Multiple Sclerosis, Relapsing-RemittingNCT03497468
Effects of Task-oriented Training on Functional Mobility and Fatigue in Patients With Multiple Sclerosis
A study testing Combined exercise training and Task-oriented training in people with Multiple Sclerosis, Relapsing-Remitting, run by Bezmialem Vakif University.
Trial summary
Multiple Sclerosis (MS) is inflammatory, demyelinating and autoimmune disease of the central nervous system. It is usually seen with relapses and genetic and environmental factors play a role in the etiology. Neurological symptoms seen in MS restrict the patient's daily activity and social role participation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Combined exercise training and Task-oriented training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2018
- 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
- Multiple Sclerosis diagnosis
- Expanded Disability Status Scale > 5,5
- No cognitive problems
- No relapses in the last 3 months
- No other neurological or chronic disease
Who cannot join
- Relapse during the intervention
- Exercise intolerance
About this study
Multiple Sclerosis (MS) is inflammatory, demyelinating and autoimmune disease of the central nervous system. It is usually seen with relapses and genetic and environmental factors play a role in the etiology. Neurological symptoms seen in MS restrict the patient's daily activity and social role participation. Mobility problems and fatigue are the most important reasons of role limitations and decreased quality of life. The importance of exercise training in disease management has been emphasized in recent years. However, few studies have investigated the effects of task-oriented trainings on symptoms of the disease. The aim of this sudy is to investigate the effects of task-oriented training additional to combined exercise training on functional capacity, mobility, balance, fatigue and quality of life in patients with MS.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Combined exercise training, Task-oriented training
- Keywords
- task-oriented training, exercise training, mobility, balance, fatigue, quality of life
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined exercise trainingOther
Aerobic training with cycle ergometer %60-80 of maximal Heart Rate, submaximal level, strengthening of the major muscles of upper and lower extremities
Task-oriented trainingOther
Functional reaching, walking on different obstacles and floor,sitting and standing on different levels and surface,walking around obstacle, climbing stairs with different height and surface
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients in this group will receive combined exercise training included aerobic and strengthening exercises, 3 times a week for 6 weeks. All exercise sessions will be performed under the supervision of a physiotherapist. Receives: Other: Combined exercise training |
| Training group | Experimental | Patients in this group will receive task-oriented training additional to combined exercise training 3 times a week for 6 weeks. Task-oriented training included more functional daily life mobility activities like reaching, obstacle walking, stairs climbing. All exercise sessions will be performed under the supervision of a physiotherapist. Receives: Other: Task-oriented training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
Change from baseline functional capacity with six minute walking test
Measured: 6 weeks
Secondary outcomes (8)
dynamic gait skills
Change from baseline functional mobility with dynamic gait index
Measured: 6 weeks
limitation of gait
Change from baseline functional mobility with MS walking scale-12
Measured: 6 weeks
dynamic balance and fall risk
Change from baseline functional mobility with timed up and go test
Measured: 6 weeks
sitatic balance
Change from baseline balance with functional reach test
Measured: 6 weeks
dynamic balance
Change from baseline balance with berg balance scale
Measured: 6 weeks
severity of fatigue
Change from baseline fatigue with fatigue severity scale
Measured: 6 weeks
impact of fatigue
Change from baseline fatigue with fatigue impact scale
Measured: 6 weeks
Quality of life
Change from baseline quality of life with MS quality of life instrument-54
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study startJan 2017
- Primary completion1 Dec 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamer Unal, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497468
- Sponsor's protocol ID
- kunal
- Status last verified
- Jun 2026
- First submitted
- 3 Apr 2018
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Task-oriented Training on Functional Mobility and Fatigue in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03497468
- Acronym / sponsor ID
- kunal
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- task-oriented training, exercise training, mobility, balance, fatigue, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 13 Apr 2018 (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 inflammatory, demyelinating and autoimmune disease of the central nervous system. It is usually seen with relapses and genetic and environmental factors play a role in the etiology. Neurological symptoms seen in MS restrict the patient's daily activity and social role participation. Mobility problems and fatigue are the most important reasons of role limitations and decreased quality of life. The importance of exercise training in disease management has been emphasized in recent years. However, few studies have investigated the effects of task-oriented trainings on symptoms of the disease. The aim of this sudy is to investigate the effects of task-oriented training additional to combined exercise training on functional capacity, mobility, balance, fatigue and quality of life in patients with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Combined exercise trainingPatients in this group will receive combined exercise training included aerobic and strengthening exercises, 3 times a week for 6 weeks. All exercise sessions will be performed under the supervision of a physiotherapist. |
| Training group | Experimental | Other: Task-oriented trainingPatients in this group will receive task-oriented training additional to combined exercise training 3 times a week for 6 weeks. Task-oriented training included more functional daily life mobility activities like reaching, obstacle walking, stairs climbing. All exercise sessions will be performed under the supervision of a physiotherapist. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Multiple Sclerosis diagnosis
- Expanded Disability Status Scale > 5,5
- No cognitive problems
- No relapses in the last 3 months
- No other neurological or chronic disease
Key exclusion criteria (2 listed)
- Relapse during the intervention
- Exercise intolerance
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 |
|---|---|---|
| Combined exercise trainingAerobic training with cycle ergometer %60-80 of maximal Heart Rate, submaximal level, strengthening of the major muscles of upper and lower extremities | Other | Control group |
| Task-oriented trainingFunctional reaching, walking on different obstacles and floor,sitting and standing on different levels and surface,walking around obstacle, climbing stairs with different height and surface | Other | Training group |
Primary outcome
Functional capacity
Time frame: 6 weeks
Change from baseline functional capacity with six minute walking test
8 secondary outcomes
dynamic gait skills
Time frame: 6 weeks
limitation of gait
Time frame: 6 weeks
dynamic balance and fall risk
Time frame: 6 weeks
sitatic balance
Time frame: 6 weeks
dynamic balance
Time frame: 6 weeks
severity of fatigue
Time frame: 6 weeks
impact of fatigue
Time frame: 6 weeks
Quality of life
Time frame: 6 weeks
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 1 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Combined exercise training and Task-oriented training in people with Multiple Sclerosis, Relapsing-Remitting, run by Bezmialem Vakif University.
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 5 inclusion and 2 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 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Functional capacity (time frame: 6 weeks). 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 1 Jul 2026.