- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07923006
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Istanbul, Turchia (Türkiye)
- Sisli Hamidiye Etfal Training and Research Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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. |
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. |
|
Sperimentale: 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. |
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. 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Madrid Sonographic Enthesitis Index (MASEI) Score
Lasso di tempo: 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
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Achilles Tendon Stiffness Assessed by Shear-Wave Elastography
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 3163/ 30.09.2025
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Individual participant data (IPD) will not be shared, as no data-sharing plan was specified in the study protocol or informed consent process.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .