Investigating the Related Factors and Outcome of Kinesiophobia and the Effects of Multidimensional Interventions in Cardiac Surgery Patients

The primary objective of this two-year research project is to investigate the status of activity fear, its related factors, and prognosis in cardiac surgery patients in the first year. Subsequently, the study aims to develop a comprehensive intervention strategy combining exercise with cognitive-behavioral approaches tailored for cardiac surgery patients and assess the effectiveness of this intervention on activity fear, prognosis, and quality of life in the second year.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Diseases Requiring Surgery
• Intervention / Treatment: Behavioral: the multidimensional interventions

Detailed Description

The study uses a convenient sampling method, focusing on patients undergoing cardiac surgery in the cardiac surgery ward of the Central Medical Center. The first-year research adopts a descriptive, correlational, and repeated-measures design, while the second-year research employs an experimental design. Participants are randomly assigned to either the experimental or control group. The experimental group undergoes a 12-week multidimensional interventions, while the control group receives no intervention. Data are collected through structured questionnaires. Data collection occurs at discharge, two weeks post-discharge, six weeks, 12 weeks, and 24 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 245
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chang Ai-Ling, Master; Phone Number: 886-917160905; Email: 23570@cch.org.tw
• Study Contact Backup: Name: Wan-Ting Huang, PhD; Phone Number: 886-953860172; Email: wanting@mail.dyu.edu.tw

Study Locations

• Taiwan
  • Changhua, Taiwan
    • Recruiting
    • Changhua Christian Hospital
    • Contact: Ai-Ling Chang, Master; Phone Number: 886-917160905; Email: 23570@cch.org.tw
    • Contact: Wan-Ting Huang, PhD; Phone Number: +886-953860172; Email: wanting@mail.dyu.edu.tw
    • Contact: Wan-Ting Huang, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients received cardiac surgery.
• Aged 18 or above.
• Clear consciousness and able to communicate in Mandarin or Taiwanese.
• Willing and consent to participate after being informed of the study purpose and procedures.

Exclusion Criteria:

• Cognitive impairment,
• Psychiatric disorders, and
• Long-term bedridden patients who rely on others for daily activities.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the interventions group; The experimental group undergoes a 12-week multidimensional interventions.	Behavioral: the multidimensional interventions; The study participants will receive cognitive behavior therapy intervention for six weeks, one session per week, 45 minutes each time, and exercise training for twelve weeks, twice sessions per week, 60 minutes each time.
No Intervention: the control group; the control group receives no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
kinesiophobia	Tampa Scale of Kinesiophobia for Heart (TSK Heart) was used for measuring kinesiophobia in this study. The TSK Heart 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).	1 day discharge, two weeks post-discharge, six weeks, 12 weeks, and 24 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Physical Activity Questionnaire (IPAQ)	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).	1 day discharge, two weeks post-discharge, six weeks, 12 weeks, and 24 weeks.
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).	1 day discharge, two weeks post-discharge, six weeks, 12 weeks, and 24 weeks.

Collaborators and Investigators

• Sponsor: Ai-Ling Chang
• Collaborators: Da-Yeh University
• Investigators: Principal Investigator: Wan-Ting Huang, PhD, Da-Yeh University

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: October 2, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: kinesiophobia, cardiac surgery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Mental Disorders; Phobic Disorders; Anxiety Disorders; Kinesiophobia; Heart Diseases
• Other Study ID Numbers: 231124

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No