Clinical trial NCT06090084: Investigation of Factors Affecting Functional Capasity in Multiple Sclerosis
Official title: Investigation of the Musculoskeletal and Respiratory System Factors Affecting Functional Capasity in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Multiple Sclerosis
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple sclerosis patients and healthy controls

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 6 Minute Walk Test (6MWT)
timeFrame: The evaluation will take approximately 10 minutes.
Secondary outcomes:
measure: The Mini Balance Evaluation Systems Test (Mini BESTest)
timeFrame: The evaluation will take approximately 15 minutes.
measure: Evaluation of Core Muscles Strength
timeFrame: The evaluation will take approximately 15 minutes.
measure: Evaluation of Trunk Muscle Structure
timeFrame: The evaluation will take approximately 20 minutes.
measure: 5 Times Sit To Stand Test
timeFrame: The evaluation will take approximately 3 minutes.
measure: Evaluation of Grip Force
timeFrame: The evaluation will take approximately 5 minutes.
measure: The Arm Function in Multiple Sclerosis Questionnaire (AMSQ)
timeFrame: The evaluation will take approximately 5 minutes.
measure: Fatigue Severity Scale
timeFrame: The evaluation will take approximately 5 minutes.
measure: Respiratory Muscle Strength Measurement
timeFrame: The evaluation will take approximately 15 minutes.
Other outcomes:
Locations:
Study officials:
affiliation: İzmir Bakırçay University
name: Yeşim Bakar
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.