Aerobic ExerciseNCT07070778
Arterial Stiffness in Individuals With Breast Cancer
A study testing Upper Extremity Aerobic Exercise Training Program in people with Aerobic Exercise and Breast Cancer, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate vascular toxicity induced by anthracyclines and other anticancer drugs and to measure arterial stiffness in women with breast cancer and, in addition, to evaluate the acute and chronic arterial stiffness responses of upper extremity aerobic exercise training. Read more about this study
- Who is it for?
- Ages 40 to 69 years, women only
- Conditions the study is for
- Aerobic Exercise, Breast Cancer, Arterial Stiffness
- What is being tested?
- Upper Extremity Aerobic Exercise Training Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 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 40 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be between the ages of 40-69,
- Baseline left ventricular ejection fraction (LVEF) >50%,
- Absence of coronary artery disease and haemodynamically significant valvular heart disease,
- Absence of carotid atherosclerotic plaques,
- 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,
- Left ventricular dysfunction and severe liver and kidney dysfunction before starting chemotherapy
- 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
Hacettepe University
Ankara, State, 06100
Ebru Calik Kutukcu, PhD, +903123051576 ext. 195, ebru.calik@hacettepe.edu.tr
About this study
Official title: The Effect of Upper Extremity Aerobic Exercise Training on Arterial Stiffness in Individuals With Breast Cancer
The aim of this study was to evaluate vascular toxicity induced by anthracyclines and other anticancer drugs and to measure arterial stiffness in women with breast cancer and, in addition, to evaluate the acute and chronic arterial stiffness responses of upper extremity aerobic exercise training.
Read the detailed description
Breast cancer is the most common type of cancer in women both in the world and in our country. Today, with the technological developments, breast cancer treatments have improved considerably and the mortality rate has decreased. However, despite the developments in treatments, the quality of life of patients has still not reached the desired level. Upper extremity dysfunctions are frequently observed in patients after breast cancer treatment. This upper extremity dysfunction causes a decrease in the quality of daily life of patients. Arterial stiffness contributes to hypertension and increases the risk of cardiovascular disease. The American College of Sports Medicine (ACSM) recommends that healthy adults perform moderate to vigorous intensity aerobic exercise at least 5 times per week and resistance exercise 2-3 times per week. Aerobic exercise can reduce arterial stiffness after both acute and chronic interventions. A small number of studies on aerobic exercise have reported that this exercise training improves the functional level of patients after breast cancer. However, the effect of aerobic exercise training on arm exercise capacity and arterial stiffness in patients with breast cancer is still unclear. Thus, the results of this study may guide physiotherapists working in this field about upper extremity exercise training after breast cancer.
- Conditions
- Aerobic Exercise, Breast Cancer, Arterial Stiffness
- Being tested
- Upper Extremity Aerobic Exercise Training Program
- Keywords
- breast cancer, Aerobic exercise training, Arterial Stiffness
- 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 Training ProgramOther
12 weeks of supervised upper limb aerobic exercise training, 3 sessions per week, 25 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| Upper Extremity Aerobic Exercise | Other | Participants will only receive a 12-week upper extremity aerobic exercise training program. Receives: Other: Upper Extremity Aerobic Exercise Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Stiffness
Arterial stiffness will be assessed noninvasively using the pulse wave velocity (PWV) technique with the Mobil-O-GRAPH (TG) (I.E.M., Stolberg, Germany), an oscillometer-based device. Pulse wave velocity, augmentation pressure, reflection magnitude, agumentation index parameters will be recorded.
Measured: one years
Secondary outcomes (3)
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
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
Cardiovascular Disease Risk Scoring
To be evaluated with SCORE2. The risk calculated according to the SCORE system is accepted as low risk if <1%, medium risk if 1-4%, high risk if 5-9%, and very high risk if 10% and above (16). According to the SCORE2 system, <2.5% is considered low-moderate risk, 2.5%-7.5% is considered high risk, and 7.5% and above is considered very high risk in patients aged <50 years. In those over 50 years of age, <5% is considered low-moderate risk, 5-10% is considered high risk, and 10% and above is considered very high risk.
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 Aerobic ExerciseStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The study consists of one group: this group performs upper extremity aerobic exercise training.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Calik Kutukcu, Hacettepe University
- Investigators
- Melda Saglam, PhD, Study chair, Hacettepe UniversityEbru Calik Kutukcu, PhD, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070778
- Sponsor's protocol ID
- 2025/5-39
- Status last verified
- Dec 2025
- First submitted
- 9 Jul 2025
- Last updated
- 29 Dec 2025
- 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 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Upper Extremity Aerobic Exercise Training on Arterial Stiffness in Individuals With Breast Cancer
- ClinicalTrials.gov ID
- NCT07070778
- Acronym / sponsor ID
- 2025/5-39
- Conditions
- Aerobic Exercise, Breast Cancer, Arterial Stiffness
- Keywords
- breast cancer, Aerobic exercise training, Arterial Stiffness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 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.
The aim of this study was to evaluate vascular toxicity induced by anthracyclines and other anticancer drugs and to measure arterial stiffness in women with breast cancer and, in addition, to evaluate the acute and chronic arterial stiffness responses of upper extremity aerobic exercise training.
Detailed description
Breast cancer is the most common type of cancer in women both in the world and in our country. Today, with the technological developments, breast cancer treatments have improved considerably and the mortality rate has decreased. However, despite the developments in treatments, the quality of life of patients has still not reached the desired level. Upper extremity dysfunctions are frequently observed in patients after breast cancer treatment. This upper extremity dysfunction causes a decrease in the quality of daily life of patients. Arterial stiffness contributes to hypertension and increases the risk of cardiovascular disease. The American College of Sports Medicine (ACSM) recommends that healthy adults perform moderate to vigorous intensity aerobic exercise at least 5 times per week and resistance exercise 2-3 times per week. Aerobic exercise can reduce arterial stiffness after both acute and chronic interventions. A small number of studies on aerobic exercise have reported that this exercise training improves the functional level of patients after breast cancer. However, the effect of aerobic exercise training on arm exercise capacity and arterial stiffness in patients with breast cancer is still unclear. Thus, the results of this study may guide physiotherapists working in this field about upper extremity exercise training after breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study consists of one group: this group performs upper extremity aerobic exercise training.
| Arm | Type | Receives |
|---|---|---|
| Upper Extremity Aerobic Exercise | Other | Other: Upper Extremity Aerobic Exercise Training ProgramParticipants will only receive a 12-week upper extremity aerobic exercise training program. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- To be between the ages of 40-69,
- Baseline left ventricular ejection fraction (LVEF) >50%,
- Absence of coronary artery disease and haemodynamically significant valvular heart disease,
- Absence of carotid atherosclerotic plaques,
- Volunteering to participate in the research,
Key exclusion criteria (7 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,
- Left ventricular dysfunction and severe liver and kidney dysfunction before starting chemotherapy
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 Training Program12 weeks of supervised upper limb aerobic exercise training, 3 sessions per week, 25 minutes per session. | Other | Upper Extremity Aerobic Exercise |
Primary outcome
Arterial Stiffness
Time frame: one years
Arterial stiffness will be assessed noninvasively using the pulse wave velocity (PWV) technique with the Mobil-O-GRAPH (TG) (I.E.M., Stolberg, Germany), an oscillometer-based device. Pulse wave velocity, augmentation pressure, reflection magnitude, agumentation index parameters will be recorded.
3 secondary outcomes
Comorbidity Assessment
Time frame: one year
Maximal Arm Exercise Capacity
Time frame: one year
Cardiovascular Disease Risk Scoring
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 29 Dec 2025.
- 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 study director
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 Program in people with Aerobic Exercise and Breast Cancer, 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 8 inclusion and 7 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 29 Dec 2025. 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?
Arterial Stiffness (time frame: one years). 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 29 Dec 2025.