Cardiac Diseases Requiring SurgeryNCT06625892
Investigating the Related Factors and Outcome of Kinesiophobia and the Effects of Multidimensional Interventions in Cardiac Surgery Patients
A study testing the multidimensional interventions in people with Cardiac Diseases Requiring Surgery, run by Ai-Ling Chang at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiac Diseases Requiring Surgery
- What is being tested?
- the multidimensional interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Aug 2024to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Cognitive impairment,
- Psychiatric disorders, and
- Long-term bedridden patients who rely on others for daily activities.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Changhua Christian Hospital
Changhua
Ai-Ling Chang, Master, 886-917160905, 23570@cch.org.tw
Wan-Ting Huang, PhD, +886-953860172, wanting@mail.dyu.edu.tw
About this study
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.
Read the 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.
- Conditions
- Cardiac Diseases Requiring Surgery
- Being tested
- the multidimensional interventions
- Keywords
- kinesiophobia, cardiac surgery
- Medical subject headings
- Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the multidimensional interventionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| the interventions group | Experimental | The experimental group undergoes a 12-week multidimensional interventions. Receives: Behavioral: the multidimensional interventions |
| the control group | No intervention | the control group receives no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day discharge, two weeks post-discharge, six weeks, 12 weeks, and 24 weeks.
Secondary outcomes (2)
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).
Measured: 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).
Measured: 1 day discharge, two weeks post-discharge, six weeks, 12 weeks, and 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start14 Aug 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Diseases Requiring SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 245 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ai-Ling Chang
- Sponsor type
- University, hospital or other
- Collaborators
- Da-Yeh University
- Responsible party
- Sponsor-investigator, Ai-Ling Chang, Changhua Christian Hospital
- Investigators
- Wan-Ting Huang, PhD, Principal investigator, Da-Yeh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625892
- Sponsor's protocol ID
- 231124
- Status last verified
- Oct 2024
- First submitted
- 2 Oct 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Related Factors and Outcome of Kinesiophobia and the Effects of Multidimensional Interventions in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT06625892
- Acronym / sponsor ID
- 231124
- Conditions
- Cardiac Diseases Requiring Surgery
- Keywords
- kinesiophobia, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- Ai-Ling ChangUniversity, hospital or other
- Collaborators
- Da-Yeh University
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| the interventions group | Experimental | Behavioral: the multidimensional interventionsThe experimental group undergoes a 12-week multidimensional interventions. |
| the control group | No intervention | –the control group receives no intervention. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Cognitive impairment,
- Psychiatric disorders, and
- Long-term bedridden patients who rely on others for daily activities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the multidimensional interventionsThe 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. | Behavioural | the interventions group |
Primary outcome
kinesiophobia
Time frame: 1 day discharge, two weeks post-discharge, six weeks, 12 weeks, and 24 weeks.
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).
2 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wan-Ting Huang, PhD principal investigator
Da-Yeh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the multidimensional interventions in people with Cardiac Diseases Requiring Surgery, run by Ai-Ling Chang at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang Ai-Ling, Master (886-917160905, 23570@cch.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
kinesiophobia (time frame: 1 day discharge, two weeks post-discharge, six weeks, 12 weeks, and 24 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.