Investigation of Factors Affecting Functional Capasity in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Investigation of the Musculoskeletal and Respiratory System Factors Affecting Functional Capasity in Multiple Sclerosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06090084
• Other study ID #: 839-819
• Status: Not yet recruiting
• Start date: October 2023
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: Izmir Bakircay University
• Contact: Gözde Kaya
• Phone: +90 05432450621
• Email: gozde.kaya[@]bakircay.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Evaluation
Functional capacity, balance, core muscle strength, trunk muscle structure, lower extremity muscle strength, upper extremity functions, fatigue and respiratory muscle strength will be evaluated.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Bakircay University

References & Publications (3)

Freund 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. — View Citation

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. — View Citation

Wetzel 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 Minute Walk Test (6MWT)	The 6-minute walk test will be performed according to the procedure of Goldman et al. (2008).	The evaluation will take approximately 10 minutes.
Secondary	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.	The evaluation will take approximately 15 minutes.
Secondary	Evaluation of Core Muscles Strength	Pressure biofeedback device will be used to evaluate the activity of Transversus Abdominis (TrA) and Multifidus (M) muscles.	The evaluation will take approximately 15 minutes.
Secondary	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.	The evaluation will take approximately 20 minutes.
Secondary	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.	The evaluation will take approximately 3 minutes.
Secondary	Evaluation of Grip Force	Jamar® hydraulic hand dynamometer will be used to measure the grip force.	The evaluation will take approximately 5 minutes.
Secondary	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.	The evaluation will take approximately 5 minutes.
Secondary	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.	The evaluation will take approximately 5 minutes.
Secondary	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.	The evaluation will take approximately 15 minutes.