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

Spondyloarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05006690
• Other study ID #: KA-21035
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2021
• Est. completion date: May 2023

Study information

• Verified date: August 2021
• Source: Hacettepe University
• Contact: Nur B Karaca
• Phone: +905448844755
• Email: nurturkmen90[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spondylarthritis
• Spondyloarthritis

Intervention

Other:
• Spinal stabilization exercise
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.

Locations

Country	Name	City	State
Turkey	Hacettepe University, Faculty of Physical Therapy and Rehabilitation	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 minutes, through study completion, an average of 8 weeks, change from baseline disease activity at 8 weeks.
Primary	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.	5 minutes, through study completion, an average of 8 weeks, change from baseline functional level at 8 weeks.
Secondary	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.	10 minutes, through study completion, an average of 8 weeks, change from baseline spinal mobility and hip function at 8 weeks.
Secondary	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.	5 minutes, through study completion, an average of 8 weeks, change from baseline health and disability status at 8 weeks.
Secondary	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 Koçyigit et al. made by.	5 minutes, through study completion, an average of 8 weeks, change from baseline quality of life at 8 weeks.
Secondary	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.	10 minutes, through study completion, an average of 8 weeks, change from baseline biopsychosocial status at 8 weeks.
Secondary	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.	7 minutes, through study completion, an average of 8 weeks, change from baseline depression and anxiety levels at 8 weeks.
Secondary	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 Saglam et al.	5 minutes, through study completion, an average of 8 weeks, change from baseline physical activity level at 8 weeks.
Secondary	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-Yilmaz 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.	5 minutes, through study completion, an average of 8 weeks, change from baseline kinesiophobia at 8 weeks
Secondary	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 Karatas et al.	3 minutes, through study completion, an average of 8 weeks, change from baseline illness perception at 8 weeks.
Secondary	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.	5 minutes, through study completion, an average of 8 weeks, change from baseline central sensitization at 8 weeks