Breast CancerNCT07070791
Combined Upper Extremity Resistance and Aerobic Exercise Training in Patients With Breast Cancer
A study testing Upper Extremity Aerobic Exercise Training and Upper Extremity Progressive Resistance Exercise Training in people with Breast Cancer and Upper Extremity, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Upper Extremity, Resistance Exercise
- What is being tested?
- Upper Extremity Aerobic Exercise Training and Upper Extremity Progressive Resistance Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jul 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 <).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hcettepe University
Ankara, State, 06100
Ebru Calik Kutukcu, PhD, +903123051576 ext. 195, ebru.calik@hacettepe.edu.tr
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer, Upper Extremity, Resistance Exercise, Aerobic Exercise
- Being tested
- Upper Extremity Aerobic Exercise Training, Upper Extremity Progressive Resistance Exercise Training
- Keywords
- breast cancer, Upper Extremity, resistance exercise training, Aerobic exercise training
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper Extremity Aerobic Exercise TrainingOther
12 weeks of upper extremity aerobic exercise training, 3 sessions per week, 25 minutes per session.
Upper Extremity Progressive Resistance Exercise TrainingOther
Upper extremity progressive resistance training was gradually increased over 12 weeks using elastic resistance bands.
| Study group | Role | What they receive |
|---|---|---|
| Upper Extremity Aerobic Exercise | Active comparator | Participants will only receive a 12-week upper limb aerobic exercise training program. Receives: Other: Upper Extremity Aerobic Exercise Training |
| 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. Receives: Other: Upper Extremity Aerobic Exercise Training; Other: Upper Extremity Progressive Resistance Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute Pegboard and Ring Test - 6PBRT
Total number of rings inserted in six minutes
Measured: One Year
Maximal Arm Exercise Capacity
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)
Measured: One Year
Secondary outcomes (9)
Evaluation of Quality of Life
European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) All scores were linearly transformed to a 0 to 100 scale. A high or healthy level of functioning is represented by a high functional score
Measured: One Year
Peripheral Muscle Strength
Hand grip strength by hand dynamometer
Measured: One Year
Anthropometric Measurements
Arm Circumference
Measured: One Year
Comorbidity Assessment
The Charlson Comorbidity Index According to this index developed by the Institute of Medicine, comorbid diseases are assessed according to their severity. is scored. Comorbidities are scored from mild disease state to severe disease state. are given a score of 1, 2, 3, 4, respectively, and the score obtained by summing the scores of comorbid diseases The severity of comorbidity is also calculated according to the weighted score. One point for every ten years over the age of forty (50-59: 1 point, 60-69: 2 points, etc.)
Measured: One Year
Peripheral muscle strength assessment
Peripheral muscle strength (knee extensors, shoulder abductors and hand grip strength) will be measured using a handheld digital dynamometer
Measured: One Year
Evaluation of Upper Extremity Functionality
Questionnaire Disability of Arm, Shoulder and Hand (Q-DASH) Each item is scored on a 5-point Likert scale (1-5).The maximum score is 100 points. Score increase shows an increase in disability.
Measured: One Year
Assessment of Sarcopenia
According to EWGSOP2, probable sarcopenia is defined by the first criterion and confirmed sarcopenia by the first and second criteria. Severe sarcopenia is considered if all three criteria are present.
Measured: One Year
Assessment of Frailty Status
Those who do not fulfil any of the criteria are defined as non-fragile group and those who fulfil 1 or 2 of the criteria are defined as pre-fragile group.
Measured: One Year
Lymphoedema Evaluation
Using circumference measurements starting from the wrist, the volume of the upper extremity was calculated by using an excel programme (Calculator: John Chambers) which calculates the volume by taking the sum of the volumes of truncated cones standing on top of each other. Lymphedema was considered positive in patients with a volume difference of more than 200 ml between the two arms.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start8 Jul 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Calik, Hacettepe University
- Investigators
- Melda Saglam, PhD, Study chair, Hacettepe UniversityEbru Calik Kutukcu, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070791
- Sponsor's protocol ID
- 2025/5-47
- Status last verified
- Sep 2026
- First submitted
- 9 Jul 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07070791
- Acronym / sponsor ID
- 2025/5-47
- Conditions
- Breast Cancer, Upper Extremity, Resistance Exercise, Aerobic Exercise
- Keywords
- breast cancer, Upper Extremity, resistance exercise training, Aerobic exercise training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Upper Extremity Aerobic Exercise | Active comparator | Other: Upper Extremity Aerobic Exercise TrainingParticipants will only receive a 12-week upper limb aerobic exercise training program. |
| Upper Extremity Progressive Resistance Training Combined with Aerobic Exercise Training | Experimental | Other: Upper Extremity Aerobic Exercise Training, Other: Upper Extremity Progressive Resistance Exercise TrainingParticipants will receive a 12-week upper extremity aerobic exercise training program plus upper extremity progressive resistance exercise training. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 <).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper Extremity Aerobic Exercise Training12 weeks of upper extremity aerobic exercise training, 3 sessions per week, 25 minutes per session. | Other | Upper Extremity Aerobic Exercise, Upper Extremity Progressive Resistance Training Combined with Aerobic Exercise Training |
| Upper Extremity Progressive Resistance Exercise TrainingUpper extremity progressive resistance training was gradually increased over 12 weeks using elastic resistance bands. | Other | Upper Extremity Progressive Resistance Training Combined with Aerobic Exercise Training |
Primary outcome
6 minute Pegboard and Ring Test - 6PBRT
Time frame: One Year
Total number of rings inserted in six minutes
Maximal Arm Exercise Capacity
Time frame: 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)
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melda Saglam, PhD study chair
Hacettepe University
Ebru Calik Kutukcu, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper Extremity Aerobic Exercise Training and Upper Extremity Progressive Resistance Exercise Training in people with Breast Cancer and Upper Extremity, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ebru Calik Kutukcu, PhD (+903123051576 ext. 195, ebru.calik@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute Pegboard and Ring Test - 6PBRT (time frame: One Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.