The INFLUENCE of PHYSICAL ACTIVITY on the HEALTH and WELL-BEING of BREAST CANCER SURVIVORS

NCT06672380 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-11-04

No results posted yet for this study

Summary

Introduction: Cancer remains a leading cause of death globally, with breast cancer being the most common type among women worldwide. The risk of breast cancer is influenced by genetic and lifestyle factors. Healthy dietary habits, regular physical activity, and maintaining a healthy body weight not only reduce the risk of primary neoplastic lesions but also help prevent recurrence. Objective: To assess the impact of educational strategies on behavioral changes, health, and quality of life in women following breast cancer treatment. Methods: This randomized intervention study included 32 participants divided into three groups: remote exercise intervention, e-book guidance, and control. The 12-week intervention involved three weekly sessions with a physical educator and a nutritional consultation. Primary outcomes focused on quality of life, sleep quality, and perceived stress, while secondary outcomes assessed clinical data on biochemical markers, blood pressure, morphofunctional parameters (strength, flexibility, cardiorespiratory capacity), and comorbidities. Women who completed initial breast cancer treatment (surgery, chemotherapy, radiotherapy) and voluntarily participated in the lifestyle program were included in the study. Participants were recruited through invitation letters sent to eligible women from an oncology reference clinic in Salvador. At baseline, standardized questionnaires collected sociodemographic data (age, origin, race, education level), clinical information, and lifestyle habits (smoking, alcohol consumption). Specific questionnaires gathered details on physical activity level (IPAQ), quality of life (SF-36), perceived stress (PSS), sleep quality (PSQI), and morphofunctional assessments (strength tests, BMI, and waist circumference). The questionnaires were administered in person, along with assessments of anthropometric data (BMI, waist circumference), upper and lower limb strength (dynamometry and chair-stand test), cardiorespiratory fitness test, standardized questionnaires, and a 24-hour dietary recall (R24h). Additionally, protocols such as IPAQ, SF-36, PSS, PSQI, and dietary quality questionnaires were used. Intervention: The study intervention focused on developing knowledge about healthy lifestyle habits, emphasizing the benefits of dietary and exercise changes, and promoting motivation and self-confidence to sustain health-oriented behavioral changes. This intervention is anticipated to promote improvements in participant health and lifestyle, impacting their physical health and quality of life.

Conditions

  • Breast Cancer Survivor

Interventions

OTHER

Remote Physical Exercise Program for Breast Cancer Survivors

Structured and remotely guided physical exercise program The participants in the intervention group took part in a remote physical exercise program for 12 weeks. The telepresence sessions, conducted three times a week via Google Meet®, lasted 60 minutes and consisted of three phases: warm-up (10 minutes), multi-joint functional exercises (40 minutes) and stretching (10 minutes). The exercises were progressively intensified over the weeks, using the Borg scale to monitor effort. The intensity was adjusted in three cycles: in the first 4 weeks (60 seconds of exercise/90 seconds of rest), in weeks 5 to 8 (75 seconds of exercise/60 seconds of rest) and in weeks 9 to 12 (90 seconds of exercise/30 seconds of rest).

OTHER

Initial Consultation and Exercise Guidance via Ebook for Women Surviving Breast Cance

Participants in the Ebook group received an illustrated manual containing detailed guidelines for practicing simple physical exercises at home, using only their body weight. The manual suggested a frequency of 3 to 5 times a week, with 30 to 60 minutes of activities such as stretching, squats and exercises for the upper and lower limbs. The participants were encouraged to follow these guidelines and, 30 days after receiving the ebook, an additional stimulus was sent by text message, reinforcing the importance of following the protocol.

OTHER

Initial Incentive for Eating Habits in Women Surviving Breast Cancer

The control group only received general guidance on the importance of regular physical activity. The recommendations followed health guidelines, suggesting between 150 and 300 minutes of moderate-intensity physical activity per week.

Sponsors & Collaborators

  • Federal University of Bahia

    lead OTHER

Principal Investigators

  • Dario SM Nero, Master · Federal University of Bahia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-15
Primary Completion
2024-01-29
Completion
2024-01-29

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06672380 on ClinicalTrials.gov