Clinical trial NCT06625892: Investigating the Related Factors and Outcome of Kinesiophobia and the Effects of Multidimensional Interventions in Cardiac Surgery Patients
Official title: Investigating the Related Factors and Outcome of Kinesiophobia and the Effects of Multidimensional Interventions in Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Diseases Requiring Surgery
Keywords: kinesiophobia, cardiac surgery
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
Collaborators: name: Da-Yeh University
First posted: 2024-10-03
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: kinesiophobia
timeFrame: 1 day discharge, two weeks post-discharge, six weeks, 12 weeks, and 24 weeks.
Secondary outcomes:
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: 1 day discharge, two weeks post-discharge, six weeks, 12 weeks, and 24 weeks.
measure: Taiwan Brief Version of the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)
timeFrame: 1 day discharge, two weeks post-discharge, six weeks, 12 weeks, and 24 weeks.
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
Study officials:
affiliation: Da-Yeh University
name: Wan-Ting Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References: