Multiple SclerosisNCT04183751
The Relationship Between Kinesiophobia, Physical Activity, Balance and Fear of Fall in MS Patients
An observational study of Multiple Sclerosis, run by Marmara University at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- scale study
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Apr 2019to Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- illiteracy
- Orthopedic and chronic diseases that may affect physical and cognitive status other than MS
- Having MS attack period
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University
Istanbul, 34000
SEDA KARACA, 00 90 507 ext. 7743857, aisa.sed@gmail.com
About this study
Official title: The Relationship Between Kinesiophobia, Physical Activity, Balance and Fear of Fall in Multiple Sclerosis Patients
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- scale study
- Keywords
- Multiple Sclerosis, Kinesiophobia, Balance
- Medical subject headings
- Multiple Sclerosis, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scale studyOther
Forms and questionnaires will be used. The data will be collected by the researchers by face to face interview technique.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start21 Apr 2019
- Primary completion21 Dec 2020 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SEMRA OGUZ, PhD, Study chair, Marmara UniversitySEDA KARACA, MsC, Principal investigator, Marmara UniversityELIF UNAL, Dr, Principal investigator, Okmeydanı HospitalCANAN BOLCU EMIR, Dr, Principal investigator, Okmeydanı HospitalMINE GULDEN POLAT, Prof, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183751
- Sponsor's protocol ID
- 21.02.2019/33
- Status last verified
- Nov 2019
- First submitted
- 28 Nov 2019
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24507525Vlaeyen 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.
PubMed 27428892Wouters 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.
PubMed 22121127Frohman 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.
PubMed 16510748Stys 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.
PubMed 22714021Cattaneo 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.
PubMed 16754576Cameron 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.
PubMed 20567946Motl 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.
PubMed 25932911
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Kinesiophobia, Physical Activity, Balance and Fear of Fall in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT04183751
- Acronym / sponsor ID
- 21.02.2019/33
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Kinesiophobia, Balance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 21 Apr 2019 (actual)
- Primary completion
- 21 Dec 2020 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- illiteracy
- Orthopedic and chronic diseases that may affect physical and cognitive status other than MS
- Having MS attack period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| scale studyForms and questionnaires will be used. The data will be collected by the researchers by face to face interview technique. | Other | – |
Primary outcome
Tampa Kinesiophobia Scale (TSK)
Time frame: 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.
International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Background: PubMed 24507525Confavreux 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.
- Background: PubMed 27428892Vlaeyen 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.
- Background: PubMed 22121127Wouters 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.
- Background: PubMed 16510748Frohman 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.
- Background: PubMed 22714021Stys 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.
- Background: PubMed 16754576Cattaneo 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.
- Background: PubMed 20567946Cameron 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.
- Background: PubMed 25932911Motl 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SEMRA OGUZ, PhD study chair
Marmara University
SEDA KARACA, MsC principal investigator
Marmara University
ELIF UNAL, Dr principal investigator
Okmeydanı Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SEDA KARACA (05077743857, aisa.sed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tampa Kinesiophobia Scale (TSK) (time frame: 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04183751, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.