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临床试验/NCT04824807
NCT04824807已完成不适用

The Comparison of the Effects of Clinical Pilates and Yoga Training in Women With Lymphedema After Breast Cancer

Eastern Mediterranean University2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年10月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
2
主要终点
upper extremity lymphedema

研究概览

简要总结

The aim of our study is to compare the effects of clinical Pilates and yoga training on lymphedema, upper limb muscle strength, proprioception, functions and quality of life in women with lymphedema after breast cancer.

详细描述

A total of 60 post breast cancer lymphedema individuals will be included in our study. The study will be performed in individuals who live in T.R.N.C and who develop mild, moderate or severe lymphedema after breast cancer in the 35-70 age range.

A randomized controlled trial design with three groups were used; 1) A Hatha yoga intervention group, 2) Clinical Pilates intervention group, 3) Control group.

Individuals in the intervention groups will be given 24 sessions of yoga or Clinical Pilates training 3 times a week for 8 weeks. Control group will not receive any treatment. During the training, and control group individuals will be asked to wear compression stockings during the 8 weeks and an educational booklet will be given to the each group.

The yoga classes included a progression of low-impact, modified poses, stretching and isometric exercises focused on the shoulders, arms, and chest, and meditation. Breathing and poses to drain the lymphatic system were incorporated throughout the yoga practice to assist with lymphatic flow. Before starting the Clinical Pilates exercise program, the patients will be trained on Pilates exercises and postures. During training, the patients will be taught how to create lumbopelvic stability (core stabilization), which is the basis for Pilates exercises, and spinal stabilization and appropriate posture techniques.

As a result of the research, the data will be analyzed to determine which treatment method is more effective in lymphedematous individuals.

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 (Participant)

入排标准

年龄范围
35 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Breast cancer survivors,
  • who are between the ages of 35-70,
  • who have unilateral mild, moderate or severe
  • lymphedema in the upper extremities after breast cancer treatment,
  • who have taken any of the Lymphedema treatment methods at least 6 months ago will be included.

排除标准

  • Presence of metastatic breast cancer,
  • Currently receiving adjuvant therapy (chemotherapy, radiotherapy, hormone therapy),
  • Severe heart failure (Class III),
  • Infections in extremities (fungal, redness, temperature increase),
  • Severe pain in the axillary region (eg: axillary web syndrome,
  • reflex sympathetic dystrophy, neuropathy),
  • Persons participating in a regular exercise program in the last 6 months will be excluded from the study.

结局指标

主要结局

upper extremity lymphedema

时间窗: eight weeks

Bilateral arm volume was measured with the upper extremity volumetric cup.Participants submerged their arm and hand into a water-filled column up to their axilla, and the volume of displaced water was recorded. Due to differences in volumetric measurement between both arms, it will be recorded.

次要结局

  • upper extremity muscle strength(eight weeks)
  • upper extremity proprioception(eight weeks)
  • upper extremity muscle endurance(eight weeks)
  • upper extremity functions(eight weeks)
  • Quality of Life Questionnaire(eight weeks)

研究者

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

Ferdiye Zabit

MSc physiotherapist

Eastern Mediterranean University

研究点 (2)

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