Menu
Recruiting NCT06625892

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

No phase Interventional Cardiac Diseases Requiring Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: the multidimensional interventions.
Who it may be relevant to
Registry conditions: Cardiac Diseases Requiring Surgery. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Primary outcome measures

  • kinesiophobia [Time frame: 1 day discharge, two weeks post-discharge, six weeks, 12 weeks, and 24 weeks.]
Secondary outcome measures (2)
  • International Physical Activity Questionnaire (IPAQ) [Time frame: 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) [Time frame: 1 day 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Taiwan · 1 center
  • Changhua Christian Hospital — Changhua

Identifiers

NCT: NCT06625892 · 231124

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗