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临床试验/NCT05650372
NCT05650372已完成不适用

Comparison Of The Efficiency Of High Intensity And Low Intensity Resistive Exercises In Patient With Upper Extremity Lymphedema

Biruni University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
2
主要终点
Arm circumference measurement

研究概览

简要总结

Lymphedema results from impaired lymphatic transport with increased limb volume. The results of systematic reviews indicate that breast cancer survivors can perform resistance exercise training at high-enough intensities to elicit strength gains without triggering changes to lymphedema status. There is strong evidence indicating that ret produces significant gains in muscular strength without provoking breast cancer-related lymphedema. On the one hand, the literature studies say future exercise programs will have to be evaluated in detail regarding intensity, volume, duration, frequency, and exercised muscle group. The purpose of this study is to examine the impact of upper body resistance exercise on the arm circumference, grip strength, pain, musculoskeletal disorders of the upper limbs, self-reported lymphedema symptoms, pinch strength, lymphedema functioning, disability, and health questionnaire/lymph-ıcf patient with upper extremity lymphedema and to compare these effects between resistance exercise involving high and low loads (heavier vs lighter weights).

详细描述

Lymphedema results from impaired lymphatic transport with increased limb volume.

Lymphedema is divided into primary and secondary forms. Secondary lymphedema is likely to occur after the surgical removal of lymph nodes or in conjunction with radiotherapy. Secondary lymphedema is generally described as arm swelling and dysfunction. It is defined as an increase in arm circumference by more than 2 cm or as an accumulation of excessive protein-rich liquid in a part of the body where lymphatic vessels have been damaged. Erysipelas (cellulitis) is the main complication, but psychological or functional discomfort may occur throughout the course of lymphedema. The associated swelling may range from mild to disabling and is associated with feelings of distress, heaviness, and weakness in the arm, pain, and an increased risk for infection. These symptoms further impair the functional and self-care abilities of the individuals, causing significant psychological distress and reduced quality of life. Upper-limb lymphedema secondary to breast cancer treatment is the most frequent. Lymphedema management is based on complete decongestive physiotherapy (multilayer low-stretch bandage, manual lymph drainage, skincare, and exercises). The American college of sports medicine (ACSM) roundtable on exercise guidelines for cancer survivors describes that exercise during and after cancer treatment is safe and can help patients improve their physical capacity and quality of life. The ACSM guidelines indicate specific exercise programs oriented towards impairments associated with disease and medical treatment. Strength exercise does not have any adverse effects on an existing to; instead, it has beneficial effects such as improvement of strength and lower exacerbation rates. For breast cancer survivors who develop lymphedema, resistance exercise has been demonstrated to improve symptom severity, strength, endurance, and mobility of the affected limb, without exacerbating lymphedema. Recent evidence indicates that resistance exercise training can be an effective management strategy for breast cancer-related lymphedema by improving functional capacity and lymph flow through the pumping effect stimulated by muscular contraction. The results of systematic reviews indicate that breast cancer survivors can perform resistance exercise training at high-enough intensities to elicit strength gains without triggering changes to lymphedema status. There is strong evidence indicating that ret produces significant improvements in muscular strength without provoking breast cancer-related lymphedema. On the one hand, the literature studies say future exercise programs will have to be evaluated in detail regarding intensity, volume, duration, frequency, and exercised muscle group. The purpose of this study is examine the impact of upper body resistance exercise on the arm circumference, grip strength, pain, musculoskeletal disorders of the upper limbs, self-reported lymphedema symptoms, pinch strength, lymphedema functioning, disability, and health questionnaire/lymph-ıcf patient with upper extremity lymphedema and to compare these effects between resistance exercise involving high and low loads (heavier vs lighter weights).

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)

盲法说明

The assessor will be blind to the randomization and the investigator will be blind to the outcomes

入排标准

年龄范围
35 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Having been diagnosed with lymphedema of the upper extremity at least 6 months ago by the physician
  • Having stage 2 lymphedema
  • Having a circumference difference of 2-8 cm at any reference point between the affected extremity and the healthy extremity
  • Being between the ages of 35-60
  • Volunteer to participate
  • Not receiving lymphedema treatment in the last 6 months

排除标准

  • Having stage 1 or 3 lymphedema
  • Have a greater than 8 cm less than 2 cm circumference difference any reference point between the affected extremity and the healthy extremity
  • Papilloma, lymphedema or elephanthiasis with hyperkeratosis
  • Have acute inflammatory diseases

结局指标

主要结局

Arm circumference measurement

时间窗: 1 month

Bilateral arm circumference will be measured using a measuring tape at six reference points: the metacarpophalangeal joint, wrist joint, 10 and 15 cm distal to the lateral epicondyle, and 10 and 15 cm proximal to the lateral epicondyle.

次要结局

  • Lymphedema Symptom Severity Scale(1 month)
  • Pinch Strength Test(1 month)
  • Measure of grip strength(1 month)
  • The disabilities of the arm, shoulder and hand (DASH) questionnaire(1 month)
  • Evaluation of pain (McGill Pain Questionnaire)(1 month)
  • Lymphedema Life Impact Scale(1 month)
  • Lymphedema Functioning, Disability and Health Questionnaire(1 month)

研究者

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

Buket AKINCI

Assoc. Prof.

Biruni University

研究点 (2)

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