Heart DiseasesNCT05429307
Turkish Adaptation, Validity and Reliability of Exercise Sensitivity Questionnaire
An observational study of Heart Diseases and Exercise Addiction, run by Reyhan Kaygusuz at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Heart Diseases, Exercise Addiction, Sensitivity
- What is being tested?
- Population
- How many people
- 450 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 26 Dec 2022
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- Not answering all questions
- Cognitive defect or cooperation disorder
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Heart Diseases, Exercise Addiction, Sensitivity
- Being tested
- Population
- Medical subject headings
- Heart Diseases, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PopulationOther
Turkish Validity and Reliability of The Exercise Sensitivity Questionnair Scale to Turkish society and to make its validity and reliability in Turkish.
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise sensitivity
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
Measured: Beseline
Kinesiophobia for Heart Disease
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).
Measured: Beseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start1 May 2022
- Primary completion15 Dec 2022
- Study completion26 Dec 2022
Why it stopped: clinical eligibility for patient recruitment not achieved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- 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
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reyhan Kaygusuz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reyhan Kaygusuz, Istanbul Demiroglu Bilim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429307
- Sponsor's protocol ID
- ESQ
- Status last verified
- Feb 2023
- First submitted
- 18 Jun 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Adaptation, Validity and Reliability of Exercise Sensitivity Questionnaire
- ClinicalTrials.gov ID
- NCT05429307
- Acronym / sponsor ID
- ESQ
- Conditions
- Heart Diseases, Exercise Addiction, Sensitivity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: clinical eligibility for patient recruitment not achieved
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Reyhan KaygusuzUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 26 Dec 2022 (actual)
- First posted
- 23 Jun 2022 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Not answering all questions
- Cognitive defect or cooperation disorder
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 |
|---|---|---|
| PopulationTurkish Validity and Reliability of The Exercise Sensitivity Questionnair Scale to Turkish society and to make its validity and reliability in Turkish. | Other | – |
Primary outcome
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
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).
Results and safety
The study was stopped early (reason given: clinical eligibility for patient recruitment not achieved). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Heart Diseases and Exercise Addiction, run by Reyhan Kaygusuz 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 6 inclusion and 2 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: stopped early, as of the sponsor's last update on 2 Mar 2023. 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?
The study was stopped early (reason given: clinical eligibility for patient recruitment not achieved). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise sensitivity (time frame: Beseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2023.