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

2021년 8월 8일 업데이트: Nur Banu Karaca, Hacettepe University

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

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.

연구 개요

상태

아직 모집하지 않음

연구 유형

중재적

등록 (예상)

30

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

      • Ankara, 칠면조
        • Hacettepe University, Faculty of Physical Therapy and Rehabilitation
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Telerehabilitation Training Group

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.

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.
실험적: Face-to-Face Training Group

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.

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.
실험적: Home-Based Training Group

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.

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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Evaluation of Disease Activity
기간: 3 minutes, through study completion, an average of 8 weeks, change from baseline disease activity at 8 weeks.
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.
Evaluation of Functional Level
기간: 5 minutes, through study completion, an average of 8 weeks, change from baseline functional level at 8 weeks.
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.

2차 결과 측정

결과 측정
측정값 설명
기간
Evaluation of Spinal Mobility and Hip Function
기간: 10 minutes, through study completion, an average of 8 weeks, change from baseline spinal mobility and hip function at 8 weeks.
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.
Assessment of Health and Disability Status
기간: 5 minutes, through study completion, an average of 8 weeks, change from baseline health and disability status at 8 weeks.
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.
Evaluation of Quality of Life
기간: 5 minutes, through study completion, an average of 8 weeks, change from baseline quality of life at 8 weeks.
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.
5 minutes, through study completion, an average of 8 weeks, change from baseline quality of life at 8 weeks.
Evaluation of Biopsychosocial Status
기간: 10 minutes, through study completion, an average of 8 weeks, change from baseline biopsychosocial status at 8 weeks.
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.
Evaluation of Depression and Anxiety Levels
기간: 7 minutes, through study completion, an average of 8 weeks, change from baseline depression and anxiety levels at 8 weeks.
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.
Evaluation of Physical Activity Level
기간: 5 minutes, through study completion, an average of 8 weeks, change from baseline physical activity level at 8 weeks.

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.

5 minutes, through study completion, an average of 8 weeks, change from baseline physical activity level at 8 weeks.
Evaluation of Kinesiophobia
기간: 5 minutes, through study completion, an average of 8 weeks, change from baseline kinesiophobia at 8 weeks
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.
5 minutes, through study completion, an average of 8 weeks, change from baseline kinesiophobia at 8 weeks
Evaluation of Illness Perception
기간: 3 minutes, through study completion, an average of 8 weeks, change from baseline illness perception at 8 weeks.

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.

3 minutes, through study completion, an average of 8 weeks, change from baseline illness perception at 8 weeks.
Evaluation of Central Sensitization
기간: 5 minutes, through study completion, an average of 8 weeks, change from baseline central sensitization at 8 weeks
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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (예상)

2021년 10월 1일

기본 완료 (예상)

2022년 12월 1일

연구 완료 (예상)

2023년 5월 1일

연구 등록 날짜

최초 제출

2021년 8월 8일

QC 기준을 충족하는 최초 제출

2021년 8월 8일

처음 게시됨 (실제)

2021년 8월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 8월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 8월 8일

마지막으로 확인됨

2021년 8월 1일

추가 정보

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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Spinal stabilization exercise에 대한 임상 시험

3
구독하다