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Spondyloarthritis (SpA)NCT07923006

Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis

A study testing Walking program and Resistance Exercise Program in people with Spondyloarthritis (SpA) and Axial Spondylarthritis (axSpA), run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Walking program and Resistance Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteTurkey (Türkiye)
Study dates
31 Oct 2025to 18 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Sisli Hamidiye Etfal Training and Research Hospital

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Walking program, Resistance Exercise Program
Keywords
Spondyloarthritis, Enthesitis, Resistance Exercise, Ultrasonography, Shear-Wave Elastography
Medical subject headings
Spondylarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Walking programOther

    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.

  • Resistance Exercise ProgramOther

    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.

Study groups in NCT07923006
Study groupRoleWhat they receive
Walking Control GroupActive comparatorParticipants 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.
Receives: Other: Walking program
Combined Walking and Resistance Exercise GroupExperimentalParticipants 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.
Receives: Other: Walking program; Other: Resistance Exercise Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Madrid Sonographic Enthesitis Index (MASEI) Score

    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.

    Measured: Baseline (pre-intervention) and post-intervention (12 weeks)

  2. Change in Glasgow Ultrasound Enthesitis Scoring System (GUESS) Score

    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.

    Measured: Baseline (pre-intervention) and post-intervention (12 weeks)

Secondary outcomes (12)
  1. Change in Achilles Tendon Stiffness Assessed by Shear-Wave Elastography

    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.

    Measured: Baseline (pre-intervention) and post-intervention (12 weeks)

  2. Change in Patellar Tendon Stiffness Assessed by Shear-Wave Elastography

    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.

    Measured: Baseline (pre-intervention) and post-intervention (12 weeks)

  3. Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)

    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.

    Measured: Baseline (pre-intervention) and post-intervention (12 weeks)

  4. Change in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index

    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.

    Measured: Baseline (pre-intervention) and post-intervention (12 weeks)

  5. Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score

    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.

    Measured: Baseline (pre-intervention) and post-intervention (12 weeks)

  6. Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score

    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.

    Measured: Baseline (pre-intervention) and post-intervention (12 weeks)

  7. Change in Ankylosing Spondylitis Quality of Life (ASQoL) Score

    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.

    Measured: Baseline (pre-intervention) and post-intervention (12 weeks)

  8. Change in Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS-CRP)

    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.

    Measured: Baseline (pre-intervention) and post-intervention (12 weeks)

  9. Change in Ankylosing Spondylitis Disease Activity Score Using Erythrocyte Sedimentation Rate (ASDAS-ESR)

    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.

    Measured: Baseline (pre-intervention) and post-intervention (12 weeks)

  10. Change in Patient Global Assessment Using the Visual Analog Scale (VAS)

    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.

    Measured: Baseline (pre-intervention) and post-intervention (12 weeks)

  11. Change in C-Reactive Protein (CRP) Levels

    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.

    Measured: Baseline (pre-intervention) and post-intervention (12 weeks)

  12. Change in Erythrocyte Sedimentation Rate (ESR)

    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.

    Measured: Baseline (pre-intervention) and post-intervention (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2026
  2. Study start31 Oct 2025
  3. Primary completion18 Nov 2026 (estimated)
  4. Study completion18 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants were randomly assigned to two parallel groups: an intervention group receiving resistance exercises in addition to a walking program and a control group following a walking program alone.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07923006
Sponsor's protocol ID
3163/ 30.09.2025
Status last verified
Oct 2026
First submitted
2 Nov 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared, as no data-sharing plan was specified in the study protocol or informed consent process.

Questions about this trial

What is this clinical trial studying?

A study testing Walking program and Resistance Exercise Program in people with Spondyloarthritis (SpA) and Axial Spondylarthritis (axSpA), run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Madrid Sonographic Enthesitis Index (MASEI) Score (time frame: Baseline (pre-intervention) and post-intervention (12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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