NCT05019547

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 19, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
Last Updated

December 29, 2021

Status Verified

December 1, 2021

Enrollment Period

3 months

First QC Date

August 19, 2021

Last Update Submit

December 28, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Inflammatory Arthritis Barriers and Facilitators to Physical Activity Questionnaire (IFAB)

    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

    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

    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 Outcomes (2)

  • Hospital Anxiety and Depression Scale (HADS)

    1 day

  • Health Assessment Questionnaire - Disability Index

    1 day

Study Arms (1)

Axial Spondyloarthritis

Participants with Axial Spondyloarthritis

Behavioral: Determining Barriers and Facilitators of Physical Activity

Interventions

Determining Barriers and Facilitators of Physical Activity

Axial Spondyloarthritis

Eligibility Criteria

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

Axial Spondyloarthritis

You may qualify if:

  • 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.

You may not qualify if:

  • Having a rheumatological disease other than Axial Spondyloarthritis ,
  • Using an assistive device for walking.
  • Any verbal or written communication problems in Turkish,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haydarpasa Numune Research and Training Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Ozturk O, Feyzioglu O, Saritas F. Inflammatory Arthritis Facilitators and Barriers (IFAB) for physical activity questionnaire: cross-cultural adaptation into Turkish and evaluation of its psychometric properties. Disabil Rehabil. 2023 Aug;45(17):2818-2825. doi: 10.1080/09638288.2022.2104940. Epub 2022 Aug 1.

MeSH Terms

Conditions

Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 19, 2021

First Posted

August 25, 2021

Study Start

September 1, 2021

Primary Completion

December 10, 2021

Study Completion

December 10, 2021

Last Updated

December 29, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations