Functional Status After CABG SurgeryNCT04425525
The Functional Difficulties Questionnaire-shortened Version: Turkish Translation, Validity and Reliability Study.
An observational study of Functional Status After CABG Surgery and Outcome Measure, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
The Functional Difficulties Questionnaire-shortened version "(FDQ-s) is a unique questionnaire that aimed at evaluating the functional performance of the upper extremities and trunk following cardiothoracic surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Functional Status After CABG Surgery, Outcome Measure
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 18 Jun 2020
- How long will I take part?
- 15 Days
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Having undergone coronary artery bypass surgery with median sternotomi
Who may be able to join
- Being over the age of 18
- Having undergone coronary artery bypass surgery (via median sternotomi)
Who cannot join
- Not having ability to read and write in Turkish
- Having cognitive impairment
- Being in the intensive care unit for more than five days due to medical reasons.
- Having undergone surgery involving thorax or upper extremity in the last 6 months.
- Having neurologic or musculoskeletal problems to prevent evaluation, ambulation and exercise.
- Patients who have an infection or unhealed scar after surgery even if their first measurements are made
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation of The Functional Difficulties Questionnaire-shortened Version Survey to Turkish and Determination of Psychometric Properties: Validity and Reliability Study.
The Functional Difficulties Questionnaire-shortened version "(FDQ-s) is a unique questionnaire that aimed at evaluating the functional performance of the upper extremities and trunk following cardiothoracic surgery.
Aim of this study is adaptation of the FDQ-s questionnaire to Turkish culture and study its psychometric properties, validity and reliability.
Read the detailed description
Cardiac surgeries performed by sternotomy method are the most common surgical treatment method in coronary artery disease. Although the median sternotomy has advantages in terms of ease of application, cost and long-term survival, muskuloskeletal complications can be encountered in the postoperative period.
In the studies conducted, it was found that patients had difficulties in functional activities including mobilization and daily life activities after median sternotomy. Also restrictions or loss of motion can be observed in the joint range of motion of the shoulder joint and thoracic region.
The FDQ-s scale consists of 10 functional tasks developed by Sturgess et al. These tasks are activities such as coughing, sneezing, deep breathing, movements involving the upper extremity, turning in bed, sitting upright in the chair, and ambulation. When applying FDQ-s, patients will mark how hard they are in each task on the 100 mm straight line. The first point on the left means "no difficulty" and the last point on the right means "maximum difficulty". The score will be determined by measuring from the starting point to the place marked by the patient. The total score is at most 100 points and at least 0 points. The high score indicates that the patient's difficulty level is high.
Although there are many functional difficulties faced by patients in the postoperative period, there is no outcome measurement in our language that evaluates the level of these difficulties globally and objectively.
Our research will be done due to the elimination of this deficiency in the literature.
- Keywords
- heart surgery, function, measure, validity, reliability.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Functional Status (with FDQ-s: Turkish version questionnaire)
FDQ-S is a questionnaire created to evaluate the difficulties faced by patients undergoing cardiac surgery, especially when performing functional tasks of the thoracic region and upper extremity. The questionnaire consisting of 10 questions in total, the patients marked how much difficulty they had in each task, on a 100 mm straight line.The first point on the left means "no difficulty" and the last point on the right means "maximum difficulty". The score was determined by measuring from the starting point to the place marked by the patient. The total score is at most 100 points and at least 0 points. The high score indicates that the patient's strain level is high. With time frames we aimed to evaluate the change of the difficulty of patients function.
Measured: First day at the hospital (pre-op), day of discharge (post-op), 15th day after discharge (control).
Secondary outcomes (4)
Change of the Mobility Status : (Barthel İndex of Activities of Daily Living)
Barthel Index determines the level of addiction of the patient in 10 sections: nutrition, washing, self-care, dressing and bowel care, bladder care, toilet care, wheelchair to bed and vice versa, mobility (walking on a smooth surface, using the wheelchair: if appropriate), going up and down stairs.The total score is in the range of 0-100, which means 0-20 points: fully dependent, 21-61: highly dependent, 62-90: moderately dependent, 91-99: slightly dependent, 100 points: fully independent.With time frames we aimed to evaluate the change of the mobility scores.
Measured: Day of discharge (post-op), 15th day after surgery (control day).
Change of the Quality of Life Status: (SF-36 Quality of Life Questionnaire)
SF-36 is the most common scale used to measure individuals' quality of life. This scale examines 8 dimensions of health with 36 items such as physical function, role restrictions (due to physical and emotional problems), social function, mental health, vitality (energy), pain and general perception of health.Instead of giving only one total score, the scale gives total score separately for each subscale.100 points indicate good health, 0 points indicate bad health. With time frame we aimed to evaluate the cange of the life quality score of patients.
Measured: Day of discharge (post-op), 15th day after surgery (control day).
Change of the Pain Status: (Visual Analogue Scale)
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The distance from the 0 point to the place marked by the patient indicates the pain of the patient. With time frame we aimed to evaluate the change of the life quality score of patients.
Measured: First day at the hospital (pre-op), day of discharge (post-op), 15th day after surgery (control day).
Change of the Mobility Status: (Perme Intensive Care Mobility Score)
The Perme ICU Mobility Score is a tool developed to measure the patient's mobility status starting with the ability to follow commands and culminating in the distance walked in two minutes. A total score of 3 or 4 is given for each item, reflecting the patient's mobility. A high score indicates a small amount of mobility barrier and low help, while a low score indicates more mobility and more help needed for mobility. With time frame we aimed to evaluate the change of the mobility score.
Measured: Day of discharge (post-op), 15th day after surgery (control day).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Nov 2018
- Primary completion15 May 2020
- Study completion18 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Status After CABG 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 70 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Collaborators
- Aydın Private Medinova Hospital
- Responsible party
- Principal investigator, Ayşe Adıgüzel Bayar, Muğla Sıtkı Koçman University
- Investigators
- Ayşe Adıgüzel Bayar, MSc Student, Principal investigator, Muğla Sıtkı Koçman University/ Private Medinova HospitalBaki Umut Tuğay, Prof. Dr., Study director, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425525
- Sponsor's protocol ID
- MSc Thesis
- Status last verified
- Sep 2026
- First submitted
- 4 Jun 2020
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of The Functional Difficulties Questionnaire-shortened Version Survey to Turkish and Determination of Psychometric Properties: Validity and Reliability Study.
- ClinicalTrials.gov ID
- NCT04425525
- Acronym / sponsor ID
- MSc Thesis
- Keywords
- heart surgery, function, measure, validity, reliability.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Collaborators
- Aydın Private Medinova Hospital
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 18 Jun 2020 (actual)
- First posted
- 11 Jun 2020 (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 Functional Difficulties Questionnaire-shortened version "(FDQ-s) is a unique questionnaire that aimed at evaluating the functional performance of the upper extremities and trunk following cardiothoracic surgery.
Aim of this study is adaptation of the FDQ-s questionnaire to Turkish culture and study its psychometric properties, validity and reliability.
Detailed description
Cardiac surgeries performed by sternotomy method are the most common surgical treatment method in coronary artery disease. Although the median sternotomy has advantages in terms of ease of application, cost and long-term survival, muskuloskeletal complications can be encountered in the postoperative period.
In the studies conducted, it was found that patients had difficulties in functional activities including mobilization and daily life activities after median sternotomy. Also restrictions or loss of motion can be observed in the joint range of motion of the shoulder joint and thoracic region.
The FDQ-s scale consists of 10 functional tasks developed by Sturgess et al. These tasks are activities such as coughing, sneezing, deep breathing, movements involving the upper extremity, turning in bed, sitting upright in the chair, and ambulation. When applying FDQ-s, patients will mark how hard they are in each task on the 100 mm straight line. The first point on the left means "no difficulty" and the last point on the right means "maximum difficulty". The score will be determined by measuring from the starting point to the place marked by the patient. The total score is at most 100 points and at least 0 points. The high score indicates that the patient's difficulty level is high.
Although there are many functional difficulties faced by patients in the postoperative period, there is no outcome measurement in our language that evaluates the level of these difficulties globally and objectively.
Our research will be done due to the elimination of this deficiency in the literature.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 15 Days
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Having undergone coronary artery bypass surgery with median sternotomi
Key inclusion criteria (2 listed)
- Being over the age of 18
- Having undergone coronary artery bypass surgery (via median sternotomi)
Key exclusion criteria (6 listed)
- Not having ability to read and write in Turkish
- Having cognitive impairment
- Being in the intensive care unit for more than five days due to medical reasons.
- Having undergone surgery involving thorax or upper extremity in the last 6 months.
- Having neurologic or musculoskeletal problems to prevent evaluation, ambulation and exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of the Functional Status (with FDQ-s: Turkish version questionnaire)
Time frame: First day at the hospital (pre-op), day of discharge (post-op), 15th day after discharge (control).
FDQ-S is a questionnaire created to evaluate the difficulties faced by patients undergoing cardiac surgery, especially when performing functional tasks of the thoracic region and upper extremity. The questionnaire consisting of 10 questions in total, the patients marked how much difficulty they had in each task, on a 100 mm straight line.The first point on the left means "no difficulty" and the last point on the right means "maximum difficulty". The score was determined by measuring from the starting point to the place marked by the patient. The total score is at most 100 points and at least 0 points. The high score indicates that the patient's strain level is high. With time frames we aimed to evaluate the change of the difficulty of patients function.
4 secondary outcomes
Change of the Mobility Status : (Barthel İndex of Activities of Daily Living)
Time frame: Day of discharge (post-op), 15th day after surgery (control day).
Change of the Quality of Life Status: (SF-36 Quality of Life Questionnaire)
Time frame: Day of discharge (post-op), 15th day after surgery (control day).
Change of the Pain Status: (Visual Analogue Scale)
Time frame: First day at the hospital (pre-op), day of discharge (post-op), 15th day after surgery (control day).
Change of the Mobility Status: (Perme Intensive Care Mobility Score)
Time frame: Day of discharge (post-op), 15th day after surgery (control day).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
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.
Ayşe Adıgüzel Bayar, MSc Student principal investigator
Muğla Sıtkı Koçman University/ Private Medinova Hospital
Baki Umut Tuğay, Prof. Dr. study director
Muğla Sıtkı Koçman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Status After CABG Surgery and Outcome Measure, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 24 Sep 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the Functional Status (with FDQ-s: Turkish version questionnaire) (time frame: First day at the hospital (pre-op), day of discharge (post-op), 15th day after discharge (control).). 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 24 Sep 2026.