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临床试验/NCT07039643
NCT07039643已完成不适用

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

University of West Attica1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2025年5月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
1
主要终点
TENDINS-A

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Pilates exercise (Other)

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.

干预措施: Alfredson protocol (Other)

结局指标

主要结局

TENDINS-A

时间窗: 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.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

AIKATERINI SIVRIKA

Principal Investigator, Department of Physiotherapy

University of West Attica

研究点 (1)

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