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临床试验/NCT07448467
NCT07448467已完成不适用

Investigating the Effectiveness of Progressive Resistance Exercise Training in the Management of Lymphedema Developing After Breast Cancer Treatment: a Randomized Controlled Trial

Uskudar University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年3月6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
发起方
入组人数
50
试验地点
2
主要终点
Percentage of excess limb volume

研究概览

简要总结

This study aims to investigate the effect of progressive resistance exercise training on the clinical findings and functional outcomes of lymphedema in individuals who develop upper extremity lymphedema after breast cancer treatment (surgery, chemotherapy and/or radiotherapy).

详细描述

The study is designed as a randomized controlled trial. Fifty women who developed unilateral upper-limb lymphoedema following breast cancer treatment were randomly allocated in a 1:1 ratio to an exercise group or a control group.

Both groups received classic lymphoedema physiotherapy twice weekly for 12 weeks (24 sessions), comprising manual lymphatic drainage (30 minutes), multilayer short-stretch compression bandaging applied at the end of each session, simple lymphatic exercises (15 minutes), and structured skin-care education. Standard compression bandaging was used in both groups throughout the study period.

In addition, participants in the exercise group performed a home-based progressive resistance exercise programme for the upper limb twice weekly on non-consecutive days for 12 weeks. Each session lasted 40 to 45 minutes and comprised a 10-minute warm-up, a 20- to 25-minute resistance component and a 10-minute cool-down. The resistance component consisted of eight exercises performed bilaterally using Thera-Band elastic resistance: shoulder flexion, shoulder abduction, shoulder external rotation, elbow flexion, elbow extension, wrist flexion, wrist extension, and scapular retraction and protraction, in three sets of ten repetitions each. Exercise intensity was prescribed by band colour and monitored using the Borg CR10 scale (target 4 to 6), and resistance was progressed by one band colour every four weeks. All sessions were performed while wearing the compression bandaging already in place as part of standard care.

Adherence was monitored using a structured exercise log and telephone contact every 15 days. All participants were assessed at baseline and after 12 weeks by an outcome assessor blinded to group allocation.

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
30 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female, aged 30 to 60 years
  • Unilateral upper-limb lymphoedema following treatment for breast cancer (surgery, chemotherapy and/or radiotherapy), diagnosed clinically by a physician
  • Excess limb volume of at least 10% relative to the unaffected limb, calculated from bilateral circumferential measurements using the truncated cone formula
  • At least 3 months post-surgery
  • Able to tolerate compression bandaging or a compression garment

排除标准

  • Within the first 3 months after surgery
  • Requiring reinitiation of active cancer treatment during the study period

研究组 & 干预措施

exercise group

Experimental

Classic lymphoedema physiotherapy as in the control group, plus a home-based progressive resistance exercise programme for the upper limb, twice weekly for 12 weeks (24 sessions), using Thera-Band elastic resistance with band-colour progression every four weeks.

干预措施: exercise (Other)

control group

Active Comparator

Classic lymphoedema physiotherapy alone, twice weekly for 12 weeks (24 sessions): manual lymphatic drainage (30 min), multilayer short-stretch compression bandaging, simple lymphatic exercises (15 min) and skin-care education. No resistance exercise programme was prescribed.

干预措施: control (Other)

exercise group

Experimental

Classic lymphoedema physiotherapy as in the control group, plus a home-based progressive resistance exercise programme for the upper limb, twice weekly for 12 weeks (24 sessions), using Thera-Band elastic resistance with band-colour progression every four weeks.

干预措施: control (Other)

结局指标

主要结局

Percentage of excess limb volume

时间窗: Baseline and 12 weeks

Limb circumference measured with a flexible tape at 5 cm intervals from the ulnar styloid process to 40 cm proximally in both limbs. Segmental volumes calculated using the truncated cone formula and summed. Excess volume expressed as the percentage difference between the affected and unaffected limb relative to the unaffected limb volume. A lower value indicates less lymphoedema.

LYMphedema Quality of Life

时间窗: 14 weeks

The Lymphedema Quality of Life Questionnaire, a validated disease-specific QoL tool, was also administered at baseline and at day 28. Overall QoL is scored on a single item by the patient on a scale of 1-10.

Disabilities of the Arm, Shoulder and Hand

时间窗: 14 weeks

Validated outcome measure that asks an individual to self-report about the ability to perform certain upper limb activities. Questions are responded on a 5-point Likert scale.

次要结局

  • LYMphedema Quality of Life(Baseline and 12 weeks)
  • Disabilities of the Arm, Shoulder and Hand(Baseline and 12 weeks)

研究者

发起方
Uskudar University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Doç.Dr.Ömer Şevgin

Assoc.Prof.Dr.

Uskudar University

研究点 (2)

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