The Relationship Between Kinesiophobia, Physical Activity, Balance and Fear of Fall in MS Patients

NCT04183751 | Unknown

• 1 other identifier: 21.02.2019/33
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating and neurodegenerative disease of the central nervous system (CNS). MS usually progresses with attacks, sequelae after attacks because it severely restricts the quality of life in patients and leads to progressive disability (Frohman et al., 2006). Balance and coordination problems, decreasing of physical activity level and fall disorders are observed in patients with MS (Confavreux et al., 2014). When the literature was examined, a relationship was found between kinesiophobia, quality of life, physical activity level and pain in stroke patients. Physical activity level, balance, fear of falling and kinesiophobia which are frequently seen in patients with MS have not been studied. In this study, the relationship between kinesiophobia, physical activity, balance and fear of fall in MS patients will be investigated.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Kinesiophobia; Balance

Outcome Measures

Primary Outcomes (4)

• Tampa Kinesiophobia Scale (TSK)

  The Tampa Scale of Kinesiophobia (TSK) that was developed in 1990 is a 17 item scale originally developed to measure the fear of movement related to chronic lower back pain. The TSK consists of 17 questions.A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement.

  7 days

• International Physical Activity Questionnaire Short Form (IPAQ-SF)

  The International Physical Activity Questionnaire short-form (IPAQ-SF) is one of the most widely used self-report questionnaires to assess PA. IPAQ-SF is a self-report questionnaire that assesses PA in the last 7 days. Using the IPAQ-SF scoring system, the total number of days and minutes of PA were calculated for each participant as recommended in the IPAQ website. The IPAQ-SF records the activity in four intensity levels: sitting, walking, moderate intensity (e.g., leisure cycling), and vigorous intensity (e.g, running or aerobics). MET method was used to determine the level of physical activity. Standard values for these activities were established. The generated values are expressed as follows; Severe Physical Activity = 8.0 MET, Moderate Severe Physical Activity = 4.0 MET, Walking = 3.3 MET, Sitting = 1.5 MET. Using these values, daily and weekly physical activity levels are calculated.

  7 days

• Berg Balance Scale (BBS)

  The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. function. The scale consists of 14 items with a score between 0 and 4; A higher score indicates a better balance.

  7 days

• Fall Efficacy Scale (FES)

  The Falls Efficacy Scale (FES) is a ten-item test rated on a 10-point scale from not confident at all to completely confident. Questions are scored between 1 and 10 points. 1 means a lot of trust, 10 means no. A total score of 0 to 100 is obtained. If the total score is more than 70 points, there is fear of falling.

  7 days

Interventions

scale study OTHER

Forms and questionnaires will be used. The data will be collected by the researchers by face to face interview technique.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population of the study consists of patients with EDSS (Expanded Disability Status Scale) score of 3-5.5. When determining the sample size, the significance level was taken as 0.05 to calculate the statistical power and the direction of the hypothesis was processed in two ways. The power analysis effect size values of the research were based on the G Power program and similar previous studies. In this cross-sectional correlation study, it was found that at least 37 cases should be taken depending on the determined statistical power and effect size values.The sample was planned to be composed of 40 people who have applied to the Department of Neurology, Okmeydanı Hospital, who have met the inclusion criteria, have read and signed the information form.

You may qualify if:

• EDSS to be in the range of 3-5.5
• Being diagnosed with MS
• Being between 18-65 years
• To score above 23 from the mini mental test
• Volunteering for the study and having signed the information form

You may not qualify if:

• illiteracy
• Orthopedic and chronic diseases that may affect physical and cognitive status other than MS
• Having MS attack period

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

Related Publications (8)

• Confavreux C, Vukusic S. The clinical course of multiple sclerosis. Handb Clin Neurol. 2014;122:343-69. doi: 10.1016/B978-0-444-52001-2.00014-5.

  PMID: 24507525 BACKGROUND

• Vlaeyen JWS, Crombez G, Linton SJ. The fear-avoidance model of pain. Pain. 2016 Aug;157(8):1588-1589. doi: 10.1097/j.pain.0000000000000574. No abstract available.

  PMID: 27428892 BACKGROUND

• Wouters EJ, van Leeuwen N, Bossema ER, Kruize AA, Bootsma H, Bijlsma JW, Geenen R. Physical activity and physical activity cognitions are potential factors maintaining fatigue in patients with primary Sjogren's syndrome. Ann Rheum Dis. 2012 May;71(5):668-73. doi: 10.1136/ard.2011.154245. Epub 2011 Nov 25.

  PMID: 22121127 BACKGROUND

• Frohman EM, Racke MK, Raine CS. Multiple sclerosis--the plaque and its pathogenesis. N Engl J Med. 2006 Mar 2;354(9):942-55. doi: 10.1056/NEJMra052130. No abstract available.

  PMID: 16510748 BACKGROUND

• Stys PK, Zamponi GW, van Minnen J, Geurts JJ. Will the real multiple sclerosis please stand up? Nat Rev Neurosci. 2012 Jun 20;13(7):507-14. doi: 10.1038/nrn3275.

  PMID: 22714021 BACKGROUND

• Cattaneo D, Regola A, Meotti M. Validity of six balance disorders scales in persons with multiple sclerosis. Disabil Rehabil. 2006 Jun 30;28(12):789-95. doi: 10.1080/09638280500404289.

  PMID: 16754576 BACKGROUND

• Cameron MH, Lord S. Postural control in multiple sclerosis: implications for fall prevention. Curr Neurol Neurosci Rep. 2010 Sep;10(5):407-12. doi: 10.1007/s11910-010-0128-0.

  PMID: 20567946 BACKGROUND

• Motl RW, Putzki N, Pilutti LA, Cadavid D. Longitudinal changes in self-reported walking ability in multiple sclerosis. PLoS One. 2015 May 1;10(5):e0125002. doi: 10.1371/journal.pone.0125002. eCollection 2015.

  PMID: 25932911 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Kinesiophobia

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• SEMRA OGUZ, PhD

  Marmara University

  STUDY CHAIR

• SEDA KARACA, MsC

  Marmara University

  PRINCIPAL INVESTIGATOR

• ELIF UNAL, Dr

  Okmeydanı Hospital

  PRINCIPAL INVESTIGATOR

• CANAN BOLCU EMIR, Dr

  Okmeydanı Hospital

  PRINCIPAL INVESTIGATOR

• MINE GULDEN POLAT, Prof

  Marmara University

  STUDY DIRECTOR

Central Study Contacts

SEDA KARACA

CONTACT

05077743857; aisa.sed@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 3, 2019
• Study Start: April 21, 2019
• Primary Completion: December 21, 2020
• Study Completion: July 1, 2021
• Last Updated: September 4, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)