NCT04425525

Brief 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. Aim of this study is adaptation of the FDQ-s questionnaire to Turkish culture and study its psychometric properties, validity and reliability.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2020

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

1.5 years

First QC Date

June 4, 2020

Last Update Submit

June 6, 2020

Conditions

Keywords

heart surgery, function, measure, validity, reliability.

Outcome Measures

Primary Outcomes (1)

  • 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.

    First day at the hospital (pre-op), day of discharge (post-op), 15th day after surgery (control).

Secondary Outcomes (4)

  • Change of the Mobility Status : (Barthel İndex of Activities of Daily Living)

    Day of discharge (post-op), 15th day after surgery (control day).

  • Change of the Quality of Life Status: (SF-36 Quality of Life Questionnaire)

    Day of discharge (post-op), 15th day after surgery (control day).

  • Change of the Pain Status: (Visual Analogue Scale)

    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)

    Day of discharge (post-op), 15th day after surgery (control day).

Other Outcomes (3)

  • Age

    First day at the hospital (pre-op)

  • Height

    First day at the hospital (pre-op)

  • BMI

    First day at the hospital

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Having undergone coronary artery bypass surgery with median sternotomi

You may qualify if:

  • Being over the age of 18
  • Having undergone coronary artery bypass surgery (via median sternotomi)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private Medinova Hospital

Aydin, Turkey (Türkiye)

Location

Study Officials

  • Ayşe Adıgüzel Bayar, MSc Student

    Muğla Sıtkı Koçman University/ Private Medinova Hospital

    PRINCIPAL INVESTIGATOR
  • Baki Umut Tuğay, Prof. Dr.

    Muğla Sıtkı Koçman University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
15 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

June 4, 2020

First Posted

June 11, 2020

Study Start

November 1, 2018

Primary Completion

May 15, 2020

Study Completion

June 18, 2020

Last Updated

June 11, 2020

Record last verified: 2020-06

Locations