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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey
      • Istanbul, Turkey
        • Haydarpasa Numune Research and Training Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Axial Spondyloarthritis
Participants with Axial Spondyloarthritis
Behavioral: Determining Barriers and Facilitators of Physical Activity
Determining Barriers and Facilitators of Physical Activity

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
1 day
The Exercise Benefits or Barriers Scale
Time Frame: 1 day
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.
1 day
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.
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
1 day
Health Assessment Questionnaire - Disability Index
Time Frame: 1 day
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Acibadem University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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