NCT07039643

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 19, 2025

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 26, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2026

Completed
Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

June 17, 2025

Last Update Submit

May 10, 2026

Conditions

Keywords

Achilles tendinopathyAchilles Tendon injuriesexerciseRehabilitationPilates exercisePilates methodPilates

Outcome Measures

Primary Outcomes (1)

  • TENDINS-A

    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.

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

Secondary Outcomes (3)

  • Single- leg heel -rise test

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

  • Tampa Scale for Kinesiophobia ( TSK)

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

  • VAS scale

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

Study Arms (2)

Group A: Pilates Group

EXPERIMENTAL

Group A will follow exercise sessions based on the Pilates method. The protocol will be determined and performed twice a week for 60 minutes, for 8 weeks with a 12 week follow-up. The Pilates will be performed on Reformer equipment and at the final stages jumboard will be added.

Other: Pilates exercise

Group B: Alfredson Group

ACTIVE COMPARATOR

Group B will follow the Alfredson Protocol at home with a diary. Instructions at the beginning will ensure the correct execution while there will be communication once a week to ensure the commitment and compliance. Participants will have to perform 3 sets of 15 repetitions of each exercise 7 days a week for 12 weeks.

Other: Alfredson protocol

Interventions

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.

Group A: Pilates Group

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.

Group B: Alfredson Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physiotherapy Department, University of West Attica

Athens, Aigaleo, 12243, Greece

Location

Related Publications (6)

  • Sivrika AP, Kypraios G, Lamnisos D, Georgoudis G, Stasinopoulos D. Pilates Dosage in Rehabilitation of Patients With Musculoskeletal Conditions: A Scoping Review. Sports Health. 2025 Jul;17(4):824-833. doi: 10.1177/19417381241278263. Epub 2024 Sep 19.

  • Sivrika AP, Papadamou E, Kypraios G, Lamnisos D, Georgoudis G, Stasinopoulos D. Comparability of the Effectiveness of Different Types of Exercise in the Treatment of Achilles Tendinopathy: A Systematic Review. Healthcare (Basel). 2023 Aug 11;11(16):2268. doi: 10.3390/healthcare11162268.

  • Murphy MC, Newsham-West R, Cook J, Chimenti RL, de Vos RJ, Maffulli N, Malliaras P, Mkumbuzi N, Purdam C, Vosseller JT, Rio EK. TENDINopathy Severity Assessment - Achilles (TENDINS-A): Development and Content Validity Assessment of a New Patient-Reported Outcome Measure for Achilles Tendinopathy. J Orthop Sports Phys Ther. 2024 Jan;54(1):70-85. doi: 10.2519/jospt.2023.11964.

  • Merry K, MacPherson M, Vis-Dunbar M, Whittaker JL, Gravare Silbernagel K, Scott A. Identifying characteristics of resistance-based therapeutic exercise interventions for Achilles tendinopathy: A scoping review. Phys Ther Sport. 2023 Sep;63:73-94. doi: 10.1016/j.ptsp.2023.06.002. Epub 2023 Jul 1.

  • Malliaras P. Physiotherapy management of Achilles tendinopathy. J Physiother. 2022 Oct;68(4):221-237. doi: 10.1016/j.jphys.2022.09.010. Epub 2022 Oct 21. No abstract available.

  • de Vos RJ, van der Vlist AC, Zwerver J, Meuffels DE, Smithuis F, van Ingen R, van der Giesen F, Visser E, Balemans A, Pols M, Veen N, den Ouden M, Weir A. Dutch multidisciplinary guideline on Achilles tendinopathy. Br J Sports Med. 2021 Oct;55(20):1125-1134. doi: 10.1136/bjsports-2020-103867. Epub 2021 Jun 29.

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • AIKATERINI P SIVRIKA, PhDc

    University of West Attica

    PRINCIPAL INVESTIGATOR
  • Dimitrios Stasinopoulos, PhD

    University of West Attica

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment. This is a randomised controlled trial with primary end point at 8 weeks for the intervention group and second primary point at 12 weeks while the end point for the control group will be at 12 weeks. Participants will be allocated randomly into two groups (intervention and control).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Department of Physiotherapy

Study Record Dates

First Submitted

June 17, 2025

First Posted

June 26, 2025

Study Start

May 19, 2025

Primary Completion

September 30, 2025

Study Completion

May 8, 2026

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to privacy and data protection restrictions.

Locations