NCT05429307

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2022

Completed
Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

8 months

First QC Date

June 18, 2022

Last Update Submit

February 28, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    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).

    Beseline

Interventions

Turkish Validity and Reliability of The Exercise Sensitivity Questionnair Scale to Turkish society and to make its validity and reliability in Turkish.

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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)

You may not qualify if:

  • Not answering all questions
  • Cognitive defect or cooperation disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Demiroglu University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart DiseasesHypersensitivity

Interventions

Population

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 18, 2022

First Posted

June 23, 2022

Study Start

May 1, 2022

Primary Completion

December 15, 2022

Study Completion

December 26, 2022

Last Updated

March 2, 2023

Record last verified: 2023-02

Locations