ClinicalTrials.gg
RecruitingNCT07497217ATORUpdated Apr 2, 2026

Change in ATOR Screening Test Scores Over 12 Weeks

An interventional study of Alfredson Exercise Program + Health Education + Analytical Stretching and Alfredson Exercise Program + Health Education in Achilles Tendinopathy (AT), sponsored by Universidad de Zaragoza. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-02.

Sponsored by Universidad de Zaragoza · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Feb 2026; still recruiting 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 43 studies in Tendinopathy with a site in Spain — 10 open to participants now, 10 under way, none of them phase 3. Tendinopathy · Spain.

Planned enrollment
26th of 40
40 · median 59
Started
2026
with 5 others
No phase
36 of 43
9 open now
Registered
39th of 43
by date
Lead sponsor
3 of 43
Universidad de Zaragoza

Among the 43 studies in Tendinopathy with a site in Spain, this one is the 26th largest by planned enrollment of the 40 interventional ones that give a count, is one of 6 that started in 2026, is one of 36 with no phase, and was the 39th registered.

Tendinopathy

397 studies on the registry are indexed under Tendinopathy; 77 are open to participants now.

Browse Tendinopathy studies →

Open to participants now

10 of the 43 studies in Tendinopathy with a site in Spain are open now. Recruiting first, the newest first:

4 more — sign in →

All 10 open studies →

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

Who these studies take

Of the 47 Tendinopathy studies recruiting now, 16 (34%) set no upper age limit and 24 (51%) stop at 75 or younger; 1 take children under 18; 7 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

Achilles tendinopathy (AT) is one of the most common overuse injuries in runners, with an estimated incidence ranging from 0.6% to 18.5% of all running-related injuries, reaching up to 52% in elite runners. Its prevalence increases significantly from the fourth decade of life due to histological changes associated with aging, such as tissue degeneration, decreased vascularization, alterations in collagen structure, reduced recovery capacity, and increased tendon stiffness. The repetitive nature of running and the high proportion of the population practicing this sport make runners, especially those over 40 years old, a particularly vulnerable group.

The etiology of AT is multifactorial and includes biomechanical, physiological, and contextual factors. Major risk factors include sudden increases in load, planning errors in training, biomechanical alterations, overweight, metabolic comorbidities such as diabetes or dyslipidemia, and exposure to certain medications, especially corticosteroids and fluoroquinolones. In middle-aged individuals, the combination of intrinsic and extrinsic factors along with structural tendon changes explains both the higher prevalence and the worse prognosis observed in this population.

Physiotherapy is one of the preferred treatments for AT, with therapeutic exercise-particularly the Alfredson protocol-being the intervention with the strongest scientific support. Despite its efficacy, between 25% and 45% of patients do not achieve full recovery, suggesting the influence of clinical, personal, and contextual factors not always considered in studies. Additionally, there is high variability in return-to-sport times, which has led to the development of specific programs for runners over 40.

In the Aragón community, there are no studies describing the extent of AT in senior runners nor systematically analyzing their clinical characteristics, comorbidities, referral patterns, or healthcare service use. This lack of information hampers evidence-based decision-making and the planning of preventive and therapeutic strategies in physiotherapy. This study aims to fill this gap by providing contextualized information to improve clinical practice, healthcare pathways, and physiotherapeutic guidelines.

The hypothesis of the study is that an assessment system using screening has validity for detecting clinical changes in senior runners with Achilles tendon pain. The main objective is to determine the validity of this screening compared to other clinical measures after applying a physiotherapy protocol.

A clinimetric validity design is proposed. The sample will include 40 runners over 40 years old, belonging to sports clubs, who train at least three days a week and have participated in at least five 10 km races in the past year. Participants will be recruited through running clubs and social media, and randomly assigned to two groups of 20 people each. Exclusion criteria include recent invasive treatments, use of fluoroquinolones in the last year, autoimmune diseases, or difficulties understanding questionnaires.

Data collected will include sociodemographic, anthropometric, sports activity, and clinical variables through validated scales (VISA-A, NPRS, IPAQ, and SMFA), as well as ultrasound characteristics of the tendon, ankle mobility, passive calcaneal mobility, and functional screening tests based on active movements and jumps.

The procedure involves initial measurements, random assignment to control or experimental groups, and a 12-week home self-treatment program. Both groups will perform the Alfredson exercise protocol and receive health education; the experimental group will add analytical stretching of the posterior chain following OMT methodology.

Statistical analysis will assess intergroup and intragroup differences using repeated measures ANOVA, analyze time-group interactions, and include sensitivity-to-change statistics such as effect size, minimal clinically important difference, and reliable change index.

A gender perspective will be incorporated, limiting the representation of one sex to a maximum of 70% of the sample and analyzing results separately by gender. Main limitations include the small sample size, short follow-up duration, and limited control over adherence to home treatment.

Finally, the study clearly defines internal and external validity and clarifies the use of the term screening as a functional discrimination tool within a homogeneous and clinically defined population, without asserting generalization to the broader population.

03

Conditions studied

  • Achilles Tendinopathy (AT)

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
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

  • Senior runners
  • They belong to a running club
  • That they have run at least 5 10-kilometer races in the past year
  • They should work out at least three times a week

Exclusion criteria

Exclusion Criteria:

  • Runners who have received physiotherapy treatment involving invasive techniques in the last 3 months
  • Runners who have received pharmacological treatment with fluoroquinolones (levofloxacin, ciprofloxacin) in the last year
  • Runners with diseases
  • Individuals with limited comprehension who may be unable to answer surveys
Terms in these criteria, in plain language(1)

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.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Experimental group: Alfredson exercises + health education + analytical stretching

    Program 1

    Other: Alfredson Exercise Program + Health Education + Analytical Stretching

  • Experimental
    Control group: Alfredson exercises + health education

    Program 2

    Other: Alfredson Exercise Program + Health Education

Interventions

  • OtherAlfredson Exercise Program + Health Education + Analytical Stretching

    Compared with the other intervention in this study, this approach adds analytical stretching and self-stretching of the gastrocnemius and soleus muscles, following the Kaltenborn-Evjenth method, in patients with Achilles tendinopathy

  • OtherAlfredson Exercise Program + Health Education

    Compared with the other intervention in this study, this approach does not include analytical stretching and self-stretching of the gastrocnemius and soleus muscles based on the Kaltenborn-Evjenth method in patients with Achilles tendinopathy

06

What researchers measure

Primary outcomes

  1. Mean change from baseline in total screening score (sum of five test scores) at 12 weeks

    The total movement screening score is calculated as the sum of five movement-based tests assessing \[e.g., mobility, stability, and functional movement\]. Each test is scored independently according to predefined criteria, and the total score represents overall movement performance. Change from baseline is defined as the difference between baseline and 12-week values.

    Time frame: From enrollment to the end of treatment at 12 weeks

Secondary outcomes

  1. Mean change from baseline in Achilles tendon thickness measured by ultrasound at two anatomical points at 12 weeks

    Achilles tendon thickness will be measured using ultrasound at two predefined anatomical points along the tendon. Measurements will be recorded in millimeters. Change from baseline is defined as the difference between baseline and 12-week values.

    Time frame: From enrollment to the end of treatment at 12 weeks

  2. Mean change from baseline in VISA-A score at 12 weeks

    The Victorian Institute of Sport Assessment-Achilles (VISA-A) questionnaire will be used to assess symptoms and function in patients with Achilles tendinopathy. The VISA-A score ranges from 0 to 100, with higher scores indicating better function and fewer symptoms. Change from baseline is defined as the difference between baseline and 12-week values.

    Time frame: From enrollment to the end of treatment at 12 weeks

Other outcomes

  1. Mean change from baseline in pain intensity measured by Numeric Pain Rating Scale (NPRS) at 12 weeks

    Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Change from baseline is defined as the difference between baseline and 12-week values.

    Time frame: From enrollment to the end of treatment at 12 weeks

  2. Mean change from baseline in physical activity level measured by the International Physical Activity Questionnaire (IPAQ) at 12 weeks

    Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ). Results will be expressed according to standard scoring protocols (e.g., MET-minutes/week). Change from baseline is defined as the difference between baseline and 12-week values.

    Time frame: From enrollment to the end of treatment at 12 weeks

  3. Mean change from baseline in functional status measured by the Short Musculoskeletal Function Assessment (SMFA) at 12 weeks

    Functional status will be assessed using the Short Musculoskeletal Function Assessment (SMFA) questionnaire. Scores will be calculated according to standard scoring procedures, with higher scores indicating worse function. Change from baseline is defined as the difference between baseline and 12-week values.

    Time frame: From enrollment to the end of treatment at 12 weeks

  4. Mean change from baseline in ankle dorsiflexion range of motion at 12 weeks

    Ankle dorsiflexion range of motion will be measured in degrees using a goniometer. Passive ankle mobility will be assessed through standardized physiotherapy examination procedures. Change from baseline is defined as the difference between baseline and 12-week values.

    Time frame: From enrollment to the end of treatment at 12 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — This study collects clinical and functional information from patients with Achilles tendinopathy, including demographic data, pain measures, functional tests, and patient-reported outcomes. However, the informed consent for this trial does not include permission for secondary use or external sharing of de-identified individual data. In addition, the purpose of the study is to evaluate two specific physiotherapy-based intervention programs, and the dataset is not intended for broader data-sharing or secondary analyses outside the primary research group.

No publications or documents are linked to this record.

09

Timeline

Tracking 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 Feb 2026 (actual). Primary completion is estimated for May 2026, 3 months after the start.

Of 174 non-industry interventional studies with no phase under Tendinopathy, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 3 months is below that.

Counting every sponsor, half of 183 studies reached it within 20 months; a quarter within 7 and three quarters within 37.

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

Registered
Feb 7, 2026
First posted
Mar 27, 2026
StartActual
Feb 16, 2026
Primary completionEst.
May 18, 2026
CompletionEst.
Jul 18, 2026
Last update
Apr 2, 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.
No changes since tracking began. The registry record was last updated on Apr 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07497217
Responsible party
Sergio Hijazo Larrosa (PhD, Universidad de Zaragoza) — Principal investigator
First posted
Mar 27, 2026
Start date
Feb 16, 2026
Primary completion
May 18, 2026 (estimated)
Completion
Jul 18, 2026 (estimated)
Last update
Apr 2, 2026

Study contacts

Sergio Hijazo, Phd
Contact
shijazo@unizar.es
+34 673 74 40 10

Oversight

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

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