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

NCT ID: NCT06625892

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-14

Study Completion Date

2026-07-31

Brief Summary

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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

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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.

Conditions

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Cardiac Diseases Requiring Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
The outcome assessors dose not know the allocation of groups.

Study Groups

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the interventions group

The experimental group undergoes a 12-week multidimensional interventions.

Group Type EXPERIMENTAL

the multidimensional interventions

Intervention Type 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 control group

the control group receives no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Da-Yeh University

OTHER

Sponsor Role collaborator

Ai-Ling Chang

OTHER

Sponsor Role lead

Responsible Party

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Ai-Ling Chang

Supervisor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wan-Ting Huang, PhD

Role: PRINCIPAL_INVESTIGATOR

Da-Yeh University

Locations

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Changhua Christian Hospital

Changhua, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chang Ai-Ling, Master

Role: CONTACT

886-917160905

Wan-Ting Huang, PhD

Role: CONTACT

886-953860172

Facility Contacts

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Ai-Ling Chang, Master

Role: primary

886-917160905

Wan-Ting Huang, PhD

Role: backup

+886-953860172

Other Identifiers

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231124

Identifier Type: -

Identifier Source: org_study_id

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