- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Istanbul, Tyrkiet (Türkiye)
- Sisli Hamidiye Etfal Training and Research Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv 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. |
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. |
|
Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Madrid Sonographic Enthesitis Index (MASEI) Score
Tidsramme: 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
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Achilles Tendon Stiffness Assessed by Shear-Wave Elastography
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
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Change in Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS-CRP)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 3163/ 30.09.2025
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Individual participant data (IPD) will not be shared, as no data-sharing plan was specified in the study protocol or informed consent process.
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