Multiple SclerosisNCT05697523
Multiple Sclerosis and Respiratory and Functional Capacity
An observational study of Multiple Sclerosis, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
It is known that respiratory functions, physical activities and functional capacities of Multiple Sclerosis (MS) patients decrease with the progression of the disease. However, there is not enough information about the severity of the effects of these parameters in mild Relapsing-Remitting Multiple Sclerosis (RRMS)… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Expanded Disability Status Scale, pulmonary function test, International Physical Activity Questionnaire - Short Form, 6 minute walk test
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Jan 2021
- How long will I take part?
- 1 Day
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Multiple Sclerosis patients who applied to Pamukkale University Hospital Neurology Clinic were included in this study.
Patient group - Inclusion Criteria:
- Having a definitive diagnosis of RRMS according to the 2017 McDonald criteria
- Being between the ages of 18-60.
- To be willing to participate in the study.
- EDSS score between 0-3.
Healthy group - Inclusion Criteria:
- Being between the ages of 18-60.
- To be willing to participate in the study.
Patient group - Exclusion Criteria:
- Have other neurological, orthopedic and systemic problems
- Having a relapse 30 days before or during the study
- Changes in medication use in the past 30 days
Healthy group - Exclusion Criteria:
- Have neurological, orthopedic and systemic problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Respiratory, Physical Activity and Functional Capacities of Patients wıth Mild Relapsing Remitting Multiple Sclerosis and Healthy Controls
It is known that respiratory functions, physical activities and functional capacities of Multiple Sclerosis (MS) patients decrease with the progression of the disease. However, there is not enough information about the severity of the effects of these parameters in mild Relapsing-Remitting Multiple Sclerosis (RRMS) patients. Our aim in this study is to compare the respiratory functions, physical activities and functional capacities of mild RRMS patients with healthy controls and to examine the relationship between them.
Read the detailed description
It is known that respiratory functions, physical activities and functional capacities of Multiple Sclerosis (MS) patients decrease with the progression of the disease. However, there is not enough information about the severity of the effects of these parameters in mild Relapsing-Remitting Multiple Sclerosis (RRMS) patients. Our aim in this study is to compare the respiratory functions, physical activities and functional capacities of mild RRMS patients with healthy controls and to examine the relationship between them.
Forty individuals diagnosed with RRMS between the ages of 18-60 and 40 healthy individuals with similar demographic characteristics were included in the study.
- Conditions
- Multiple Sclerosis
- Being tested
- Expanded Disability Status Scale, pulmonary function test, International Physical Activity Questionnaire - Short Form, 6 minute walk test
- Keywords
- Multiple Sclerosis, functional capacity, physical activity, respiratory system, Relapsing-Remitting
- 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.
Expanded Disability Status Scale, pulmonary function test, International Physical Activity Questionnaire - Short Form, 6 minute walk testOther
Expanded Disability Status Scale, pulmonary function test, International Physical Activity Questionnaire - Short Form, 6 minute walk test
| Study group | Role | What they receive |
|---|---|---|
| Patient group | people with mild RRMS Receives: Other: Expanded Disability Status Scale, pulmonary function test, International Physical Activity Questionnaire - Short Form, 6 minute walk test | |
| Healthy group | healthy people Receives: Other: Expanded Disability Status Scale, pulmonary function test, International Physical Activity Questionnaire - Short Form, 6 minute walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function Tests- FEV1/FVC
Evaluation of FEV1/FVC ratio MicroQuark® computer-based USB spirometer will be used to assess the respiratory function of the participants. The person will be asked to take a few normal breaths followed by as deep a breath as possible and instructed to exhale forcefully and quickly without waiting. The test will be terminated by instructing the participant to take a deep breath after exhaling for at least six seconds.
Measured: Baseline
Pulmonary Function Tests- FVC
Evaluation of Forced Vital Capacity (FVC) MicroQuark® computer-based USB spirometer will be used for FVC evaluation. The person will be asked to take a few normal breaths, then take as deep a breath as possible, and then exhale forcefully and quickly without waiting. The test will be terminated by instructing the participant to take a deep breath after exhaling for at least six seconds.
Measured: Baseline
Pulmonary Function Tests- FEV1
Evaluation of Forced Expiratory Volume in 1 second (FEV1) MicroQuark® computer-based USB spirometer will be used for FEV1 evaluation. The person will be asked to take a few normal breaths, then take as deep a breath as possible, and then exhale forcefully and quickly without waiting. The test will be terminated by instructing the participant to take a deep breath after exhaling for at least six seconds.
Measured: Baseline
Pulmonary Function Tests- PEF
Evaluation of Peak Expiratory Flow (PEF) MicroQuark® computer-based USB spirometer will be used for PEF evaluation. The person will be asked to take a few normal breaths, then take as deep a breath as possible, and then exhale forcefully and quickly without waiting. The test will be terminated by instructing the participant to take a deep breath after exhaling for at least six seconds.
Measured: Baseline
Pulmonary Function Tests- MVV
Maximum voluntary ventilation (MVV) MicroQuark® computer-based USB spirometer will be used for MVV evaluation. Then the participant will take the disposable bacteria filter mouthpiece between his lips and holds it tightly. The person will be asked to deeply and rapidly breaths for 10 to 15 seconds.
Measured: Baseline
Functional Capacity
The 6-minute walk test (6MWT) was used to measure functional capacity. In the test, the participant was asked to walk for 6 minutes as fast as possible in a 30-meter corridor, and the total distance in meters was recorded. Standard encouragement was given to the participant every 60 seconds during the test. Estimated values of participants For men; (7.57 x height(cm)) - (5.02 x age) - (1.76 x kg) - 309, for women; Calculated with the formula (2.11 x height(cm)) - (2.29 x kg) - (5.78 x age) + 667.
Measured: Baseline
International Physical Activity Questionnaire - Short Form
The International Physical Activity Questionnaire-Short Form (IPAQ-SF) was used to evaluate physical activity. It was developed to evaluate the physical activities of people between the ages of 15-60 in their daily lives. It consists of seven questions in total and questions the time spent in vigorous, moderate-to-severe and walking activities. In addition, the sitting time is considered as a separate question. The Metabolic Equivalent (MET-minute) score is determined at the end of the calculation made by multiplying the MET value of the activities performed by the minute. Classification is based on the numerical data obtained. Accordingly, there are 3 activity levels: Inactive, minimal active and very active. The lowest level of physical activity is inactive and the highest level of physical activity is very active. The IPAQ is a valid and reliable test in MS patients.
Measured: Baseline
Secondary outcomes (1)
Expanded Disability Status Scale
The Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The scale is based on a neurological examination by a clinician. It has steps from 0 to 10. The higher scores indicate higher neurological disability.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Jan 2020
- Primary completion1 Jan 2021
- Study completion1 Jan 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Collaborators
- Pamukkale University
- Responsible party
- Principal investigator, Gürkan Demirtas, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697523
- Sponsor's protocol ID
- 60116787-020/92286
- Status last verified
- Jan 2023
- First submitted
- 12 Jan 2023
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Respiratory, Physical Activity and Functional Capacities of Patients wıth Mild Relapsing Remitting Multiple Sclerosis and Healthy Controls
- ClinicalTrials.gov ID
- NCT05697523
- Acronym / sponsor ID
- 60116787-020/92286
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, functional capacity, physical activity, respiratory system, Relapsing-Remitting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Collaborators
- Pamukkale University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 26 Jan 2023 (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.
It is known that respiratory functions, physical activities and functional capacities of Multiple Sclerosis (MS) patients decrease with the progression of the disease. However, there is not enough information about the severity of the effects of these parameters in mild Relapsing-Remitting Multiple Sclerosis (RRMS) patients. Our aim in this study is to compare the respiratory functions, physical activities and functional capacities of mild RRMS patients with healthy controls and to examine the relationship between them.
Detailed description
It is known that respiratory functions, physical activities and functional capacities of Multiple Sclerosis (MS) patients decrease with the progression of the disease. However, there is not enough information about the severity of the effects of these parameters in mild Relapsing-Remitting Multiple Sclerosis (RRMS) patients. Our aim in this study is to compare the respiratory functions, physical activities and functional capacities of mild RRMS patients with healthy controls and to examine the relationship between them.
Forty individuals diagnosed with RRMS between the ages of 18-60 and 40 healthy individuals with similar demographic characteristics were included in the study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | Other: Expanded Disability Status Scale, pulmonary function test, International Physical Activity Questionnaire - Short Form, 6 minute walk testpeople with mild RRMS |
| Healthy group | – | Other: Expanded Disability Status Scale, pulmonary function test, International Physical Activity Questionnaire - Short Form, 6 minute walk testhealthy people |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Multiple Sclerosis patients who applied to Pamukkale University Hospital Neurology Clinic were included in this study.
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 |
|---|---|---|
| Expanded Disability Status Scale, pulmonary function test, International Physical Activity Questionnaire - Short Form, 6 minute walk testExpanded Disability Status Scale, pulmonary function test, International Physical Activity Questionnaire - Short Form, 6 minute walk test | Other | Healthy group, Patient group |
Primary outcome
Pulmonary Function Tests- FEV1/FVC
Time frame: Baseline
Evaluation of FEV1/FVC ratio MicroQuark® computer-based USB spirometer will be used to assess the respiratory function of the participants. The person will be asked to take a few normal breaths followed by as deep a breath as possible and instructed to exhale forcefully and quickly without waiting. The test will be terminated by instructing the participant to take a deep breath after exhaling for at least six seconds.
Pulmonary Function Tests- FVC
Time frame: Baseline
Evaluation of Forced Vital Capacity (FVC) MicroQuark® computer-based USB spirometer will be used for FVC evaluation. The person will be asked to take a few normal breaths, then take as deep a breath as possible, and then exhale forcefully and quickly without waiting. The test will be terminated by instructing the participant to take a deep breath after exhaling for at least six seconds.
Pulmonary Function Tests- FEV1
Time frame: Baseline
Evaluation of Forced Expiratory Volume in 1 second (FEV1) MicroQuark® computer-based USB spirometer will be used for FEV1 evaluation. The person will be asked to take a few normal breaths, then take as deep a breath as possible, and then exhale forcefully and quickly without waiting. The test will be terminated by instructing the participant to take a deep breath after exhaling for at least six seconds.
Pulmonary Function Tests- PEF
Time frame: Baseline
Evaluation of Peak Expiratory Flow (PEF) MicroQuark® computer-based USB spirometer will be used for PEF evaluation. The person will be asked to take a few normal breaths, then take as deep a breath as possible, and then exhale forcefully and quickly without waiting. The test will be terminated by instructing the participant to take a deep breath after exhaling for at least six seconds.
Pulmonary Function Tests- MVV
Time frame: Baseline
Maximum voluntary ventilation (MVV) MicroQuark® computer-based USB spirometer will be used for MVV evaluation. Then the participant will take the disposable bacteria filter mouthpiece between his lips and holds it tightly. The person will be asked to deeply and rapidly breaths for 10 to 15 seconds.
Functional Capacity
Time frame: Baseline
The 6-minute walk test (6MWT) was used to measure functional capacity. In the test, the participant was asked to walk for 6 minutes as fast as possible in a 30-meter corridor, and the total distance in meters was recorded. Standard encouragement was given to the participant every 60 seconds during the test. Estimated values of participants For men; (7.57 x height(cm)) - (5.02 x age) - (1.76 x kg) - 309, for women; Calculated with the formula (2.11 x height(cm)) - (2.29 x kg) - (5.78 x age) + 667.
International Physical Activity Questionnaire - Short Form
Time frame: Baseline
The International Physical Activity Questionnaire-Short Form (IPAQ-SF) was used to evaluate physical activity. It was developed to evaluate the physical activities of people between the ages of 15-60 in their daily lives. It consists of seven questions in total and questions the time spent in vigorous, moderate-to-severe and walking activities. In addition, the sitting time is considered as a separate question. The Metabolic Equivalent (MET-minute) score is determined at the end of the calculation made by multiplying the MET value of the activities performed by the minute. Classification is based on the numerical data obtained. Accordingly, there are 3 activity levels: Inactive, minimal active and very active. The lowest level of physical activity is inactive and the highest level of physical activity is very active. The IPAQ is a valid and reliable test in MS patients.
1 secondary outcome
Expanded Disability Status Scale
Time frame: Baseline
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 26 Jan 2023.
- Individual participant dataSharing planned: No
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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.
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 Nigde Omer Halisdemir 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?
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 26 Jan 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?
Pulmonary Function Tests- FEV1/FVC (time frame: Baseline). The study lists 7 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 26 Jan 2023.