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

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

September 13, 2022

Completed
2.8 years 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
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

June 26, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

June 17, 2025

Last Update Submit

June 17, 2025

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 seconds, 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 novel Pilates-based rehabilitation program for Achilles tendinopathy (AT). While eccentric loading is the standard treatment, many patients experience persistent symptoms or poor adherence. Pilates emphasizes core stability, neuromuscular control, and functional movement, offering a holistic approach that addresses kinetic chain dysfunction and movement impairments often overlooked in standard protocols. This trial will assess the feasibility and effectiveness of Pilates in improving pain, function, and movement quality in adults with AT. To our knowledge, this is the first clinical trial to evaluate Pilates as a targeted intervention for AT.

Group A: Pilates Group

At our knowledge this is the first study that will compare the most popular protocol in Achilles Tendinopathy to an alternative exercise method

Group B: Alfredson Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women within the age range of 18-40 years with diagnosed Achilles Tendinopathy.
  • Ability to provide consent and good knowledge of the Greek language

You may not qualify if:

  • Previous surgery in Achilles Tendon
  • Previous surgery in foot
  • Previous history of cancer, systemic diseases or autoimmune in the acute phase of symptoms
  • Previous use of medication or injections for the AT for the last 4 weeks
  • Previous long-term use of cortisone
  • Participation in a physical or other conservative therapy program for the last 4 weeks

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.

    PMID: 39297289BACKGROUND
  • 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.

    PMID: 37628466BACKGROUND
  • 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.

    PMID: 37615161BACKGROUND
  • 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.

    PMID: 37536026BACKGROUND
  • 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.

    PMID: 36274038BACKGROUND
  • 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.

    PMID: 34187784BACKGROUND

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
DOUBLE
Who Masked
INVESTIGATOR, 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
PT, MSc, PhD(c), Physiotherapy Department of the University of West Attica

Study Record Dates

First Submitted

June 17, 2025

First Posted

June 26, 2025

Study Start

September 13, 2022

Primary Completion

September 30, 2025

Study Completion

December 30, 2025

Last Updated

June 26, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

Only upon agreement by the authors that there will be no further changes and/ or analysis, results of the study will be published and shared. No patient data will be shared to be compliant with the latest GDPR code.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
6 months after publication date and only upon agreement by the authors that there will be no further changes and/or analysis may data be shared.
Access Criteria
It is to the authors discretion to share study data to other researchers.

Locations