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临床试验/NCT07070791
NCT07070791招募中不适用

Investigation of the Effect of Combined Upper Extremity Resistance and Aerobic Exercise Training on Arm Exercise Capacity, Peripheral Muscle Strength and Arm Functionality in Patients With Breast Cancer

Hacettepe University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
6 minute Pegboard and Ring Test - 6PBRT

研究概览

简要总结

According to updated data from the International Agency for Research on Cancer (IARC) for 2022, breast cancer in women is responsible for one in four cancer cases and one in six cancer deaths worldwide and is the second leading cause of global cancer incidence, accounting for 11.6% of all cancer cases, and the fourth leading cause of cancer deaths worldwide, accounting for 6.9% of all cancer deaths. During or after breast cancer treatments, there is exposure to a variety of direct (local/regional treatment, systemic treatment and supportive care) and indirect factors (modifiable and non-modifiable risk factors) that may have adverse effects on treatment-related haematological, cardiovascular, pulmonary and musculoskeletal components. Upper limb dysfunction and lymphoedema have been reported to be two of the most common side effects affecting the quality of life of breast cancer patients after breast cancer treatments. The elastic resistance band, which is widely used in strength training, has the advantage of being applied to various classes because it provides resistance angles in various postures and has a low risk of injury. However, few studies have been conducted on elastic resistance band application in patients with breast cancer. At the same time, evidence on the effectiveness of upper extremity aerobic exercise training in patients with breast cancer is limited. Therefore, this study aimed to investigate the effects of upper extremity aerobic exercise training combined with progressive resistance training and upper extremity aerobic exercise training alone on upper extremity exercise capacity, upper extremity functionality, sarcopenia, frailty, quality of life and lymphedema in patients with breast cancer.

详细描述

According to updated data from the International Agency for Research on Cancer (IARC) for 2022, breast cancer in women is responsible for one in every four cancer cases and one in every six cancer deaths worldwide and is the second leading cause of global cancer incidence, accounting for 11.6% of all cancer cases, and the fourth leading cause of death from cancer worldwide, accounting for 6.9% of all cancer deaths. The prognosis of breast cancer has improved significantly with comprehensive screening programmes, early diagnosis and innovative systematic treatments, with a 5-year survival rate of 90% and a 10-year survival rate of approximately 80%. On the other hand, with increasing survival rates, various strategies are needed for the management of short- and long-term sequelae related to breast cancer treatments, especially considering quality of life. During or after breast cancer treatments, patients are exposed to various direct (local/regional treatment, systemic treatment and supportive care) and indirect factors (modifiable and non-modifiable risk factors) that may have adverse effects on haematological, cardiovascular, pulmonary and musculoskeletal components. Upper limb dysfunction and lymphoedema have been reported to be two of the most common side effects affecting the quality of life of breast cancer patients after breast cancer treatments. Up to 70% of breast cancer patients experience pain, discomfort and/or reduced physical function in the affected shoulder, arm and hand, depending on the type of surgery, rehabilitation programmes or assessment tools and other factors. The percentage of women experiencing lymphoedema after breast cancer surgery is very heterogeneous and varies between studies from 4% to over 60%. As a result of upper extremity dysfunction, decreased ability of individuals to perform activities of daily living is frequently observed. This is a major concern in terms of clinical and public health. In addition, the increase in arm volume and lymphoedema represent a significant threat to life. The American Cancer Society and the National Cancer Institute recommend exercise led by an expert as a safe and feasible method to reduce the risk of developing lymphoedema. Furthermore, many studies have observed that resistance training and concurrent training are beneficial in preventing short- and long-term upper extremity disorders. Resistance training and other forms of physical activity are among the most effective treatments to regain shoulder joint mobility, reduce pain and discomfort, and improve quality of life in breast cancer patients. In addition, some studies suggest that resistance exercise may reduce lymphoedema. However, there is still a lack of information for patients due to medical recommendations to restrict the affected arm and a lack of implementation of these recommendations in clinical practice, leading to greater fear of using the affected arm, lower physical activity, lower muscle strength and greater perceived weakness.

The elastic resistance band, which is widely used in strength training, has the advantage of being applied to various classes because it provides resistance angles in various postures and has a low risk of injury. However, few studies have been conducted on elastic resistance band application in patients with breast cancer. At the same time, evidence on the effectiveness of upper extremity aerobic exercise training in patients with breast cancer is limited. Therefore, this study aimed to investigate the effects of upper extremity aerobic exercise training combined with progressive resistance training and upper extremity aerobic exercise training alone on upper extremity exercise capacity, upper extremity functionality, sarcopenia, frailty, quality of life and lymphedema in patients with breast cancer.

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
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • To be between 18-80 years old,
  • Volunteering to participate in the research,
  • At least 15 months after breast cancer surgery,
  • No problems in reading and/or understanding the scales and being able to co-operate with the tests.
  • Physically inactive (60 minutes of structured exercise per week <).

排除标准

  • Presence of active infection,
  • Presence of bilateral breast cancer,
  • History of surgical, neurological or orthopaedic problems that may affect upper extremity functionality other than breast cancer surgery,
  • Having a neurological disease or other clinical diagnosis that may affect cognitive status,
  • Musculoskeletal and neurological disease that may affect exercise performance, symptomatic heart disease, previous lung surgery and malignant disease.
  • Presence of unstable hypertension or diabetes mellitus.

研究组 & 干预措施

Upper Extremity Progressive Resistance Training Combined with Aerobic Exercise Training

Experimental

Participants will receive a 12-week upper extremity aerobic exercise training program plus upper extremity progressive resistance exercise training.

干预措施: Upper Extremity Aerobic Exercise Training (Other)

Upper Extremity Progressive Resistance Training Combined with Aerobic Exercise Training

Experimental

Participants will receive a 12-week upper extremity aerobic exercise training program plus upper extremity progressive resistance exercise training.

干预措施: Upper Extremity Progressive Resistance Exercise Training (Other)

Upper Extremity Aerobic Exercise

Active Comparator

Participants will only receive a 12-week upper limb aerobic exercise training program.

干预措施: Upper Extremity Aerobic Exercise Training (Other)

结局指标

主要结局

6 minute Pegboard and Ring Test - 6PBRT

时间窗: One Year

Total number of rings inserted in six minutes

Maximal Arm Exercise Capacity

时间窗: One Year

VO2peak requirement during arm ergometry will be estimated using MET levels calculated at each power output based on gender at various body weights and will be displayed in ml/kg/min (1 MET = 3.5 ml/kg/min)

次要结局

  • Evaluation of Quality of Life(One Year)
  • Peripheral Muscle Strength(One Year)
  • Anthropometric Measurements(One Year)
  • Comorbidity Assessment(One Year)
  • Peripheral muscle strength assessment(One Year)
  • Evaluation of Upper Extremity Functionality(One Year)
  • Assessment of Sarcopenia(One Year)
  • Assessment of Frailty Status(One Year)
  • Lymphoedema Evaluation(One Year)

研究者

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

Ebru Calik

Professor

Hacettepe University

研究点 (2)

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