The True Face of the Pyramid; Physical Activity Level and Cardiovascular Risk in Patients With Breast Cancer

NCT06837701 | Completed

• 1 other identifier: SBA 24/664
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular disease (CVD) is the leading cause of morbidity and mortality worldwide. Many risk factors are thought to be important in the development of CVD; however, some risk factors can be controlled. Regular physical activity (PA) is recommended for the entire population for the primary prevention of CVD. PA and physical health are also believed to reduce other CVD risk factors such as body mass index, blood pressure and stress. Although oncological outcome is the most important factor for breast cancer survivors, CVD has emerged as an important cause of death among them. In particular, CVD mortality is known to increase 7 years after breast cancer diagnosis, and death due to CVD is more common in older patients than death from cancer. Higher levels of physical activity compared to low levels measured prior to breast cancer diagnosis were associated with statistically significantly lower all-cause mortality among women diagnosed with breast cancer. For breast cancer survivors, increasing PA during and after treatment has been reported to be safe and effective in improving cancer survival, alleviating cancer-related symptoms and improving quality of life. However, there is a lack of evidence regarding the effect of PA on cardiovascular outcomes in long-term breast cancer survivors.

Conditions

Breast Cancer; Cardiovascular Disease; Physical Activity

Keywords

breast cancer; Cardiovascular disease; Physical activity

Outcome Measures

Primary Outcomes (3)

• Physical Activity Level

  Physical activity level was assessed using a multisensorial PA monitor. The SenseWear Armband (Armband Model MF-SW, BodyMedia, Pittsburgh, USA) was worn on the back of the left-side upper arm over the triceps for at least 7 consecutive days, except for times requiring contact with water, such as bathing and swimming. The monitor estimates energy expenditure using measurements from tri-axial accelerometers and sensors (galvanic skin response, heat flux, and skin temperature). The measured outputs of the SWA is step count

  One Year

• Cardiovascular Disease Risk Scoring

  SCORE2

  One Year

• Functional exercise capacity

  6 minutes walk test

  one year

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study Population: Patients between the ages of 40-80 years who were diagnosed with breast cancer in Hacettepe University Hospital, Department of Internal Medicine, Department of Medical Oncology and volunteered to participate in the study will be included in the study.

You may qualify if:

• To be between the ages of 40-80 years,
• Volunteering to participate in the research,
• At least 15 months after breast cancer surgery,
• months after active breast cancer treatment (ie surgery/chemotherapy)
• Having no problem in reading and/or understanding the scales and being able to cooperate with the tests.

You may not qualify if:

• Presence of active infection,
• Having a neurological disease or other clinical diagnosis that may affect cognitive status,
• Having musculoskeletal and neurological disease, symptomatic heart disease, previous lung surgery and malignant disease that may affect exercise performance.
• Presence of unstable hypertension or diabetes mellitus

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, State, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms; Cardiovascular Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Ebru Calik Kutukcu, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 20, 2025
• Study Start: July 30, 2024
• Primary Completion: May 29, 2025
• Study Completion: September 15, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

TU (1)