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

NCT ID: NCT07070791

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-08

Study Completion Date

2026-07-01

Brief Summary

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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

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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.

Conditions

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Breast Cancer Upper Extremity Resistance Exercise Aerobic Exercise

Keywords

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breast cancer Upper Extremity resistance exercise training Aerobic exercise training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study consisted of two groups: one group performed upper extremity aerobic exercise while the other group performed both upper extremity aerobic exercise and upper extremity progressive resistance training.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Upper Extremity Aerobic Exercise

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

Group Type ACTIVE_COMPARATOR

Upper Extremity Aerobic Exercise Training

Intervention Type OTHER

12 weeks of upper extremity aerobic exercise training, 3 sessions per week, 25 minutes per session.

Upper Extremity Progressive Resistance Training Combined with Aerobic Exercise Training

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

Group Type EXPERIMENTAL

Upper Extremity Aerobic Exercise Training

Intervention Type OTHER

12 weeks of upper extremity aerobic exercise training, 3 sessions per week, 25 minutes per session.

Upper Extremity Progressive Resistance Exercise Training

Intervention Type OTHER

Upper extremity progressive resistance training was gradually increased over 12 weeks using elastic resistance bands.

Interventions

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Upper Extremity Aerobic Exercise Training

12 weeks of upper extremity aerobic exercise training, 3 sessions per week, 25 minutes per session.

Intervention Type OTHER

Upper Extremity Progressive Resistance Exercise Training

Upper extremity progressive resistance training was gradually increased over 12 weeks using elastic resistance bands.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Ebru Calik Kutukcu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melda Saglam, PhD

Role: STUDY_CHAIR

Hacettepe University

Ebru Calik Kutukcu, PhD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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Hcettepe University

Ankara, State, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ebru Calik Kutukcu, PhD

Role: CONTACT

Phone: +903123051576

Email: [email protected]

Naciye Vardar-Yagli, PhD

Role: CONTACT

Phone: +03123051576

Email: [email protected]

Facility Contacts

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Ebru Calik Kutukcu, PhD

Role: primary

Other Identifiers

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2025/5-47

Identifier Type: -

Identifier Source: org_study_id