## Protocol Section
### Identification Module
**NCT ID:** NCT06432153

**Brief Title:** Tampa Scale of Kinesiophobia for Heart Taiwan Version Validation

**Official Title:** Tampa Scale of Kinesiophobia for Heart Taiwan Version Validation

#### Organization Study ID Info
**ID:** N_112_0424
#### Organization
**Class:** OTHER
**Full Name:** Changhua Christian Hospital
### Status Module
#### Completion Date
**Date:** 2025-07-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-16

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Da-Yeh University

#### Lead Sponsor

**Class:** OTHER

**Name:** Changhua Christian Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Cardiovascular Diseases

**Keywords:**

- Cardiovascular disease

- Kinesiophobia

- Scale reliability and validity

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 400

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The only group of participant. Participants are outpatient clinical patients diagnosed with cardiovascular disease.

**Intervention Names:**

- Other: observation

**Label:** participant

### Interventions

#### Intervention 1

**Arm Group Labels:**

- participant

**Description:** Participants who receive routine clinical care, without additional intervention from the study

**Name:** observation

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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).

**Measure:** Tampa Scale of Kinesiophobia for Heart

**Time Frame:** baseline and at the end of the third month

#### Secondary Outcomes

**Description:** 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).

**Measure:** International Physical Activity Questionnaire

**Time Frame:** baseline and at the end of the third month

**Description:** 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).

**Measure:** 6-Minute Walk Test

**Time Frame:** baseline and at the end of the third month

**Description:** 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).

**Measure:** Taiwan Brief Version of the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)

**Time Frame:** baseline and at the end of the third month

**Description:** 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.

**Measure:** Hospital Anxiety and Depression Scale (HADS)

**Time Frame:** baseline and at the end of the third month

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** clinical patients diagnosed with cardiovascular diseases.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** 23570@cch.org.tw

**Name:** Ai-Ling Chang, MSc

**Phone:** +886-048336558

**Role:** CONTACT

**Contact 2:**

**Email:** wanting@mail.dyu.edu.tw

**Name:** Wan-Ting Huang, PhD

**Phone:** +886-0953860172

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Changhua Christian Hospital

**Name:** Ai-Ling Chang, MSc

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** No plans to share related information.

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.

**PMID:** 12091180

**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.

**PMID:** 22366980

**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.

**PMID:** 36751297

**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/bmjopen-2022-066435.

**PMID:** 36428018

**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.

**PMID:** 11570715

**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.0000387313.20386.0a.

**PMID:** 19061172

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

**PMID:** 3640358

#### See Also Links

**Label:** WHOQOL BREF

**URL:** https://www.semanticscholar.org/paper/Development-and-verification-of-validity-and-of-the-Yao-Chung/260271b00a65ac23b1324e52ef1597c13559f95d

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010698

- Term: Phobic Disorders

- ID: D000001008

- Term: Anxiety Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M2922

- Name: Kinesiophobia

- Relevance: HIGH

- As Found: Kinesiophobia

- ID: M13603

- Name: Phobic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000092442

- Term: Kinesiophobia

### Misc Info Module

- Version Holder: 2024-05-31
