-2 minutes
Muscle Strength Test
Time frame: 45 minutes
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 22 Jun 2023.
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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, Ph.D study director
Istanbul University - Cerrahpasa
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 and Online Education Program 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 4 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 22 Jun 2023. 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?
The Leisure-Time Exercise Questionnaire (time frame: 1-3 minutes). The study lists 2 primary outcomes in all. 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 22 Jun 2023; AzTrials last refreshed its copy on 1 Nov 2026.