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

• Conditions: Multiple Sclerosis

• Registration Number: NCT04183751
• Lead Sponsor: Marmara University

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.

Detailed 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.

Study Timeline

• Study Start: 2019-04-21
• Status Verified: 2019-11
• Study First Submitted: 2019-11-28
• Study First Submitted QC: 2019-11-28
• Study First Posted: 2019-12-03
• Last Update Submitted: 2020-09-03
• Last Update Posted: 2020-09-04
• Primary Completion: 2020-12-21
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
International Physical Activity Questionnaire Short Form (IPAQ-SF)	7 days	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.
Berg Balance Scale (BBS)	7 days	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.
Fall Efficacy Scale (FES)	7 days	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.
Tampa Kinesiophobia Scale (TSK)	7 days	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.

Trial Locations

Locations (1)

Marmara University; 🇹🇷 Istanbul, Turkey