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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04183751
• Other study ID #: 21.02.2019/33
• Status: Recruiting
• Start date: April 21, 2019
• Est. completion date: July 2021

Study information

• Verified date: November 2019
• Source: Marmara University
• Contact: SEDA KARACA
• Phone: 05077743857
• Email: aisa.sed[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Multiple sclerosis (MS) has significant heterogeneity in terms of signs-symptoms, clinical course and outcomes (Compston, 2014). The incidence of the disease increases after the age of 18 and reaches the highest level between the ages of 20-40 (average age 30). It is thought that MS affects approximately 2.1 million people worldwide with approximately 175,000 newly diagnosed cases each year and is among the most common causes of neurological disability in young adults (World Health Organization Press, 2008).

MS signs and symptoms can be classified as primary, secondary and tertiary. Primary signs and symptoms are vision problems (optic neuritis), sensory influences, spasticity, tremor, weakness, cognitive problems and decreased motor functions. Secondary ones occur as a result of primary signs and symptoms. Examples include decubitus ulcers, osteoporosis and muscle atrophy that may develop due to immobility, as well as low physical activity levels. The tertiary ones are related to psychological, social, occupational, personal and sexual problems that occur as a result of long-term chronic disease (Stys, 2012).

These findings and symptoms cause a decrease in the level of physical activity in patients. When physical activity conditions for MS are examined, there is reliable evidence that these patients have low levels of physical activity and spend more time in immobile postures. According to the studies, MS patients who participated in high levels of physical activity and spent time in mobile postures were found to have better mental health, better social functionality, less fatigue and lower early mortality rates compared to inactive ones. It is thought that the level of physical activity in MS may also be associated with improvements in health-related quality of life and stability of disease symptoms (Mothl, 2008; Motl et al., 2015).

75% of patients with MS report balance problems in the course of the disease. Impairment of proprioception and vibration senses and the influence of optic and vestibular tracts adversely affect balance in MS (Cattaneo et al., 2006). Impaired balance, worsening of the quality of life and the fear of falling can affect the patient. As a result, mobility and independence decrease and fall increase (Cameron et al., 2010). The main cause of injuries and fractures in MS groups is falls (Mothl et al., 2015).

Balance and fall problems in neurological diseases create kinesiophobia, which is defined as fear that leads to avoidance of activity in the patient, which leads to a decrease in functional capacity, release of movement in wrong patterns, and consequently a decrease in physical activity level. There is a strong correlation between the levels of kinesiophobia and physical activity in different patient groups (Wouters et al., 2011).

Kinesiophobia has been described as a fear of excessive, unrealistic re-injury that can be gained after painful injury, reducing physical movement and activity. Patients with kinesiophobia think that movement will cause injury again and cause additional pain. This situation leads to a decrease in physical fitness, avoidance of activity, functional disability and depression in the long term (Vlaeyen et al., 2016). Although studies on falls, balance and physical activity have been conducted in patients with MS, no study has been conducted to investigate the relationship between these parameters and kinesiophobia. From this point of view, the relationship between kinesiophobia and these variables in MS patients will be examined.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2021
• Est. primary completion date: December 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• illiteracy

• Orthopedic and chronic diseases that may affect physical and cognitive status other than MS

• Having MS attack period

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• scale study
Forms and questionnaires will be used. The data will be collected by the researchers by face to face interview technique.

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Frohman EM, Racke MK, Raine CS. Multiple sclerosis--the plaque and its pathogenesis. N Engl J Med. 2006 Mar 2;354(9):942-55. Review. — View Citation

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. — View Citation

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. Review. Erratum in: Nat Rev Neurosci. 2012 Aug;13(8):597. — View Citation

Vlaeyen JW, Crombez G, Linton SJ. The fear-avoidance model of pain. Pain. 2016 Aug;157(8):1588-9. doi: 10.1097/j.pain.0000000000000574. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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