- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05429307
Turkish Adaptation, Validity and Reliability of Exercise Sensitivity Questionnaire
February 28, 2023 updated by: Reyhan Kaygusuz
Interoceptive complex sensations and fear beliefs resulting from cardiac risk factors or cardiovascular disease can further increase one's awareness and attention to bodily situations and cause differences in the interpretation of somatic sensations.
These intraceptive somatic sensations may be the underlying factors for participation in exercise and compliance with exercise programs No Turkish questionnaire evaluating unpleasant sensations (Exercise sensitivity) was found.
Exercise Sensitivity Questionnaire, which we planned to validate in our study, is a questionnaire developed by Samantha Farris et al. in 2020 to measure anxiety, exercise avoidance behavior and exercise sensitivity, which are frequently observed in individuals with heart disease.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The reliability and validity of the scale will begin with language equivalence and cultural adaptation.
The scale will be translated from English to Turkish by two people who are fluent in Turkish and English.
A single Turkish translation will be obtained from these two Turkish translations with a common opinion.
The scale, which has been translated into Turkish, will be translated into English by two other people who are fluent in Turkish and English.
The scale translated into English will be compared with the original.
If the developer of the scale, miguel blacutt and Stults-Kolehmainen approves the translation of the scale, participants will be recruited for the study.
In the pre-trial phase, a pre- assessment will be conducted with 15 participants to test the intelligibility of the scale.
Based on the results of the pre-test phase, the final version of Exercise Sensitivity Questionnaire will be able to be modified.
Exercise Sensitivity Questionnaire scale questions and questions in the data collection form face to face 450 participants will be included in the study.
In order to evaluate the validity of the Exercise Sensitivity Questionnaire.Tampa Kinesiophobia- Heart and Tampa Kinesiophobia has been validated in Turkish, will be used.
Scales will be repeated after 15 days to assess test-retest reliability.
Study Type
Observational
Enrollment (Actual)
450
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey
- Istanbul Demiroglu University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
-Population over 35 years of age with self-reported heart disease (heart failure, acute myocardial infarction, coronary artery disease, coronary bypass surgery, heart valve surgery, history of stable angina, pacemaker) voluntarily to participate in the study
Description
Inclusion Criteria:
- Being older than 35 years,
- Having a self-reported heart disease (heart failure, acute myocardial infarction, coronary artery disease, coronary by-pass surgery, heart valve surgery, history of stable angina, cardiac have battery)
- To have agreed to participate in the study,
- have internet access,
- Being a mother tongue Turkish.
- Carrying at least two of the cardiac risk factors (hypertension, Type 2 diabetes, hyperlipidemia/dyslipidemia, overweight or obesity (BMI>25), physical inactivity (less than 150 minutes of moderate-intensity exercise per week, smoking)
Exclusion Criteria:
- Not answering all questions
- Cognitive defect or cooperation disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise sensitivity
Time Frame: Beseline
|
It is a scale developed by Samantha Farris et al. in 2020 to measure anxiety, exercise avoidance behavior and exercise sensitivity, which are frequently observed in individuals with heart disease.
The survey is included in Annex-2.
The scale consists of 18 questions in total, consisting of "Not at all", "Very little", "A little", "Too much" and "Too much", and a 5-point Likert type scored between 0-4.
Scale scoring is calculated in two subcategories (cardiopulmonary category and pain/weakness category).
Scores of questions 6, 8, 11, 12, 13, 14, 15, 15, 16, 17 for the cardiopulmonary category summed and divided by the number of questions.
For the pain/weakness category, the scores of questions 1, 2, 3, 4, 5, 6, 7, 9, 10, 18 are added and divided by the number of questions.
Higher scores indicate higher sensitivity
|
Beseline
|
Kinesiophobia for Heart Disease
Time Frame: Beseline
|
The concept of kinesiophobia was first introduced by Kori et al.
Kinesiophobia is also known as fear of movement, avoidance.
(Kori et al., 1990).
The TAMPA kinesiophobia scale was developed by Vlaeyen et al. (Vlaeyen et al, 2000) to assess the kinesiophobia of patients with low back pain.
Bäck et al., on the other hand, rearranged the TAMPA kinesiophobia scale for heart patients and developed the TAMPA Kinesiophobia Rating Scale for the Heart (Bäck et al, 2012).
CTSS evaluates the subjective assessment of kinesiophobia in relation to cardiac conditions.
The scale consists of four subgroups, which include exercise avoidance, fear of injury, perceived danger for heart problems, and dysfunction.
"Strongly disagree" (score It consists of a total of 17 questions on a 4-point Likert scale, scored between 1) and "strongly agree" (score 4).
|
Beseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Actual)
December 15, 2022
Study Completion (Actual)
December 26, 2022
Study Registration Dates
First Submitted
June 18, 2022
First Submitted That Met QC Criteria
June 18, 2022
First Posted (Actual)
June 23, 2022
Study Record Updates
Last Update Posted (Actual)
March 2, 2023
Last Update Submitted That Met QC Criteria
February 28, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESQ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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