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The Effect of Kinesiophobia on Physical Activity, Balance and Falling in Parkinson's Disease Patients

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ClinicalTrials.gov Identifier: NCT03827746
Recruitment Status : Active, not recruiting
First Posted : February 1, 2019
Last Update Posted : September 5, 2019
Sponsor:
Collaborators:
Marmara University
Istanbul University-Cerrahpasa
Koç University
Information provided by (Responsible Party):
Gamze Ertürk, Istanbul Kültür University

Brief Summary:
The kinesiophobia; defined as irrational fear of movement, which may occur after painful injury and reduce physical activity. It develops the idea that movement in individuals will cause re-injury and cause additional pain to existing pain. Studies have shown that this situation leads to a decrease in physical fitness, avoidance of activity, decrease in quality of life and even depression in the long term. It is known that functional problems such as balance problems and decrease in physical activity level occur in patients with Parkinson's disease. However, in the literature, there is no study investigating the presence of kinesiophobia in patients with Parkinson's disease. Therefore, the aims of our study were to 1) determine the presence / absence of kinesiophobia in patients with Parkinson's disease 2) determine the relationship between kinesiophobia and falling, balance, physical activity level in the presence of kinesiophobia.

Condition or disease Intervention/treatment
Parkinson Disease Kinesiophobia Physical Activity Balance Falling Other: Tampa Kinesiophobia Scale, Berg-Balance Test, International Physical Activity Questionnaire-Short Form, Falls Efficacy Scale

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effect of Kinesiophobia on Physical Activity, Balance and Falling in Parkinson's Disease Patients
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : April 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Tampa Kinesiophobia Scale, Berg-Balance Test, International Physical Activity Questionnaire-Short Form, Falls Efficacy Scale

    Tampa Kinesiophobia Scale: The TSK is a 17-item self report checklist using a 4-point Likert scale that was developed as a measure of fear of movement or (re)injury.

    Berg-Balance Test: 14-item scale designed to measure balance of the older adult in a clinical setting.

    International Physical Activity Questionnaire-Short Form: This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting.

    Falls Efficacy Scale: A 16- item self-administered questionnaire designed to assess fear of falling in mainly older population



Primary Outcome Measures :
  1. Tampa Kinesiophobia Scale (TSK) [ Time Frame: 10 minutes ]
    It is a 17-item self report checklist using a 4-point Likert scale

  2. Berg-Balance Test [ Time Frame: 15-20 minutes ]
    14-item scale designed to measure balance of the older adult in a clinical setting. Scoring: A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 56 41-56 = low fall risk 21-40 = medium fall risk 0 -20 = high fall risk

  3. Falls Efficacy Scale [ Time Frame: 5-7 minutes ]
    It is a 10 item scale where each item is rated on a scale of 1-10. A score of 10 signifies no confidence in these activities; a score of 1 indicates confidence. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.

  4. International Physical Activity Questionnaire - Short form [ Time Frame: 5-10 minutes ]

    This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. Walking = 3.3 METs Moderate Intensity = 4.0 METs Vigorous Intensity = 8.0 METs Total MET-minutes/week = Walk (METs*min*days) + Mod (METs*min*days) + Vig (METs*min*days)

    1. Low: • No activity is reported OR • Some activity is reported but not enough to meet Categories 2 or 3. 2. Moderate: • 3 or more days of vigorous activity of at least 20 minutes per day OR • 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day OR • 5 or more days of any combination of walking, moderate-intensity or vigorousintensity activities achieving a minimum of at least 600 MET-minutes/week. 3. High: • Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week OR • 7 or more days of any combination of walki




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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The population of the study consisted of patients with Parkinson's disease who were in 1-3 stages according to Hoehn-Yahr Scale.

The sample consisted of 60 patients who applied to Istanbul University Cerrahpaşa Medical Faculty Neurology Department Movement Disorders Unit, complied with the inclusion criteria, read the information form and signed an informed consent form.

Criteria

Inclusion Criteria:

  • Being diagnosed with Parkinson's disease according to the criteria of United Kingdom Brain Bank and diagnosed as Parkinson's disease by neurologist
  • According to Hoehn-Yahr scale 1-3
  • Mini-Mental Test score 24 and above

Exclusion Criteria:

  • Another disease that will prevent walking
  • Visual impairment and vestibular dysfunction
  • Cognitive impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827746


Locations
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Turkey
Marmara University
Istanbul, Turkey
Sponsors and Collaborators
Istanbul Kültür University
Marmara University
Istanbul University-Cerrahpasa
Koç University

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Responsible Party: Gamze Ertürk, Research assistant, Istanbul Kültür University
ClinicalTrials.gov Identifier: NCT03827746     History of Changes
Other Study ID Numbers: 09.2017.226
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gamze Ertürk, Istanbul Kültür University:
Parkinson's Disease, Kinesiophobia, Physical Activity, Balance, Falling
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases