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Recruiting NCT07070791

Combined Upper Extremity Resistance and Aerobic Exercise Training in Patients With Breast Cancer

No phase Interventional Breast Cancer Upper Extremity Resistance Exercise Aerobic Exercise

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Upper Extremity Aerobic Exercise Training, Upper Extremity Progressive Resistance Exercise Training.
Who it may be relevant to
Registry conditions: Breast Cancer, Upper Extremity, Resistance Exercise, Aerobic Exercise. Basic parameters: 18 years — 80 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other Upper Extremity Aerobic Exercise Training
    12 weeks of upper extremity aerobic exercise training, 3 sessions per week, 25 minutes per session.
  • Other Upper Extremity Progressive Resistance Exercise Training
    Upper extremity progressive resistance training was gradually increased over 12 weeks using elastic resistance bands.

Primary outcome measures

  • 6 minute Pegboard and Ring Test - 6PBRT [Time frame: One Year]
  • Maximal Arm Exercise Capacity [Time frame: One Year]
Secondary outcome measures (9)
  • Evaluation of Quality of Life [Time frame: One Year]
  • Peripheral Muscle Strength [Time frame: One Year]
  • Anthropometric Measurements [Time frame: One Year]
  • Comorbidity Assessment [Time frame: One Year]
  • Peripheral muscle strength assessment [Time frame: One Year]
  • Evaluation of Upper Extremity Functionality [Time frame: One Year]
  • Assessment of Sarcopenia [Time frame: One Year]
  • Assessment of Frailty Status [Time frame: One Year]
  • Lymphoedema Evaluation [Time frame: One Year]

Eligibility criteria

Inclusion criteria

  • 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 <).

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Hcettepe University — Ankara

Identifiers

NCT: NCT07070791 · 2025/5-47

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗