ClinicalTrials.gg
Active, not recruitingNCT07923006Updated Nov 6, 2026

Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis

An interventional study of Walking program and Resistance Exercise Program in Spondyloarthritis (SpA) and Axial Spondylarthritis (axSpA), sponsored by Sisli Hamidiye Etfal Training and Research Hospital. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Sisli Hamidiye Etfal Training and Research Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Oct 2025, registered Nov 2026).
Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 11 studies in Spondylarthritis with a site in Turkey — 3 open to participants now, 4 under way, none of them phase 3. Spondylarthritis · Turkey.

Started
2025
with 1 other
No phase
3 of 11
none open now
Registered
11th of 11
by date
Lead sponsor
1 of 11
Sisli Hamidiye Etfal Training and Research Hospital

Among the 11 studies in Spondylarthritis with a site in Turkey, this one is one of 2 that started in 2025, is one of 3 with no phase, and was the 11th registered.

Spondylarthritis

202 studies on the registry are indexed under Spondylarthritis; 51 are open to participants now.

Browse Spondylarthritis studies →

Open to participants now

3 of the 11 studies in Spondylarthritis with a site in Turkey are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 37 Spondylarthritis studies recruiting now, 20 (54%) set no upper age limit and 9 (24%) stop at 75 or younger; 7 take children under 18; 8 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 11 studies in Spondylarthritis with a site in Turkey, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Spondyloarthritis (SpA)
  • Axial Spondylarthritis (axSpA)

Browse trials for

Keywords

  • Spondyloarthritis
  • Enthesitis
  • Resistance Exercise
  • Ultrasonography
  • Shear-Wave Elastography
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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 .
  • Orthopedic or cardiopulmonary conditions that may contraindicate exercise.
  • Neurological disorders causing motor dysfunction.
  • 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Active comparator
    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.

    Other: Walking program

  • Experimental
    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.

    Other: Walking program · Other: Resistance Exercise Program

Interventions

  • OtherWalking 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.

  • OtherResistance 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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: Baseline (pre-intervention) and post-intervention (12 weeks)

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline (pre-intervention) and post-intervention (12 weeks)

07

Study locations

1 site
08

References and documents

Individual participant data

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

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Nov 2026, 12 months after the start.

Of 44 non-industry interventional studies with no phase under Spondylarthritis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 77. This study's planned 12 months is below that.

Counting every sponsor, half of 46 studies reached it within 30 months; a quarter within 16 and three quarters within 77.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 2, 2026
First posted
Nov 6, 2026
StartActual
Oct 31, 2025
Primary completionEst.
Nov 18, 2026
CompletionEst.
Nov 18, 2026
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07923006
Responsible party
Gamze TAŞDELEN (Physical Medicine and Rehabilitation Resident, Sisli Hamidiye Etfal Training and Research Hospital) — Principal investigator
First posted
Nov 6, 2026
Start date
Oct 31, 2025
Primary completion
Nov 18, 2026 (estimated)
Completion
Nov 18, 2026 (estimated)
Last update
Nov 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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