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

NCT06625892 | Recruiting

• 1 other identifier: 231124
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Diseases Requiring Surgery

Keywords

kinesiophobia, cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• International Physical Activity Questionnaire (IPAQ)

  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)

  1 day discharge, two weeks post-discharge, six weeks, 12 weeks, and 24 weeks.

Study Arms (2)

the interventions group

EXPERIMENTAL

The experimental group undergoes a 12-week multidimensional interventions.

Behavioral: the multidimensional interventions

the control group

NO INTERVENTION

the control group receives no intervention.

Interventions

the multidimensional interventions BEHAVIORAL

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.

the interventions group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ai-Ling Chang: lead
• Da-Yeh University: collaborator

Study Sites (1)

Changhua Christian Hospital

Changhua, Taiwan

RECRUITING

MeSH Terms

Conditions

Kinesiophobia

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Wan-Ting Huang, PhD

  Da-Yeh University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chang Ai-Ling, Master

CONTACT

886-917160905; 23570@cch.org.tw

Wan-Ting Huang, PhD

CONTACT

886-953860172; wanting@mail.dyu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessors dose not know the allocation of groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Supervisor

Model Details: 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 comprehensive intervention, while the control group receives no intervention.

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 3, 2024
• Study Start: August 14, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 14, 2025

Record last verified: 2024-10

Locations

TW (1)