Multiple SclerosisNCT06090084
Investigation of Factors Affecting Functional Capasity in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Izmir Bakircay University.
Trial summary
Functional exercise capacities of Multiple Sclerosis (MS) patients decrease with the effect of symptoms and sedentary lifestyle. A decrease in aerobic capacity may be manifested by a decrease in walking distance or speed, or by restriction in activities of daily living. 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?
- Evaluation
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Sep 2024
- 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
- Adult, Older adult
Study population: Multiple sclerosis patients and healthy controls
Who may be able to join
- Age between 18-65 years.
- Having MS diagnosed by a neurologist.
- Having a maximum score of 6.5 on the Expanded Disability Status Scale (EDSS).
- No change in medication in the last 6 months.
- Not having had an attack in the last 3 months.
- To be able to walk 100 meters independently
- To be able to read and write
Who cannot join
- Having another non-MS health problem that would preclude evaluations.
- Having a peripheral vestibular problem.
- Having a cardiopulmonary or orthopedic problem.
- Having a mental problem
- To have received physiotherapy and rehabilitation in the last 3 months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Investigation of the Musculoskeletal and Respiratory System Factors Affecting Functional Capasity in Multiple Sclerosis
Functional exercise capacities of Multiple Sclerosis (MS) patients decrease with the effect of symptoms and sedentary lifestyle. A decrease in aerobic capacity may be manifested by a decrease in walking distance or speed, or by restriction in activities of daily living. Decreased aerobic capacity is associated with many factors such as increased risk of cardiovascular disease, decline in cognitive functions, and decreased health-related quality of life. In this respect, measurement of aerobic capacity is one of the important physiological measurements in terms of evaluating the existing functional status of individuals and preparing rehabilitation programs appropriately for individuals. According to studies in the literature, functional capacity in MS patients has been found to be associated with many individual and disease-related factors. However, studies on musculoskeletal and respiratory system factors that may affect functional capacity are insufficient in number. The aim of this study is to examine the effects of balance, core muscle strength, trunk muscle structure, lower extremity muscle strength, upper extremity functions, fatigue and respiratory muscle strength on the functional capacities of MS patients.
Functional capacities of MS patients who met the inclusion criteria will be evaluated with the 6-Minute Walk Test, balance assessments with the Mini Balance Evaluation Systems Test, the strength of the core muscles with the pressurize biofeedback unit, the thickness of the trunk muscles by the Ultrasound Imaging Method, the muscle strength of the lower extremities with the 5 Times Sit to Stand Test, for upper extremity functions, grip strength will be evaluated with a hand dynamometer and Arm Functions Questionnaire in Multiple Sclerosis, fatigue with the Fatigue Severity Scale and respiratory muscle strength will be evaluated by measuring Maximal Inspiratory Pressure and Maximal Expiratory Pressure with an electronic pressure transducer.
The cumulative effects of the parameters to be evaluated on functional capacity in MS patients will be examined by multivariate linear regression analysis and the cumulative total variance will be obtained in terms of R2. Investigation of musculoskeletal system factors that may affect functional capacity and determining which factor contributes more will benefit clinicians and researchers working in this field in terms of evaluating patients and establishing rehabilitation programs.
Read the detailed description
Multiple Sclerosis (MS) is a chronic inflammatory disease of unknown etiology, characterized by demyelination, myelin damage, axonal loss and gliosis in the Central Nervous System (CNS). MS symptoms vary depending on the affected area in the CNS. Some of the clinical symptoms are: spasticity, fatigue, loss of muscle strength, tremor, balance problems, exercise intolerance, pain, sensory disorders, bladder and bowel problems, cognitive disorders, depression and sleep disorders. The symptoms seen in MS disease negatively affect the daily life activities of individuals and cause a decrease in their quality of life.
Cardiopulmonary fitness relates to the ability to perform dynamic, moderate to high-intensity exercise of large muscle groups for extended periods of time.
Performance in this type of exercise depends on the functional state of the cardiovascular, respiratory and musculoskeletal systems. Functional exercise capacity in MS patients is impaired compared to healthy individuals and is significantly associated with factors at all levels of the International Classification of Functioning, Disability and Health (ICF) model. A decrease in aerobic capacity may manifest itself as a decrease in walking distance or speed or a limitation in daily living activities. Decreased aerobic capacity is associated with many factors such as increased risk of cardiovascular disease, decline in cognitive functions and decrease in health-related quality of life. In this respect, aerobic capacity measurement is one of the important physiological measurements in terms of evaluating the existing functional status of individuals and preparing rehabilitation programs appropriately for individuals.
According to studies in the literature, functional capacity in MS patients has been found to be related to many individual-specific and disease-related factors. In addition, examining the musculoskeletal system factors that may affect functional capacity and investigating their contributions to functional capacity will be guiding in planning the rehabilitation programs of patients.
Studies investigating factors affecting functional capacity in MS patients are insufficient in number. In our study, the contributions of balance, core muscle strength, trunk muscle structure and upper extremity functions to functional capacity in MS patients will be investigated. Many factors that may be related to functional capacity have been investigated in the literature. However, it has been seen that there is a need for studies on the effects of these factors on functional capacity using regression models.
The aim of this study is to examine the effects of balance, core muscle strength, trunk muscle structure, lower extremity muscle strength, upper extremity functions, fatigue and respiratory muscle strength on the functional capacities of MS patients.
- Conditions
- Multiple Sclerosis
- Being tested
- Evaluation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvaluationOther
Functional capacity, balance, core muscle strength, trunk muscle structure, lower extremity muscle strength, upper extremity functions, fatigue and respiratory muscle strength will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis | Multiple sclerosis patients Receives: Other: Evaluation | |
| Healthy Controls | Healthy subjects Receives: Other: Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walk Test (6MWT)
The 6-minute walk test will be performed according to the procedure of Goldman et al. (2008).
Measured: The evaluation will take approximately 10 minutes.
Secondary outcomes (8)
The Mini Balance Evaluation Systems Test (Mini BESTest)
The Mini Balance Evaluation Systems Test (Mini BESTest) will be used in the evaluation of balance. Mini BESTest consists of 4 sub-titles, namely preparatory movement, reactive postural control, sensory orientation and dynamic walking, and a total of 14 items. Each subheading has its own overall rating. The total score of the preparatory movement, reactive postural control and sensory orientation is 6, and the total score of the dynamic walking subheading is 10. The highest score that can be obtained from the test is 28. As the score decreases, the physical condition worsens.
Measured: The evaluation will take approximately 15 minutes.
Evaluation of Core Muscles Strength
Pressure biofeedback device will be used to evaluate the activity of Transversus Abdominis (TrA) and Multifidus (M) muscles.
Measured: The evaluation will take approximately 15 minutes.
Evaluation of Trunk Muscle Structure
Trunk musculature will be examined using ultrasound imaging of the lateral abdominals (transversus abdominis, internal oblique, external oblique) and multifidus muscles.
Measured: The evaluation will take approximately 20 minutes.
5 Times Sit To Stand Test
The 5 times sit to stand test will be used to evaluate the general muscle strength of the lower extremity. It has been shown that this test gives information about the lower extremity muscle strength of MS patients. First, the participants are explained how the test is administered. Then the test is shown once. The participant, who sits in a chair with a height of 45 cm and a depth of 41 cm, without arm support, is told to stand up and sit down 5 times, not to sit back until their knees are fully extended each time they stand up, and to do the test as fast as they can. Before the test begins, participants are asked to place their arms crossed over their chest and maintain this position throughout the test. The test is repeated 3 minutes after the first application. The test result, which is completed in a shorter time than the results of these two applications, is used for statistical analysis. Time recording will be made with a manually controlled electronic stopwatch.
Measured: The evaluation will take approximately 3 minutes.
Evaluation of Grip Force
Jamar® hydraulic hand dynamometer will be used to measure the grip force.
Measured: The evaluation will take approximately 5 minutes.
The Arm Function in Multiple Sclerosis Questionnaire (AMSQ)
The Arm Function in Multiple Sclerosis Questionnaire is an MS-specific scale developed to evaluate upper extremity functions. It evaluates the limitation in activities of daily living related to arm function in the last 2 weeks in MS. The total score is obtained by adding up all the scores. The minimum score that can be obtained from the questionnaire is 31 points, and the maximum score is 186 points. As the score increases, the level of functionality decreases.
Measured: The evaluation will take approximately 5 minutes.
Fatigue Severity Scale
It will be used to evaluate the severity of fatigue. The scale has been shown to be valid and reliable in MS patients and in the Turkish population. It consists of 9 items. The Fatigue Severity Scale score is calculated by adding the scores of answers ranging from 1 to 7 given to nine items and averaging them. A high score indicates that the severity of fatigue increases.
Measured: The evaluation will take approximately 5 minutes.
Respiratory Muscle Strength Measurement
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be evaluated using an electronic pressure transducer. Respiratory muscle strength assessment will be done by spirometry according to American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) will be measured for assessment of respiratory muscles. The tests will be performed in a sitting position using a nose clip. The best of three successful measurements made will be recorded for further analysis.
Measured: The evaluation will take approximately 15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde KAYA, Izmir Bakircay University
- Investigators
- Yeşim Bakar, Principal investigator, İzmir Bakırçay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090084
- Sponsor's protocol ID
- 839-819
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Langeskov-Christensen M, Heine M, Kwakkel G, Dalgas U. Aerobic capacity in persons with multiple sclerosis: a systematic review and meta-analysis. Sports Med. 2015 Jun;45(6):905-23. doi: 10.1007/s40279-015-0307-x.
PubMed 25739555Freund JE, Stetts DM, Vallabhajosula S. Relationships between trunk performance, gait and postural control in persons with multiple sclerosis. NeuroRehabilitation. 2016 Jun 30;39(2):305-17. doi: 10.3233/NRE-161362.
PubMed 27372366Wetzel JL, Fry DK, Pfalzer LA. Six-minute walk test for persons with mild or moderate disability from multiple sclerosis: performance and explanatory factors. Physiother Can. 2011 Spring;63(2):166-80. doi: 10.3138/ptc.2009-62. Epub 2011 Apr 13.
PubMed 22379256
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Musculoskeletal and Respiratory System Factors Affecting Functional Capasity in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06090084
- Acronym / sponsor ID
- 839-819
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 19 Oct 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.
Functional exercise capacities of Multiple Sclerosis (MS) patients decrease with the effect of symptoms and sedentary lifestyle. A decrease in aerobic capacity may be manifested by a decrease in walking distance or speed, or by restriction in activities of daily living. Decreased aerobic capacity is associated with many factors such as increased risk of cardiovascular disease, decline in cognitive functions, and decreased health-related quality of life. In this respect, measurement of aerobic capacity is one of the important physiological measurements in terms of evaluating the existing functional status of individuals and preparing rehabilitation programs appropriately for individuals. According to studies in the literature, functional capacity in MS patients has been found to be associated with many individual and disease-related factors. However, studies on musculoskeletal and respiratory system factors that may affect functional capacity are insufficient in number. The aim of this study is to examine the effects of balance, core muscle strength, trunk muscle structure, lower extremity muscle strength, upper extremity functions, fatigue and respiratory muscle strength on the functional capacities of MS patients.
Functional capacities of MS patients who met the inclusion criteria will be evaluated with the 6-Minute Walk Test, balance assessments with the Mini Balance Evaluation Systems Test, the strength of the core muscles with the pressurize biofeedback unit, the thickness of the trunk muscles by the Ultrasound Imaging Method, the muscle strength of the lower extremities with the 5 Times Sit to Stand Test, for upper extremity functions, grip strength will be evaluated with a hand dynamometer and Arm Functions Questionnaire in Multiple Sclerosis, fatigue with the Fatigue Severity Scale and respiratory muscle strength will be evaluated by measuring Maximal Inspiratory Pressure and Maximal Expiratory Pressure with an electronic pressure transducer.
The cumulative effects of the parameters to be evaluated on functional capacity in MS patients will be examined by multivariate linear regression analysis and the cumulative total variance will be obtained in terms of R2. Investigation of musculoskeletal system factors that may affect functional capacity and determining which factor contributes more will benefit clinicians and researchers working in this field in terms of evaluating patients and establishing rehabilitation programs.
Detailed description
Multiple Sclerosis (MS) is a chronic inflammatory disease of unknown etiology, characterized by demyelination, myelin damage, axonal loss and gliosis in the Central Nervous System (CNS). MS symptoms vary depending on the affected area in the CNS. Some of the clinical symptoms are: spasticity, fatigue, loss of muscle strength, tremor, balance problems, exercise intolerance, pain, sensory disorders, bladder and bowel problems, cognitive disorders, depression and sleep disorders. The symptoms seen in MS disease negatively affect the daily life activities of individuals and cause a decrease in their quality of life.
Cardiopulmonary fitness relates to the ability to perform dynamic, moderate to high-intensity exercise of large muscle groups for extended periods of time.
Performance in this type of exercise depends on the functional state of the cardiovascular, respiratory and musculoskeletal systems. Functional exercise capacity in MS patients is impaired compared to healthy individuals and is significantly associated with factors at all levels of the International Classification of Functioning, Disability and Health (ICF) model. A decrease in aerobic capacity may manifest itself as a decrease in walking distance or speed or a limitation in daily living activities. Decreased aerobic capacity is associated with many factors such as increased risk of cardiovascular disease, decline in cognitive functions and decrease in health-related quality of life. In this respect, aerobic capacity measurement is one of the important physiological measurements in terms of evaluating the existing functional status of individuals and preparing rehabilitation programs appropriately for individuals.
According to studies in the literature, functional capacity in MS patients has been found to be related to many individual-specific and disease-related factors. In addition, examining the musculoskeletal system factors that may affect functional capacity and investigating their contributions to functional capacity will be guiding in planning the rehabilitation programs of patients.
Studies investigating factors affecting functional capacity in MS patients are insufficient in number. In our study, the contributions of balance, core muscle strength, trunk muscle structure and upper extremity functions to functional capacity in MS patients will be investigated. Many factors that may be related to functional capacity have been investigated in the literature. However, it has been seen that there is a need for studies on the effects of these factors on functional capacity using regression models.
The aim of this study is to examine the effects of balance, core muscle strength, trunk muscle structure, lower extremity muscle strength, upper extremity functions, fatigue and respiratory muscle strength on the functional capacities of MS patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis | – | Other: EvaluationMultiple sclerosis patients |
| Healthy Controls | – | Other: EvaluationHealthy subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Multiple sclerosis patients and healthy controls
Key inclusion criteria (7 listed)
- Age between 18-65 years.
- Having MS diagnosed by a neurologist.
- Having a maximum score of 6.5 on the Expanded Disability Status Scale (EDSS).
- No change in medication in the last 6 months.
- Not having had an attack in the last 3 months.
Key exclusion criteria (5 listed)
- Having another non-MS health problem that would preclude evaluations.
- Having a peripheral vestibular problem.
- Having a cardiopulmonary or orthopedic problem.
- Having a mental problem
- To have received physiotherapy and rehabilitation in the last 3 months.
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 |
|---|---|---|
| EvaluationFunctional capacity, balance, core muscle strength, trunk muscle structure, lower extremity muscle strength, upper extremity functions, fatigue and respiratory muscle strength will be evaluated. | Other | Healthy Controls, Multiple Sclerosis |
Primary outcome
6 Minute Walk Test (6MWT)
Time frame: The evaluation will take approximately 10 minutes.
The 6-minute walk test will be performed according to the procedure of Goldman et al. (2008).
8 secondary outcomes
The Mini Balance Evaluation Systems Test (Mini BESTest)
Time frame: The evaluation will take approximately 15 minutes.
Evaluation of Core Muscles Strength
Time frame: The evaluation will take approximately 15 minutes.
Evaluation of Trunk Muscle Structure
Time frame: The evaluation will take approximately 20 minutes.
5 Times Sit To Stand Test
Time frame: The evaluation will take approximately 3 minutes.
Evaluation of Grip Force
Time frame: The evaluation will take approximately 5 minutes.
The Arm Function in Multiple Sclerosis Questionnaire (AMSQ)
Time frame: The evaluation will take approximately 5 minutes.
Fatigue Severity Scale
Time frame: The evaluation will take approximately 5 minutes.
Respiratory Muscle Strength Measurement
Time frame: The evaluation will take approximately 15 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Background: PubMed 25739555Langeskov-Christensen M, Heine M, Kwakkel G, Dalgas U. Aerobic capacity in persons with multiple sclerosis: a systematic review and meta-analysis. Sports Med. 2015 Jun;45(6):905-23. doi: 10.1007/s40279-015-0307-x.
- Background: PubMed 27372366Freund JE, Stetts DM, Vallabhajosula S. Relationships between trunk performance, gait and postural control in persons with multiple sclerosis. NeuroRehabilitation. 2016 Jun 30;39(2):305-17. doi: 10.3233/NRE-161362.
- Background: PubMed 22379256Wetzel JL, Fry DK, Pfalzer LA. Six-minute walk test for persons with mild or moderate disability from multiple sclerosis: performance and explanatory factors. Physiother Can. 2011 Spring;63(2):166-80. doi: 10.3138/ptc.2009-62. Epub 2011 Apr 13.
- 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.
Yeşim Bakar principal investigator
İzmir Bakırçay University
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Izmir Bakircay 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 7 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gözde Kaya (+90 05432450621, gozde.kaya@bakircay.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute Walk Test (6MWT) (time frame: The evaluation will take approximately 10 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06090084, which also lists 3 linked publications.
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 23 Oct 2023.