Tampa Scale of Kinesiophobia for Heart Taiwan Version Validation

Cardiovascular Diseases Clinical Trial

Official title:

Tampa Scale of Kinesiophobia for Heart Taiwan Version Validation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06432153
• Other study ID #: N_112_0424
• Status: Not yet recruiting
• Start date: June 16, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: May 2024
• Source: Changhua Christian Hospital
• Contact: Ai-Ling Chang, MSc
• Phone: +886-048336558
• Email: 23570[@]cch.org.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: July 31, 2025
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Kinesiophobia

Intervention

Other:
• observation
Participants who receive routine clinical care, without additional intervention from the study

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Changhua Christian Hospital	Da-Yeh University

References & Publications (7)

ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Errat — View Citation

Back M, Jansson B, Cider A, Herlitz J, Lundberg M. Validation of a questionnaire to detect kinesiophobia (fear of movement) in patients with coronary artery disease. J Rehabil Med. 2012 Apr;44(4):363-9. doi: 10.2340/16501977-0942. — View Citation

Cakal B, Yildirim M, Emren SV. Kinesiophobia, physical performance, and health-related quality of life in patients with coronary artery disease. Postepy Kardiol Interwencyjnej. 2022 Sep;18(3):246-254. doi: 10.5114/aic.2022.122892. Epub 2022 Dec 17. — View Citation

Jones PS, Lee JW, Phillips LR, Zhang XE, Jaceldo KB. An adaptation of Brislin's translation model for cross-cultural research. Nurs Res. 2001 Sep-Oct;50(5):300-4. doi: 10.1097/00006199-200109000-00008. — View Citation

Keessen P, Kan KJ, Ter Riet G, Visser B, Jorstad H, Latour C, van Duijvenbode I, Scholte Op Reimer W. Impact of kinesiophobia on initiation of cardiac rehabilitation: a prospective cohort path analysis. BMJ Open. 2022 Nov 25;12(11):e066435. doi: 10.1136/b — View Citation

Liou YM, Jwo CJ, Yao KG, Chiang LC, Huang LH. Selection of appropriate Chinese terms to represent intensity and types of physical activity terms for use in the Taiwan version of IPAQ. J Nurs Res. 2008 Dec;16(4):252-63. doi: 10.1097/01.jnr.0000387313.20386 — View Citation

Lynn MR. Determination and quantification of content validity. Nurs Res. 1986 Nov-Dec;35(6):382-5. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tampa Scale of Kinesiophobia for Heart	This scale, developed by Bäck et al. (2012), assesses fear of movement in patients with coronary artery disease. It comprises four dimensions: exercise avoidance, fear of injury, dysfunctional self-perception, and perceived risk of heart problems, with 17 items. Each item is scored on a 4-point Likert scale (1 = strongly disagree to 4 = strongly agree), and items 4, 8, 12, and 16 are reverse scored. The total score ranges from 17 to 68, with higher scores indicating greater fear of movement. A TSK Heart score below 37 indicates a low fear of movement, while a score of 37 or higher indicates a high fear of movement. The scale's intra-class correlation coefficient is 0.83, and its internal consistency (Cronbach's alpha) is 0.78 (Bäck et al., 2012).	baseline and at the end of the third month
Secondary	International Physical Activity Questionnaire	This study uses the short form of the Taiwan version of the IPAQ, developed in collaboration with Liu Ying-Mei and the World Health Organization. It consists of 7 items assessing physical activity over the past week across work, household chores, transportation, and leisure activities, including time and frequency of walking, moderate and vigorous activities, and time spent sitting. The total physical activity is calculated by multiplying each activity category by its corresponding Metabolic Equivalent (MET), execution time, and activity days. An IPAQ score below 600 indicates low physical activity, 600-3000 indicates moderate physical activity, and above 3000 indicates high physical activity. The scale's content validity is 0.994, and its intra-class correlation coefficient is 0.704 (Liou et al., 2008).	baseline and at the end of the third month
Secondary	6-Minute Walk Test	This test is commonly used in clinical settings to assess an individual's exercise capacity and endurance by measuring the distance walked in six minutes. During the test, participants are asked to walk as far as possible along a 30-meter corridor in six minutes. They can rest if they experience difficulty breathing (ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories, 2002).	baseline and at the end of the third month
Secondary	Taiwan Brief Version of the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)	Professor Yao Kai-Ping developed this questionnaire after obtaining authorization; this questionnaire assesses the quality of life across four domains: physical health, psychological well-being, social relationships, and environment, with 28 items. Each item is scored on a 5-point scale. Scores for each domain are calculated by averaging the scores of the items within that domain and multiplying by 4. Items 3, 4, and 26 are reverse-scored by subtracting the original score from 6. Higher scores indicate a better quality of life. The internal consistency is 0.91, and the content validity of the domains ranges from 0.51 to 0.64 (Taiwan WHOQOL Group, 2000; Yao Kai-Ping, 2002).	baseline and at the end of the third month
Secondary	Hospital Anxiety and Depression Scale (HADS)	This study uses the Chinese version of the HADS, translated by Chen Mei-Ling, initially developed by Zigmond and Snaith (1983). The scale consists of 14 items scored on a 4-point Likert scale (0 to 3), with separate scores for anxiety and depression. Each subscale has a total score range of 0 to 21, with higher scores indicating greater levels of anxiety or depression.	baseline and at the end of the third month

External Links

•   WHOQOL BREF