NCT06432153

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

June 16, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

12 months

First QC Date

May 22, 2024

Last Update Submit

May 22, 2024

Conditions

Keywords

Cardiovascular diseaseKinesiophobiaScale reliability and validity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • International Physical Activity Questionnaire

    baseline and at the end of the third month

  • 6-Minute Walk Test

    baseline and at the end of the third month

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

    baseline and at the end of the third month

  • Hospital Anxiety and Depression Scale (HADS)

    baseline and at the end of the third month

Study Arms (1)

participant

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

Other: observation

Interventions

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

participant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

clinical patients diagnosed with cardiovascular diseases.

You may qualify if:

  • (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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

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

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesKinesiophobia

Interventions

Observation

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Ai-Ling Chang, MSc

    Changhua Christian Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ai-Ling Chang, MSc

CONTACT

Wan-Ting Huang, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2024

First Posted

May 29, 2024

Study Start

June 16, 2024

Primary Completion

June 15, 2025

Study Completion

July 31, 2025

Last Updated

May 29, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

No plans to share related information.