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Telerehabilitation, Face-to-Face and Home-Based Spinal Stabilization Exercise Training in Patients With Spondyloarthritis

Primary Purpose

Spondyloarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Spinal stabilization exercise
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondyloarthritis focused on measuring spinal stabilization exercise, tele-rehabilitation, spondyloarthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with spondyloarthritis
  • Between the ages of 18-65,
  • Literate,
  • Having sufficient smartphone/computer knowledge to participate in the study or having a relative who can help in this regard,
  • Having a smart phone/computer and an active internet connection,
  • Individuals who have not exercised regularly in at least the last 3 months will be included in the study.

Exclusion Criteria:

  • Having a diagnosis of uncontrolled/clinically significant other disease (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.),
  • Malignancies
  • Having a history of previous surgery on the spine and extremities and therefore loss of function,
  • Pregnant individuals,
  • Continuing another rehabilitation program,
  • Have other conditions that prevent exercise,
  • Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.

Sites / Locations

  • Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Telerehabilitation Training Group

Face-to-Face Training Group

Home-Based Training Group

Arm Description

In the telerehabilitation group, an individualized rehabilitation program according to the principles of spinal stabilization exercises will be applied via video conference, 3 days a week, 1 hour, online in real-time, accompanied by a physiotherapist, for 8 weeks. In the first session, informative training about the disease (pathophysiology of spondyloarthritis, its course, physical structures it covers, etc.), pain management training (information about the relationship between pain, muscle spasm, stress, depression, methods that can be used for coping with pain, etc.), exercise. The importance of exercise training (trunk stabilization, anatomy) and aims will be given within the scope of patient education.

In the face-to-face training group, an individualized rehabilitation program according to the principles of spinal stabilization exercises will be applied in the clinic under the supervision of a physiotherapist for 1 hour, 3 days a week, for 8 weeks. In the first session, informative training about the disease (pathophysiology of spondyloarthritis, its course, physical structures it covers, etc.), pain management training (information about the relationship between pain, muscle spasm, stress, depression, methods that can be used for coping with pain, etc.), exercise. The importance of exercise training (trunk stabilization, anatomy) and aims will be given within the scope of patient education.

In the home exercise group, patients will be asked to perform individualized spinal stabilization exercises at home, 3 days a week, for 8 weeks. In the first session, informative training about the disease (pathophysiology of spondyloarthritis, its course, physical structures it covers, etc.), pain management training (information about the relationship between pain, muscle spasm, stress, depression, methods that can be used for coping with pain, etc.), exercise. The importance of exercise training (trunk stabilization, anatomy) and aims will be given within the scope of patient education.

Outcomes

Primary Outcome Measures

Evaluation of Disease Activity
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): The index consists of 6 items questioning 5 symptoms in total. The response of each item is evaluated with the Visual Analog Scale (VAS). A total score of ≥ 4 indicates active disease. Turkish version study Akkoç et al. made by.
Evaluation of Functional Level
Bath Ankylosing Spondylitis Functional Index (BASFI): The index consists of 10 questions in total. For each item, the patient marks the VAS consisting of a 100 mm line. The score range is 0-100. The Turkish version study was conducted by Karatepe et al. made by. A high score indicates a bad result.

Secondary Outcome Measures

Evaluation of Spinal Mobility and Hip Function
Bath Ankylosing Spondylitis Metrology Index (BASMI): The index, which consists of five clinical measurements, namely cervical rotation, tragus-wall distance, lumbar lateral flexion, modified Schober's test, and intermalleolar distance, is accepted as the most valid method for evaluating the axial skeleton. The higher the BASMI score the more severe the patient's limitation of movement.
Assessment of Health and Disability Status
Health Assessment Questionnaire (HAQ): It consists of 20 questions that question daily activities under 8 headings. Each question is scored between 0-3 by the patient. The total score ranges from 0-3. Turkish version study Küçükdeveci et al. made by. A high score indicates a bad result.
Evaluation of Quality of Life
Short Form-36 (SF-36): SF-36, which is one of the most commonly used general scales to measure the quality of life, consists of eight sub-dimensions: physical function, social function, role limitations due to physical problems, role limitations due to emotional status, pain, vitality, mental health, and general health perception. Each sub-dimension is scored between 0-100 in itself. A high score indicates good health. The Turkish version study was conducted by Koçyiğit et al. made by.
Evaluation of Biopsychosocial Status
BETY-Biopsychosocial Questionnaire (BETY-BQ): Each of the questions in this scale, which consists of 30 different cognitive belief statements, is scored between 0-4. The total score ranges from 0 to 120. A high score indicates a poor biopsychosocial level. It is a scale developed by Ünal et al.
Evaluation of Depression and Anxiety Levels
This scale consisting of 14 questions, odd-numbered questions question anxiety and even questions question depression. The options take values between 0-3, with a high score indicating a bad emotional state. The cut-off values of the scale were determined as 10 for the anxiety subscale and 7 for the depression subscale. The Turkish version study was done by Aydemir et al.
Evaluation of Physical Activity Level
International Physical Activity Questionnaire (IPAQ)-Short Form: There are eight versions of the questionnaire in total, but the short form "last 7 days" will be used in this study. The short form (7 questions) provides information about the time spent in walking, moderate-to-vigorous and vigorous activities. The time spent sitting is considered a separate question. It is classified as low, medium, and high level by calculating the activity level of the person in terms of METs according to the duration, frequency, and intensity level of the movement. The Turkish version study was done by Sağlam et al.
Evaluation of Kinesiophobia
Tampa Kinesophobia Scale (TCS): It is a 17-question scale that evaluates injury avoidance and fear of movement, and Kori et al. developed by. The Turkish version is from Tunca-Yılmaz et al. Made by. Its scoring is scored with "1 = Strongly disagree, 4 = Strongly agree". The score is calculated by reversing items 4, 8, 12, and 16. The total score is between 17 and 68. It is understood that the higher the score, the higher the kinesophobia. A total score of more than 37 is considered to be a high degree of kinesophobia.
Evaluation of Illness Perception
Brief Illness Perception Scale (BIPQ): In this scale, which consists of 9 questions, each question evaluates a component of the perception of illness. The first eight questions take values between 0-10. A high score indicates an increased level of perception of the disease as worrisome. The total score ranges from 0 to 80. The ninth question is an open-ended question that questions the patient's opinion about the possible causes of the disease. Turkish validity and reliability study was done by Karataş et al.
Evaluation of Central Sensitization
Central Sensitization Scale (CSS): It consists of 25 questions. The symptoms associated with central sensitization are questioned. Above 40 points is interpreted as an indicator of central sensitization. Turkish validity and reliability study was conducted by Düzce et al.

Full Information

First Posted
August 8, 2021
Last Updated
August 8, 2021
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05006690
Brief Title
Telerehabilitation, Face-to-Face and Home-Based Spinal Stabilization Exercise Training in Patients With Spondyloarthritis
Official Title
Comparison of the Effects of Telerehabilitation, Face-to-Face and Home-Based Spinal Stabilization Exercise Training in Patients With Spondyloarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2021 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Spondyloarthritis (SpA) refers to a group of rheumatic diseases with common clinical, genetic, and imaging features. In addition to the pain caused by sacroiliitis and spondylitis, which are the main complaints, patients often experience joint stiffness, fatigue, mood disorders, and various degrees of functional limitations, and their quality of life can be significantly affected. On the other hand, the COVID-19 pandemic reduces the level of physical activity in this patient group and negatively affects individuals psychologically. For this reason, telerehabilitation has come to the fore all over the world and rheumatology associations have also recommended these services. Although there is consensus about the positive effects of exercise in SpA, no exercise regimen has been shown to be superior to the other. There is no study examining the effects of exercise training applied with telerehabilitation on individuals with SpA. The aim of this study is to compare the effects of telerehabilitation and face-to-face and home-based spinal stabilization exercise training in individuals with SpA. Volunteers meeting the inclusion criteria will be randomly divided into 3 groups: 'telerehabilitation training group', 'face-to-face training group' and 'home-based training group'. The individualized rehabilitation program will be applied to each group for 1 hour, 3 days a week, for 8 weeks. Patient-reported scales assessing patients' disease activity, functionality, mood, physical activity, quality of life, fear-avoidance, central sensitization levels, and perceptions of the disease will be administered to individuals at baseline, after the 8-week rehabilitation program, and 6 months after the second evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthritis
Keywords
spinal stabilization exercise, tele-rehabilitation, spondyloarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation Training Group
Arm Type
Experimental
Arm Description
In the telerehabilitation group, an individualized rehabilitation program according to the principles of spinal stabilization exercises will be applied via video conference, 3 days a week, 1 hour, online in real-time, accompanied by a physiotherapist, for 8 weeks. In the first session, informative training about the disease (pathophysiology of spondyloarthritis, its course, physical structures it covers, etc.), pain management training (information about the relationship between pain, muscle spasm, stress, depression, methods that can be used for coping with pain, etc.), exercise. The importance of exercise training (trunk stabilization, anatomy) and aims will be given within the scope of patient education.
Arm Title
Face-to-Face Training Group
Arm Type
Experimental
Arm Description
In the face-to-face training group, an individualized rehabilitation program according to the principles of spinal stabilization exercises will be applied in the clinic under the supervision of a physiotherapist for 1 hour, 3 days a week, for 8 weeks. In the first session, informative training about the disease (pathophysiology of spondyloarthritis, its course, physical structures it covers, etc.), pain management training (information about the relationship between pain, muscle spasm, stress, depression, methods that can be used for coping with pain, etc.), exercise. The importance of exercise training (trunk stabilization, anatomy) and aims will be given within the scope of patient education.
Arm Title
Home-Based Training Group
Arm Type
Experimental
Arm Description
In the home exercise group, patients will be asked to perform individualized spinal stabilization exercises at home, 3 days a week, for 8 weeks. In the first session, informative training about the disease (pathophysiology of spondyloarthritis, its course, physical structures it covers, etc.), pain management training (information about the relationship between pain, muscle spasm, stress, depression, methods that can be used for coping with pain, etc.), exercise. The importance of exercise training (trunk stabilization, anatomy) and aims will be given within the scope of patient education.
Intervention Type
Other
Intervention Name(s)
Spinal stabilization exercise
Intervention Description
Spinal stabilization exercises aim at controlling the position of the trunk over the pelvis to provide optimal energy production and energy transfer to distal segments and involve the cocontraction of muscles, which may restore stability to the spine.
Primary Outcome Measure Information:
Title
Evaluation of Disease Activity
Description
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): The index consists of 6 items questioning 5 symptoms in total. The response of each item is evaluated with the Visual Analog Scale (VAS). A total score of ≥ 4 indicates active disease. Turkish version study Akkoç et al. made by.
Time Frame
3 minutes, through study completion, an average of 8 weeks, change from baseline disease activity at 8 weeks.
Title
Evaluation of Functional Level
Description
Bath Ankylosing Spondylitis Functional Index (BASFI): The index consists of 10 questions in total. For each item, the patient marks the VAS consisting of a 100 mm line. The score range is 0-100. The Turkish version study was conducted by Karatepe et al. made by. A high score indicates a bad result.
Time Frame
5 minutes, through study completion, an average of 8 weeks, change from baseline functional level at 8 weeks.
Secondary Outcome Measure Information:
Title
Evaluation of Spinal Mobility and Hip Function
Description
Bath Ankylosing Spondylitis Metrology Index (BASMI): The index, which consists of five clinical measurements, namely cervical rotation, tragus-wall distance, lumbar lateral flexion, modified Schober's test, and intermalleolar distance, is accepted as the most valid method for evaluating the axial skeleton. The higher the BASMI score the more severe the patient's limitation of movement.
Time Frame
10 minutes, through study completion, an average of 8 weeks, change from baseline spinal mobility and hip function at 8 weeks.
Title
Assessment of Health and Disability Status
Description
Health Assessment Questionnaire (HAQ): It consists of 20 questions that question daily activities under 8 headings. Each question is scored between 0-3 by the patient. The total score ranges from 0-3. Turkish version study Küçükdeveci et al. made by. A high score indicates a bad result.
Time Frame
5 minutes, through study completion, an average of 8 weeks, change from baseline health and disability status at 8 weeks.
Title
Evaluation of Quality of Life
Description
Short Form-36 (SF-36): SF-36, which is one of the most commonly used general scales to measure the quality of life, consists of eight sub-dimensions: physical function, social function, role limitations due to physical problems, role limitations due to emotional status, pain, vitality, mental health, and general health perception. Each sub-dimension is scored between 0-100 in itself. A high score indicates good health. The Turkish version study was conducted by Koçyiğit et al. made by.
Time Frame
5 minutes, through study completion, an average of 8 weeks, change from baseline quality of life at 8 weeks.
Title
Evaluation of Biopsychosocial Status
Description
BETY-Biopsychosocial Questionnaire (BETY-BQ): Each of the questions in this scale, which consists of 30 different cognitive belief statements, is scored between 0-4. The total score ranges from 0 to 120. A high score indicates a poor biopsychosocial level. It is a scale developed by Ünal et al.
Time Frame
10 minutes, through study completion, an average of 8 weeks, change from baseline biopsychosocial status at 8 weeks.
Title
Evaluation of Depression and Anxiety Levels
Description
This scale consisting of 14 questions, odd-numbered questions question anxiety and even questions question depression. The options take values between 0-3, with a high score indicating a bad emotional state. The cut-off values of the scale were determined as 10 for the anxiety subscale and 7 for the depression subscale. The Turkish version study was done by Aydemir et al.
Time Frame
7 minutes, through study completion, an average of 8 weeks, change from baseline depression and anxiety levels at 8 weeks.
Title
Evaluation of Physical Activity Level
Description
International Physical Activity Questionnaire (IPAQ)-Short Form: There are eight versions of the questionnaire in total, but the short form "last 7 days" will be used in this study. The short form (7 questions) provides information about the time spent in walking, moderate-to-vigorous and vigorous activities. The time spent sitting is considered a separate question. It is classified as low, medium, and high level by calculating the activity level of the person in terms of METs according to the duration, frequency, and intensity level of the movement. The Turkish version study was done by Sağlam et al.
Time Frame
5 minutes, through study completion, an average of 8 weeks, change from baseline physical activity level at 8 weeks.
Title
Evaluation of Kinesiophobia
Description
Tampa Kinesophobia Scale (TCS): It is a 17-question scale that evaluates injury avoidance and fear of movement, and Kori et al. developed by. The Turkish version is from Tunca-Yılmaz et al. Made by. Its scoring is scored with "1 = Strongly disagree, 4 = Strongly agree". The score is calculated by reversing items 4, 8, 12, and 16. The total score is between 17 and 68. It is understood that the higher the score, the higher the kinesophobia. A total score of more than 37 is considered to be a high degree of kinesophobia.
Time Frame
5 minutes, through study completion, an average of 8 weeks, change from baseline kinesiophobia at 8 weeks
Title
Evaluation of Illness Perception
Description
Brief Illness Perception Scale (BIPQ): In this scale, which consists of 9 questions, each question evaluates a component of the perception of illness. The first eight questions take values between 0-10. A high score indicates an increased level of perception of the disease as worrisome. The total score ranges from 0 to 80. The ninth question is an open-ended question that questions the patient's opinion about the possible causes of the disease. Turkish validity and reliability study was done by Karataş et al.
Time Frame
3 minutes, through study completion, an average of 8 weeks, change from baseline illness perception at 8 weeks.
Title
Evaluation of Central Sensitization
Description
Central Sensitization Scale (CSS): It consists of 25 questions. The symptoms associated with central sensitization are questioned. Above 40 points is interpreted as an indicator of central sensitization. Turkish validity and reliability study was conducted by Düzce et al.
Time Frame
5 minutes, through study completion, an average of 8 weeks, change from baseline central sensitization at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with spondyloarthritis Between the ages of 18-65, Literate, Having sufficient smartphone/computer knowledge to participate in the study or having a relative who can help in this regard, Having a smart phone/computer and an active internet connection, Individuals who have not exercised regularly in at least the last 3 months will be included in the study. Exclusion Criteria: Having a diagnosis of uncontrolled/clinically significant other disease (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.), Malignancies Having a history of previous surgery on the spine and extremities and therefore loss of function, Pregnant individuals, Continuing another rehabilitation program, Have other conditions that prevent exercise, Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nur B Karaca
Phone
+905448844755
Email
nurturkmen90@gmail.com
Facility Information:
Facility Name
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
City
Ankara
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Özlem Ülger, professor
Phone
+905324027876
Email
ozlem.ulger@hacettepe.edu.tr

12. IPD Sharing Statement

Learn more about this trial

Telerehabilitation, Face-to-Face and Home-Based Spinal Stabilization Exercise Training in Patients With Spondyloarthritis

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