Multiple SclerosisNCT03255460
The Relationship Between Fatigue and Physical Activity Level in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Multiple sclerosis (MS) is a chronic, progressive and unpredictable disease of the central nervous system. In MS, various loss of strength, balance and gait disturbances arise in the central nervous system due to sensory and/or motor neuron degeneration. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Mar 2017to 4 Jul 2018
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Power analysis was performed using "G * Powerversion3.1 program" in order to determine the minimum number of subjects to be taken into operation. Accordingly, the number of participants in the study group (n) = 37 (α: 0.05, for power 80%) and in the control group (n) = 37).
Who may be able to join
- 18-65 years of age
- Having a diagnosis of "Multiple Sclerosis" by a specialist physician
- Relapse free in the last 3 mounts
- Having an ambulatory status (Expanded Disability Status Scale score ≤ 6 )
- No diagnosis of depression
Who cannot join
- Any cardiovascular, orthopedic, visual, hearing and perception problems that may affect the results of the research
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Ankara
About this study
Official title: Investigation of the Relationship Between Fatigue and Physical Activity Level in Patients With Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, progressive and unpredictable disease of the central nervous system. In MS, various loss of strength, balance and gait disturbances arise in the central nervous system due to sensory and/or motor neuron degeneration. These disorders lead to limitations in individual activities and participation.
Fatigue is as reported one of the most common first three symptoms among patients with MS and affects up to 80% of the patients. Fatigue is defined as the lack of physical and/or mental energy. Sometimes fatigue can reduce the quality of life by leaving other disorders behind. The most important effect of fatigue is that individuals reduce their physical activity levels. This can lead to the inactivity-related secondary problems being added to the findings of the disease. So the physical capacities of individuals may gradually decrease.
Read more
In the literature, there are many studies showing that the level of physical activity of individuals with MS is lower than in healthy individuals. When the investigators analyze the studies that investigate the relation between fatigue and physical activity levels, it is seen that there is the single study about this subject in the literature.
As a result, additional studies are needed to investigate the level of physical activity and the factors affecting it in individuals with MS. Therefore, the investigators planned this study to investigate the relationship between fatigue and physical activity levels in patients with MS.
Read the detailed description
According to sample size calculation 37 diagnosed Multiple Sclerosis patients and 37 healthy individuals will be included.The demographic characteristics of the participants initially will be taken and Expanded Disability Status Scale score of those of MS will be recorded. Then, fatigue severity and perception, physical activity level, balance, peripheral muscle strength, functional mobility, functional exercise capacity will be evaluated. Primary outcomes are fatigue and physical activity level; secondary outcomes are balance, peripheral muscle strength, functional mobility, functional exercise capacity.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Fatigue, Physical Activity, Exercise
- Medical subject headings
- Multiple Sclerosis, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis individuals | Multiple sclerosis patients included in this study. Inclusion and exclusion criteria were considered. | |
| Healthy individuals | Those without chronic disease were included in the study. Inclusion and exclusion criteria were considered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue severity
Fatigue Severity Scale
Measured: Five minutes
Fatigue
Fatigue Impact Scale
Measured: Eight minutes
Physical activity behavior
Evaluated using an ActiGraph (GT3X+)
Measured: Three days
Physical activity
International Physical Activity Questionnaire
Measured: Five minutes
Secondary outcomes (4)
Functional exercise capacity
Evaluated using 6-minute walking test
Measured: Fifteen minutes
Balance
Evaluated using Bio Sway [(BSS) Biodex Inc.,Shirley, New York]
Measured: Fifteen minutes
Functional Mobility
Evaluated using Time and Go test
Measured: Two minutes
Muscle strength
Evaluated using digital hand dynamometer
Measured: Fifteen minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start27 Mar 2017
- Primary completion4 Jul 2018
- Study completion4 Jul 2018
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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kader Eldemir, Gazi University
- Investigators
- Kader Çekim, Pt, Study chair, Research assistantArzu Güçlü Gündüz, Pt, Phd, Study director, Associate professorCeyla İrkeç, MD, Prof, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255460
- Sponsor's protocol ID
- Gazi 1
- Status last verified
- Mar 2021
- First submitted
- 12 Aug 2017
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is not a plan to make individual participant data but when the statistical analyses of all data are made, all results will be shared
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Fatigue and Physical Activity Level in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03255460
- Acronym / sponsor ID
- Gazi 1
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Fatigue, Physical Activity, Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 4 Jul 2018 (actual)
- Study completion
- 4 Jul 2018 (actual)
- First posted
- 21 Aug 2017 (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, progressive and unpredictable disease of the central nervous system. In MS, various loss of strength, balance and gait disturbances arise in the central nervous system due to sensory and/or motor neuron degeneration. These disorders lead to limitations in individual activities and participation.
Fatigue is as reported one of the most common first three symptoms among patients with MS and affects up to 80% of the patients. Fatigue is defined as the lack of physical and/or mental energy. Sometimes fatigue can reduce the quality of life by leaving other disorders behind. The most important effect of fatigue is that individuals reduce their physical activity levels. This can lead to the inactivity-related secondary problems being added to the findings of the disease. So the physical capacities of individuals may gradually decrease.
In the literature, there are many studies showing that the level of physical activity of individuals with MS is lower than in healthy individuals. When the investigators analyze the studies that investigate the relation between fatigue and physical activity levels, it is seen that there is the single study about this subject in the literature.
As a result, additional studies are needed to investigate the level of physical activity and the factors affecting it in individuals with MS. Therefore, the investigators planned this study to investigate the relationship between fatigue and physical activity levels in patients with MS.
Detailed description
According to sample size calculation 37 diagnosed Multiple Sclerosis patients and 37 healthy individuals will be included.The demographic characteristics of the participants initially will be taken and Expanded Disability Status Scale score of those of MS will be recorded. Then, fatigue severity and perception, physical activity level, balance, peripheral muscle strength, functional mobility, functional exercise capacity will be evaluated. Primary outcomes are fatigue and physical activity level; secondary outcomes are balance, peripheral muscle strength, functional mobility, functional exercise capacity.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis individuals | – | –Multiple sclerosis patients included in this study. Inclusion and exclusion criteria were considered. |
| Healthy individuals | – | –Those without chronic disease were included in the study. Inclusion and exclusion criteria were considered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Power analysis was performed using "G * Powerversion3.1 program" in order to determine the minimum number of subjects to be taken into operation. Accordingly, the number of participants in the study group (n) = 37 (α: 0.05, for power 80%) and in the control group (n) = 37).
Key inclusion criteria (5 listed)
- 18-65 years of age
- Having a diagnosis of "Multiple Sclerosis" by a specialist physician
- Relapse free in the last 3 mounts
- Having an ambulatory status (Expanded Disability Status Scale score ≤ 6 )
- No diagnosis of depression
Key exclusion criteria (1 listed)
- Any cardiovascular, orthopedic, visual, hearing and perception problems that may affect the results of the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fatigue severity
Time frame: Five minutes
Fatigue Severity Scale
Fatigue
Time frame: Eight minutes
Fatigue Impact Scale
Physical activity behavior
Time frame: Three days
Evaluated using an ActiGraph (GT3X+)
Physical activity
Time frame: Five minutes
International Physical Activity Questionnaire
4 secondary outcomes
Functional exercise capacity
Time frame: Fifteen minutes
Balance
Time frame: Fifteen minutes
Functional Mobility
Time frame: Two minutes
Muscle strength
Time frame: Fifteen 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 2 Apr 2021.
- related infoLink provided by the sponsor.
- related infoLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data but when the statistical analyses of all data are made, all results will be shared
Related trials for Multiple Sclerosis
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Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
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A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
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A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
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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.
Kader Çekim, Pt study chair
Research assistant
Arzu Güçlü Gündüz, Pt, Phd study director
Associate professor
Ceyla İrkeç, MD, Prof principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Gazi University 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 5 inclusion and 1 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 2 Apr 2021. 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?
Fatigue severity (time frame: Five minutes). The study lists 4 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 2 Apr 2021.