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Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis

2 listopada 2026 zaktualizowane przez: Gamze TAŞDELEN, Sisli Hamidiye Etfal Training and Research Hospital

Clinical and Ultrasonographic Evaluation of the Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis: A Prospective Randomized Controlled Study

This prospective, randomized, single-blind controlled study aims to evaluate the effects of resistance exercises on clinical and ultrasonographic findings of enthesitis in patients with spondyloarthritis. Participants were randomly assigned to two groups. The intervention group performs resistance exercises in addition to a walking program, while the control group follows a walking program alone. Patients in the intervention group undergo resistance exercise sessions three days per week for 12 weeks. The primary outcomes are changes in ultrasonographic enthesitis scores measured using the Madrid Sonographic Enthesitis Index (MASEI) and Glasgow Ultrasound Enthesitis Scoring System (GUESS). Secondary outcomes include tendon stiffness assessed by shear-wave elastography, clinical enthesitis scores, disease activity, physical function, and quality of life. Outcomes are assessed at baseline and at week 12.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Szczegółowy opis

Spondyloarthritis is a chronic inflammatory rheumatic disease that can affect the spine, peripheral joints, and entheses. Enthesitis, characterized by inflammation at the sites where tendons and ligaments attach to bone, is an important feature of the disease. Although exercise is a fundamental component of spondyloarthritis management, its effects on ultrasonographic findings of enthesitis remain unclear. This study aims to investigate the effects of resistance exercises on ultrasonographic entheseal findings, tendon stiffness, and clinical outcomes in patients with spondyloarthritis.

This single-center, prospective, randomized, single-blind controlled study is being conducted at the Physical Medicine and Rehabilitation Clinic of Sisli Hamidiye Etfal Training and Research Hospital. Patients diagnosed with spondyloarthritis are randomly allocated to an intervention group or a control group using the National Cancer Institute Clinical Trial Randomization Tool.

The intervention group follows a 12-week resistance exercise program using TheraBand® resistance bands in addition to a walking program, while the control group follows a walking program alone. Resistance exercises are performed three days per week, including two supervised sessions at the hospital. Each session lasts approximately 30-40 minutes and consists of warm-up activities, upper- and lower-extremity strengthening exercises, and cool-down exercises. Strengthening exercises are performed in 2-3 sets of 10-15 repetitions, with resistance progressively increased according to individual tolerance.

The primary outcomes are changes in ultrasonographic enthesitis scores assessed using the Madrid Sonographic Enthesitis Index (MASEI) and the Glasgow Ultrasound Enthesitis Scoring System (GUESS).

Secondary outcomes include tendon stiffness measurements of the Achilles and patellar tendons assessed by shear-wave elastography; clinical enthesitis assessed using the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) and the Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC); disease activity evaluated using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Ankylosing Spondylitis Disease Activity Score based on C-reactive protein (ASDAS-CRP) and erythrocyte sedimentation rate (ASDAS-ESR); physical function assessed using the Bath Ankylosing Spondylitis Functional Index (BASFI); quality of life assessed using the Ankylosing Spondylitis Quality of Life questionnaire (ASQoL); Patient Global Assessment measured using the Visual Analog Scale (VAS); and inflammatory markers, including erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP).

Clinical and ultrasonographic assessments are performed at baseline and at week 12. Ultrasonographic evaluations are conducted by the same physician, who is blinded to the participants' group allocation.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

48

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Turcja (Türkiye)
      • Istanbul, Turcja (Türkiye)
        • Sisli Hamidiye Etfal Training and Research Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 65 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Adults aged 18-65 years.
  • Diagnosis of spondyloarthritis (SpA) fulfilling the Assessment of SpondyloArthritis International Society (ASAS) classification criteria.
  • Baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score below 4.
  • No initiation of a new biologic agent within the preceding three months and continuation of existing medical treatment.
  • Absence of any physical or neurological condition that would prevent participation in the exercise program.
  • Willingness to participate in the study and provision of written informed consent.

Exclusion Criteria:

  • Initiation of biologic therapy or dose modification of an existing biologic agent within the preceding three months.
  • Presence of a systemic infection.
  • Pregnancy or breastfeeding.
  • Presence of malignancy.
  • Orthopedic or cardiopulmonary conditions that may contraindicate exercise.
  • Neurological disorders causing motor dysfunction.
  • Corticosteroid injection into any of the entheseal sites to be evaluated within the preceding six weeks.
  • Presence of infection, open wounds, or peripheral neuropathy at the anatomical sites to be assessed.
  • History of surgery, trauma, or malformation at the anatomical sites to be evaluated.
  • Presence of another concomitant rheumatic disease.
  • Use of fluoroquinolones, retinoids, or fluoride.
  • Diagnosis of fibromyalgia syndrome (FMS) or clinical findings suggestive of FMS during assessment.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Walking Control Group

Participants in the control group were instructed to continue their usual daily physical activities and maintain their existing medical treatments. They were also assigned a walking program consisting of 30-minute sessions twice per week for 12 weeks. No additional resistance exercises were provided.
Inny: Walking program

A walking program consisting of 30-minute sessions twice per week for 12 weeks. Participants continued their usual daily physical activities and maintained their existing medical treatments throughout the study.
Eksperymentalny: Combined Walking and Resistance Exercise Group

Participants in the intervention group were instructed to continue their usual daily physical activities and maintain their existing medical treatments. They followed a walking program consisting of 30-minute sessions twice per week for 12 weeks, in addition to a resistance exercise program using TheraBand® resistance bands three days per week for 12 weeks. Two resistance exercise sessions per week were supervised at the hospital, and each session lasted approximately 30-40 minutes.
Inny: Walking program

A walking program consisting of 30-minute sessions twice per week for 12 weeks. Participants continued their usual daily physical activities and maintained their existing medical treatments throughout the study.

Inny: Resistance Exercise Program

Participants in the intervention group received a 12-week resistance exercise program using TheraBand® resistance bands in addition to a walking program. Resistance exercises were performed three days per week, including two supervised sessions at the hospital. Each session lasted approximately 30-40 minutes and included warm-up, upper- and lower-extremity strengthening, and cool-down exercises. Participants performed 2-3 sets of 10-15 repetitions, with resistance progressively increased according to individual tolerance.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Madrid Sonographic Enthesitis Index (MASEI) Score
Ramy czasowe: Baseline (pre-intervention) and post-intervention (12 weeks)

The Madrid Sonographic Enthesitis Index (MASEI) assesses inflammatory and structural abnormalities at entheseal sites using ultrasonography. Total scores range from 0 to 136, with higher scores indicating more pronounced entheseal abnormalities. Changes in total scores from baseline to post-intervention are evaluated.
Baseline (pre-intervention) and post-intervention (12 weeks)
Change in Glasgow Ultrasound Enthesitis Scoring System (GUESS) Score
Ramy czasowe: Baseline (pre-intervention) and post-intervention (12 weeks)

The Glasgow Ultrasound Enthesitis Scoring System (GUESS) assesses entheseal abnormalities in the lower extremities using ultrasonography, including tendon thickening, enthesophytes, erosions, and bursitis. Total scores range from 0 to 36, with higher scores indicating more pronounced entheseal abnormalities. Changes in total scores from baseline to post-intervention are evaluated.
Baseline (pre-intervention) and post-intervention (12 weeks)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Achilles Tendon Stiffness Assessed by Shear-Wave Elastography
Ramy czasowe: Baseline (pre-intervention) and post-intervention (12 weeks)

Achilles tendon stiffness is assessed using shear-wave elastography. Five measurements are obtained at each assessment, and the mean values are recorded in both kilopascals (kPa) and meters per second (m/s). Changes from baseline to post-intervention are evaluated.
Baseline (pre-intervention) and post-intervention (12 weeks)
Change in Patellar Tendon Stiffness Assessed by Shear-Wave Elastography
Ramy czasowe: Baseline (pre-intervention) and post-intervention (12 weeks)

Patellar tendon stiffness is assessed using shear-wave elastography. Five measurements are obtained at each assessment, and the mean values are recorded in both kilopascals (kPa) and meters per second (m/s). Changes from baseline to post-intervention are evaluated.
Baseline (pre-intervention) and post-intervention (12 weeks)
Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
Ramy czasowe: Baseline (pre-intervention) and post-intervention (12 weeks)

The Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) assesses clinical enthesitis by evaluating tenderness at 13 entheseal sites. Total scores range from 0 to 13, with higher scores indicating greater entheseal tenderness. Changes in total scores from baseline to post-intervention are evaluated.
Baseline (pre-intervention) and post-intervention (12 weeks)
Change in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
Ramy czasowe: Baseline (pre-intervention) and post-intervention (12 weeks)

The Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index assesses clinical enthesitis by evaluating tenderness at 16 entheseal sites. Total scores range from 0 to 16, with higher scores indicating greater entheseal tenderness. Changes in total scores from baseline to post-intervention are evaluated.
Baseline (pre-intervention) and post-intervention (12 weeks)
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
Ramy czasowe: Baseline (pre-intervention) and post-intervention (12 weeks)

The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) assesses disease activity based on fatigue, spinal pain, peripheral joint pain and swelling, enthesitis-related discomfort, and morning stiffness. Total scores range from 0 to 10, with higher scores indicating greater disease activity. Changes in total scores from baseline to post-intervention are evaluated.
Baseline (pre-intervention) and post-intervention (12 weeks)
Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
Ramy czasowe: Baseline (pre-intervention) and post-intervention (12 weeks)

The Bath Ankylosing Spondylitis Functional Index (BASFI) assesses physical function and limitations in daily activities in patients with spondyloarthritis. Total scores range from 0 to 10, with higher scores indicating greater functional impairment. Changes in total scores from baseline to post-intervention are evaluated.
Baseline (pre-intervention) and post-intervention (12 weeks)
Change in Ankylosing Spondylitis Quality of Life (ASQoL) Score
Ramy czasowe: Baseline (pre-intervention) and post-intervention (12 weeks)

The Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire assesses the impact of spondyloarthritis on patients' quality of life using 18 items. Total scores range from 0 to 18, with higher scores indicating poorer quality of life. Changes in total scores from baseline to post-intervention are evaluated.
Baseline (pre-intervention) and post-intervention (12 weeks)
Change in Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS-CRP)
Ramy czasowe: Baseline (pre-intervention) and post-intervention (12 weeks)

The Ankylosing Spondylitis Disease Activity Score using C-reactive protein (ASDAS-CRP) assesses disease activity based on patient-reported symptoms and serum C-reactive protein levels. Scores below 1.3 indicate inactive disease, 1.3 to less than 2.1 indicate low disease activity, 2.1 to 3.5 indicate high disease activity, and scores above 3.5 indicate very high disease activity. Changes in scores from baseline to post-intervention are evaluated.
Baseline (pre-intervention) and post-intervention (12 weeks)
Change in Ankylosing Spondylitis Disease Activity Score Using Erythrocyte Sedimentation Rate (ASDAS-ESR)
Ramy czasowe: Baseline (pre-intervention) and post-intervention (12 weeks)

The Ankylosing Spondylitis Disease Activity Score using erythrocyte sedimentation rate (ASDAS-ESR) assesses disease activity based on patient-reported symptoms and erythrocyte sedimentation rate. Scores below 1.3 indicate inactive disease, 1.3 to less than 2.1 indicate low disease activity, 2.1 to 3.5 indicate high disease activity, and scores above 3.5 indicate very high disease activity. Changes in scores from baseline to post-intervention are evaluated.
Baseline (pre-intervention) and post-intervention (12 weeks)
Change in Patient Global Assessment Using the Visual Analog Scale (VAS)
Ramy czasowe: Baseline (pre-intervention) and post-intervention (12 weeks)

Patient Global Assessment is measured using a Visual Analog Scale (VAS), reflecting the patient's overall perception of disease activity. Scores range from 0 to 10, with higher scores indicating greater perceived disease activity. Changes in scores from baseline to post-intervention are evaluated.
Baseline (pre-intervention) and post-intervention (12 weeks)
Change in C-Reactive Protein (CRP) Levels
Ramy czasowe: Baseline (pre-intervention) and post-intervention (12 weeks)

C-reactive protein (CRP) is an inflammatory marker used to assess systemic inflammation. Serum CRP levels are measured in milligrams per liter (mg/L), with higher values indicating greater systemic inflammation. Changes in CRP levels from baseline to post-intervention are evaluated.
Baseline (pre-intervention) and post-intervention (12 weeks)
Change in Erythrocyte Sedimentation Rate (ESR)
Ramy czasowe: Baseline (pre-intervention) and post-intervention (12 weeks)

Erythrocyte sedimentation rate (ESR) is an inflammatory marker used to assess systemic inflammation. ESR is measured in millimeters per hour (mm/h), with higher values generally indicating greater inflammatory activity. Changes in ESR from baseline to post-intervention are evaluated.
Baseline (pre-intervention) and post-intervention (12 weeks)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

31 października 2025

Zakończenie podstawowe (Szacowany)

18 listopada 2026

Ukończenie studiów (Szacowany)

18 listopada 2026

Daty rejestracji na studia

Pierwszy przesłany

2 listopada 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 listopada 2026

Pierwszy wysłany (Rzeczywisty)

6 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 listopada 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 3163/ 30.09.2025

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data (IPD) will not be shared, as no data-sharing plan was specified in the study protocol or informed consent process.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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