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

8. August 2021 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

30

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Truthahn
      • Ankara, Truthahn
        • Hacettepe University, Faculty of Physical Therapy and Rehabilitation
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Sonstiges: 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.
Experimental: 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.
Sonstiges: 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.
Experimental: 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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Evaluation of Disease Activity
Zeitfenster: 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
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Evaluation of Spinal Mobility and Hip Function
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hacettepe University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Voraussichtlich)

1. Oktober 2021

Primärer Abschluss (Voraussichtlich)

1. Dezember 2022

Studienabschluss (Voraussichtlich)

1. Mai 2023

Studienanmeldedaten

Zuerst eingereicht

8. August 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. August 2021

Zuerst gepostet (Tatsächlich)

16. August 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. August 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. August 2021

Zuletzt verifiziert

1. August 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • KA-21035

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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