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Completed

NCT Number: NCT07039643

Pilates Method in Achilles Tendinopathy Rehabilitation

Achilles Tendinopathy (AT) is characterized by pain, swelling and dysfunction. Rehabilitation strategies focus on conservative treatment, with eccentric exercise being the main and most popular option. Patient education based on the biopsychosocial model is considered important for effective self-management, including modification of activities and loads and pain monitoring. Established exercise protocols are applied in rehabilitation, with eccentric, eccentric- concentric combinations and high-resistance exercises performed at a slow pace being the most popular. The Pilates method , which has gained popularity in recent years, focuses on core stabilization, motor control, correct posture through respiratory patterns during execution as well as flow and mindfulness and is applied to the rehabilitation of various musculoskeletal disorders. Although there is a research background in rehabilitation, the data for its application in AT are limited. The present study aims to investigate the integration of Pilates into clinical practice for AT.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physiotherapy Department, University of West Attica

Athens, Aigaleo, 12243, Greece

About this study

This study was designed as a pragmatic, parallel-group randomized controlled trial in individuals with Achilles tendinopathy. Participants were randomly allocated to either a Pilates-based rehabilitation group (intervention group) or an Alfredson eccentric loading group (control group) using a computer-generated random allocation sequence and sealed, opaque, sequentially numbered envelopes prepared by an independent researcher. Due to the nature of the interventions, participant and therapist blinding was not feasible. However, outcome assessment was performed by an assessor blinded to group allocation.

Different members of the research team were responsible for participant recruitment, randomization, intervention delivery, and outcome assessment in order to minimize potential bias and ensure allocation concealment. Participants were instructed not to disclose details of their intervention during outcome assessments. Adherence monitoring differed between groups according to the nature of the interventions. In the control group, participants received weekly follow-up communication and were encouraged to maintain adherence logs. In the Pilates group, adherence was monitored through supervised session attendance and rescheduling procedures when necessary.

Participants were recruited through referrals from healthcare professionals and public invitations for voluntary participation. Eligible participants were adults over 18 years of age with clinically diagnosed Achilles tendinopathy. Written informed consent was obtained prior to participation, and all participant data were pseudonymized using unique identification codes.

The intervention group followed an 8-week supervised Pilates-based rehabilitation program using Reformer equipment, with two 60-minute sessions per week and a 12-week follow-up assessment. The intervention incorporated progressive and individualized loading principles, motor control training, core stabilization, controlled movement execution, and functional progression according to symptom tolerance and participant performance.

The control group followed a 12-week modified Alfredson eccentric loading protocol. Participants performed a progressive home-based eccentric loading program involving exercises with the knee extended and flexed, adapted according to pain tolerance and symptom behavior. Weekly communication and monitoring were performed to support adherence and progression.

Outcome measures were collected at baseline and at 4, 8 and 12 weeks. Outcome assessment included patient-reported and functional measures evaluating pain, symptoms, kinesiophobia and functional performance in accordance with contemporary recommendations for Achilles tendinopathy assessment and the International Scientific Tendinopathy Symposium Consensus ICON/COS-AT framework.

An a priori sample size calculation using repeated measures ANOVA indicated that 128 participants would be required for adequate statistical power. Due to the pragmatic clinical design and recruitment feasibility, 49 participants were randomized and 45 completed the study. Statistical analysis was performed using repeated measures ANOVA to evaluate the effects of time, intervention group and time-by-group interaction across the assessment points. The study was designed primarily to evaluate feasibility, adherence, safety, acceptability and preliminary clinical response rather than to establish superiority between interventions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women over 18 years of age with clinically diagnosed Achilles tendinopathy.
  • Ability to understand the study procedures and provide written informed consent.
  • Sufficient knowledge of the Greek language to complete the assessment procedures and questionnaires.

Exclusion criteria

  • Previous surgery involving the Achilles Tendon or ankle region
  • History of malignancy, systemic disease, neurological disorder
  • Chronic corticosteroid use or corticosteroid injection in the affected tendon region within the previous 4 weeks.
  • Participation in another exercise rehabilitation or conservative treatment program for Achilles tendinopathy within the previous 4 weeks.
  • Any condition limiting safe participation in an exercise-based rehabilitation program.

Treatment and study plan

pilates exercise

Other

This study investigates a Pilates-based rehabilitation program for individuals with Achilles tendinopathy (AT). Although eccentric loading protocols remain the most commonly applied conservative treatment approach, some individuals demonstrate persistent symptoms, limited adherence, or difficulty tolerating high-load exercise programs. The Pilates method incorporates principles of core stabilization, motor control, movement quality, postural alignment, and progressive functional loading, potentially offering an alternative rehabilitation approach for individuals with AT. The present trial aims to evaluate the feasibility, adherence, safety, and preliminary clinical response of a Pilates-based intervention in relation to pain, function, kinesiophobia, and functional performance.

Alfredson protocol

Other

This study compares Alfredson eccentric loading protocol, which is one of the most commonly applied rehabilitation approaches for Achilles tendinopathy, with an alternative exercise-based rehabilitation program incorporating Pilates principles and progressive functional loading.

Primary outcomes

  1. TENDINS-A

    Time frame: Data collection will take place at 4 time points 0,4,8,12 weeks.

    TENDINS - A is a new, valid and reliable outcome measure that assesses pain, symptoms and physical activity. It exhibits adequate content validity and is considered the most representative tool for quantifying the effectiveness of interventions in Achilles tendon rehabilitation . tendinopathy ( Murphy and al ., 2024). The study on cross-cultural adaptation-translation and validity-reliability in the Greek language received approval from the Hellenic National Institute of Language and Culture with protocol number 102962/05-11-2024 . The results of the study were used to determine the characteristics of the main study sample.

Secondary outcomes

  1. Single- leg heel -rise test

    Time frame: Data collection will take place at 4 time points 0,4,8,12 weeks.

    The heel rise test records the number of repetitions until pain or fatigue occurs, while its effectiveness in assessing functional recovery has been documented with the maximum strength of recommendation (A) ( Silbernagel and al ., 2020).

  2. Tampa Scale for Kinesiophobia ( TSK)

    Time frame: Data collection will take place at 4 time points 0,4,8,12 weeks.

    Fear of movement and physical activity will be assessed with the Greek version of the Tampa scale. Scale for Kinesiophobia ( Georgoudis) and al ., 2005; Miller and al ., 1991). The TSK is a valid and reliable self-assessment tool that includes two subscales : activity avoidance and bodily focus-perception.

    The total score ranges from 17 to 68, where 17 indicates no kinesiophobia and 68 indicates severe kinesiophobia . A score > 37 indicates the presence of kinesiophobia .

  3. VAS scale

    Time frame: Data collection will take place at 4 time points 0,4,8,12 weeks.

    Visual Analogue Scale for Pain describes pain from 0 to 10. O dercribes a condition free of pain while 10 derscribes most pain.

Sponsors and collaborators

Lead sponsor

University of West Attica

Other

Registry information

Official study title

The Pilates Method in the Rehabilitation of Achilles Tendinopathy - A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 26, 2025
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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