Clinical trial NCT06432153: Tampa Scale of Kinesiophobia for Heart Taiwan Version Validation
Official title: Tampa Scale of Kinesiophobia for Heart Taiwan Version Validation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiovascular Diseases
Keywords: Cardiovascular disease
Kinesiophobia
Scale reliability and validity
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
Collaborators: name: Da-Yeh University
First posted: 2024-05-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: clinical patients diagnosed with cardiovascular diseases.

Brief summary: Early assessment of kinesiophobia in cardiovascular disease patients is essential. However, measurement tools are scarce for assessing activity fear in cardiovascular disease patients domestically. Currently, the Tampa Scale of Kinesiophobia for the Heart, developed by Bäck et al. (2012), is the most commonly used scale for measuring kinesiophobia among cardiovascular disease patients. As there is no tool available domestically to measure kinesiophobia in cardiovascular disease patients, this research aims to translate, revise, and establish the Taiwanese version of the Tampa Scale of Kinesiophobia for Heart and subsequently verify its reliability and validity for clinical assessment of kinesiophobia among cardiovascular disease patients.

The methodology involves following the translation model by Jones et al. (2001) to translate the Tampa Scale of Kinesiophobia for Heart from the English version to the Taiwan version. Structured questionnaires, including demographic and disease-related information, the Tampa Scale of Kinesiophobia for Heart Taiwan Version, the International Physical Activity Questionnaire, the Six-Minute Walk Test, the Taiwan version of the World Health Organization Quality of Life Questionnaire-BREF, the Hospital Anxiety and Depression Scale, and the Pain Catastrophizing Scale will be used at the cardiological outpatient clinic and inpatient ward of a medical center in Central Taiwan. Patients meeting the study's inclusion criteria and consent to participate in this study will be interviewed. Tampa Scale of Kinesiophobia for Heart Taiwan Version will be examined for content validity, construct validity, internal consistency, and test-retest reliability.

Detailed description: Cardiovascular disease patients may avoid physical activity or exercise due to concerns that engaging in physical activities might exacerbate their heart condition or lead to injury. Interpretation of potential injury as a threat can induce kinesiophobia (fear of movement), causing patients to avoid physical activities, which could negatively impact both their physiological and psychological well-being. Previous research indicates a high prevalence of kinesiophobia among cardiovascular disease patients, and this fear negatively affects their physical activity performance, unwillingness to engage in cardiac rehabilitation, and worse quality of life. Therefore, early assessment of kinesiophobia in cardiovascular disease patients is essential. However, measurement tools are scarce for assessing activity fear in cardiovascular disease patients domestically. Currently, the Tampa Scale of Kinesiophobia for the Heart, developed by Bäck et al. (2012), is the most commonly used scale for measuring kinesiophobia among cardiovascular disease patients. As there is no tool available domestically to measure kinesiophobia in cardiovascular disease patients, this research aims to translate, revise, and establish the Taiwanese version of the Tampa Scale of Kinesiophobia for Heart and subsequently verify its reliability and validity for clinical assessment of kinesiophobia among cardiovascular disease patients.

The objective of this study is to translate, revise, and establish the Taiwanese version of the Tampa Scale of Kinesiophobia for Heart and conduct reliability and validity verification.

The methodology involves following the translation model by Jones et al. (2001) to translate the Tampa Scale of Kinesiophobia for Heart from the English version to the Taiwan version. A longitudinal study design will verify the validity and reliability of the Taiwan version of the Tampa Scale of Kinesiophobia for Heart. Structured questionnaires, including demographic and disease-related information, the Tampa Scale of Kinesiophobia for Heart Taiwan Version, the International Physical Activity Questionnaire, the Six-Minute Walk Test, the Taiwan version of the World Health Organization Quality of Life Questionnaire-BREF, the Hospital Anxiety and Depression Scale, and the Pain Catastrophizing Scale will be used at the cardiological outpatient clinic and inpatient ward of a medical center in Central Taiwan. Patients meeting the study's inclusion criteria and consent to participate in this study will be interviewed. Tampa Scale of Kinesiophobia for Heart Taiwan Version will be examined for content validity, construct validity, internal consistency, and test-retest reliability. The collected data will be analyzed using SPSS/PC version 22.0, and statistical methods such as frequency, percentage, mean, standard deviation, reliability analysis, Pearson correlation, and exploratory factor analysis will be used.

This study aims to translate, revise, and establish the Taiwanese version of the Tampa Scale of Kinesiophobia for Heart and verify its reliability and validity for clinical assessment of Kinesiophobia among cardiovascular disease patients. It also aims to provide insight for future clinical research to analyze related factors further and develop intervention strategies, ultimately enhancing physical activity performance and quality of life and engaging in cardiac rehabilitation for cardiovascular disease patients.

Eligibility criteria: Inclusion Criteria:

* (1) diagnosed with cardiovascular diseases by a specialist, including coronary artery disease, arrhythmia, valvular heart disease, and heart failure, with stable conditions;
* (2) aged 18 or above;
* (3) clear consciousness and able to communicate in Mandarin or Taiwanese;
* (4) willing and consent to participate after being informed of the study purpose and procedures.

Exclusion Criteria:

* (1) cognitive impairment
* (2) psychiatric disorders
* (3) long-term bedridden patients who rely on others for daily activities.

Primary outcomes:
measure: Tampa Scale of Kinesiophobia for Heart
timeFrame: baseline and at the end of the third month
Secondary outcomes:
measure: International Physical Activity Questionnaire
timeFrame: baseline and at the end of the third month
measure: 6-Minute Walk Test
timeFrame: baseline and at the end of the third month
measure: Taiwan Brief Version of the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)
timeFrame: baseline and at the end of the third month
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline and at the end of the third month
Other outcomes:
Locations:
Study officials:
affiliation: Changhua Christian Hospital
name: Ai-Ling Chang, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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