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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey
      • Istanbul, Turkey
        • Istanbul Demiroglu University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Reyhan Kaygusuz

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 26, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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