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Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis

2026年11月2日 更新者: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.

調査の概要

状態

積極的、募集していない

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

48

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~65年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ: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.

実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Madrid Sonographic Enthesitis Index (MASEI) Score
時間枠: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
時間枠: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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Achilles Tendon Stiffness Assessed by Shear-Wave Elastography
時間枠: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
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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)
時間枠: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)

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年10月31日

一次修了 (推定)

2026年11月18日

研究の完了 (推定)

2026年11月18日

試験登録日

最初に提出

2026年11月2日

QC基準を満たした最初の提出物

2026年11月2日

最初の投稿 (実際)

2026年11月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月6日

QC基準を満たした最後の更新が送信されました

2026年11月2日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 3163/ 30.09.2025

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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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