- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05019547
The Turkish Version of the Inflammatory Arthritis Facilitators and Barriers to Physical Activity
December 28, 2021 updated by: Özgül Öztürk, Acibadem University
Validity and Reliability of the Turkish Version of the Inflammatory Arthritis Facilitators and Barriers to Physical Activity
Our aim in this study is to translate the Inflammatory Arthritis Facilitators and Barriers to Physical Activity (IFAB) Questionnaire which was developed to determine the factors that facilitate and prevent individuals for physical activity for patients with inflammatory arthritis into Turkish language.
Also, our aim is to evaluate the validity and reliability of the IFAB Questionnaire in the Turkish population, and to perform a cultural adaptation if necessary at the same time.
Determining the factors that facilitate and prevent individuals for physical activity interventions with rheumatic diseases and then designing physical activity programs considering these factors may play an important role in reducing the symptoms caused by the disease and increasing their quality of life.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
93
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey
- Haydarpasa Numune Research and Training Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Axial Spondyloarthritis
Description
Inclusion Criteria:
- Being 18 years or older,
- Diagnosed with Axial Spondyloarthritis by an experienced rheumatologist
- To have the neurological competence and cognitive level to answer the scale questions.
Exclusion Criteria:
- Having a rheumatological disease other than Axial Spondyloarthritis ,
- Using an assistive device for walking.
- Any verbal or written communication problems in Turkish,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Axial Spondyloarthritis
Participants with Axial Spondyloarthritis
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Determining Barriers and Facilitators of Physical Activity
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inflammatory Arthritis Barriers and Facilitators to Physical Activity Questionnaire (IFAB)
Time Frame: 1 day
|
The IFAB Questionnaire was developed by Davergne et al. in 2020 and aims to evaluate the factors that facilitate or prevent physical activity in individuals with inflammatory arthritis.
The IFAB questionnaire consists of 10 items.
Of these 10 items, 4 were identified as potential barriers or facilitators, 3 as only barriers and 3 as only facilitators.
The participant is asked to rate how much the item facilitates or prevents from physical activity between 0 and 10, "0" has no effect on physical activity, and "10" has maximum (negative or positive) effect on physical activity.
A high score from the questionnaire indicates that the facilitators are at a high level and the barriers are at a low level.
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1 day
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The Exercise Benefits or Barriers Scale
Time Frame: 1 day
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The Exercise Benefits and Barriers Scale has been developed by Sechrist et al. and the Turkish validity and reliability studies were conducted by Ortabağ et al.
This scale will be used to evaluate criterion validity which evaluates the benefits and barriers of exercise perceived by the individual on a 4-point Likert-type scale with 43 questions.
Scoring is performed as barrier score, benefit score and total score.
A low score means less perceived barriers to exercise and greater benefits.
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1 day
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International Physical Activity Questionnaire - Short Form
Time Frame: 1 day
|
The physical activity level reported by the participants will be evaluated with the International Physical Activity Questionnaire - Short Form.
The International Physical Activity Questionnaire - Short Form questions the time spent walking, moderate and vigorous activities, and sitting with 7 questions.
The duration (minutes) and frequency (days) of each activity are questioned.
The physical activity levels of the participants will be classified as inactive, minimally active and very active according to the results.
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 1 day
|
The HADS scale was developed to assess anxiety and depression in individuals without psychiatric illness.
Of the 14-item questionnaire, 7 questions assess depression and 7 questions assess anxiety and each response consists of a four-point rating scale (0 to 3); a higher score indicates a worse condition.For each subscale the total score is at most 21.
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1 day
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Health Assessment Questionnaire - Disability Index
Time Frame: 1 day
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This questionnaire evaluates the level of functional disability in patients with rheumatological disease over 20 questions.
It determines the level of difficulty of the person during the activities that are most frequently performed in daily life such as dressing, eating, hygiene, walking, sitting up, reaching and grasping.
A high score indicates a low level of functionality.
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1 day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Actual)
December 10, 2021
Study Completion (Actual)
December 10, 2021
Study Registration Dates
First Submitted
August 19, 2021
First Submitted That Met QC Criteria
August 19, 2021
First Posted (Actual)
August 25, 2021
Study Record Updates
Last Update Posted (Actual)
December 29, 2021
Last Update Submitted That Met QC Criteria
December 28, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATADEK 2021 - 15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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