Investigation of Factors Affecting Functional Capasity in Multiple Sclerosis

NCT06090084 | Unknown DMC

• 1 other identifier: 839-819
• Study Type: observational
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• The Mini Balance Evaluation Systems Test (Mini BESTest)

  The evaluation will take approximately 15 minutes.

• Evaluation of Core Muscles Strength

  The evaluation will take approximately 15 minutes.

• Evaluation of Trunk Muscle Structure

  The evaluation will take approximately 20 minutes.

• 5 Times Sit To Stand Test

  The evaluation will take approximately 3 minutes.

• Evaluation of Grip Force

  The evaluation will take approximately 5 minutes.

Study Arms (2)

Multiple Sclerosis

Multiple sclerosis patients

Other: Evaluation

Healthy Controls

Healthy subjects

Other: Evaluation

Interventions

Evaluation OTHER

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

Healthy Controls; Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multiple sclerosis patients and healthy controls

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Izmir Bakircay University: lead

Related Publications (3)

• 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.

  PMID: 25739555 BACKGROUND

• 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.

  PMID: 27372366 BACKGROUND

• 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.

  PMID: 22379256 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Yeşim Bakar

  İzmir Bakırçay University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gözde Kaya

CONTACT

+90 05432450621; gozde.kaya@bakircay.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: October 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10