Clinical trial NCT05023083: Cross Cultural Adaptation of Functional Status Questionnaire in Urdu Language in CABG Patients
Official title: Cross Cultural Adaptation of Functional Status Questionnaire (FSQ) in Urdu Language in CABG Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CABG
Post-cardiac Surgery
Keywords: ADLs
CABG
Functional Status Questionnaire
FSQ
Quality of life.
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 healthy and 50 post CABG patients are included in the study

Brief summary: Aim of the study is to create an Urdu version of FSQ which will be of great importance for further research in field of cardiopulmonary physiotherapy, specially to make comparison across the population. We therefor aimed to develop a linguistically validated and reliable Urdu version of FSQ.

Detailed description: The Functional Status Questionnaire (FSQ) is a self-administered functional assessment that provides information on the patient's physical, psychological, social and role functions. The Functional Status Questionnaire is easier and more feasible to complete in short duration of time than the long forms. The FSQ was originally developed in English. It has been translated and validated in several languages and showed excellent reliability and responsiveness. The FSQ questionnaire is translated in Urdu to assess general health, ADLs and functional status of Post Coronary artery bypass graft surgery(CABG) patients. Translation will be performed by two independent translators going through all the steps following the guidelines. The two synthesized translations and the two back translations will be merged into one pre- final version of Urdu FSQ. The expert panel will then compare the conceptual equivalence, experiential equivalence, linguistic equivalence and metric equivalence. After this the final version of Urdu FSQ will be evaluated for validity in 50 Post CABG patients after getting their informed consent to participate in the study and their demographic characteristics. Inclusion criteria involves male and female patients of age between 40 to 60 years (ambulatory). Exclusion criteria includes patients with disability that prevent independent walking, acute cardiac condition, neurological conditions, cognitive impaired problem etc. Reliability and validity of FSQ Urdu version will be evaluated. It has been translated and validated in several languages and showed excellent reliability and responsiveness. However up to-date there is no validated Urdu version of the FSQ available. So, it is essential to translate FSQ in Urdu language to make it more comprehensive for local population who doesn't have command on English language. The purpose of this study is cross-cultural translation of the FSQ into Urdu language and to validate it into Urdu speaking population.

Hence, this study is aimed to produce the Urdu version for Urdu speaking countries, it will have a great significance for the physiotherapists, researchers and educators to assess CABG patients general health, QoL, functional status and ADLs where time is short because FSQ makes it easier to collect data from large populations in comparatively lesser time than long assessment forms.

Eligibility criteria: Inclusion Criteria:

* Able to read Urdu language
* Participating in community
* Patient is in ambulatory condition
* Post coronary artery bypass graft (CABG) Patients

Exclusion Criteria:

* Acute Cardiac event (e.g. myocardial infarction (MI), arrhythmia, angina) or intervention (e.g. percutaneous coronary intervention (PCI, valve repair, pacemaker fitting)
* Any other disability or neurological condition Cognitive issue Unwilling to participate

Primary outcomes:
measure: Translation of Functional Status Questionnaire(FSQ)
timeFrame: 6 months
measure: Validity of Translated Tool
timeFrame: 6 months
measure: Reliability of Translated Tool
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Functional Status Questionnaire (FSQ)
timeFrame: 15 min
Locations:
city: Lahore
country: Pakistan
facility: Mayo hospital Lahore
state: Asia
Study officials:
affiliation: Riphah International University
name: Wajeeha Zia, MSPT
role: PRINCIPAL_INVESTIGATOR
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