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

NCT ID: NCT06672380

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2024-01-29

Brief 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.

Detailed Description

Ethical Considerations To meet ethical standards, this study, commenced after approval by the Ethics and Research Committee of the School of Nutrition at the Federal University of Bahia (ENUFBA) and the participating institution. Eligible patients were invited to sign the Free and Informed Consent Form (ICF) after receiving all relevant project information, especially regarding procedures and methodology.

It is noteworthy that this project has already been approved-approval numbers 3.935.544 from ENUFBA and 4.185.408 from Santo Antônio Hospital/Sister Dulce Social Works. The study was conducted in accordance with all regulatory guidelines and standards for research involving human subjects as outlined in Resolution 466/2012 of the National Health Council. Participation in the research was voluntary, and all patient information will be kept confidential. Patients who chose not to participate in the study protocol will continue to receive medical and nutritional follow-up at the clinic.

Conditions

Breast Cancer Survivor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Structured and remotely guided physical exercise program for women who are breast cancer survivors

Structured and remotely guided physical exercise program The participants in this group took part in a remote exercise program for 3 months, with three classes a week, each lasting 1 hour on alternate days. This group had a more active follow-up, with personalized instruction and ongoing support to improve their physical and emotional health.

Group Type: EXPERIMENTAL

Remote Physical Exercise Program for Breast Cancer Survivors

Intervention Type: OTHER

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).

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

Arm 2: Initial Consultation and Exercise Guidance via Ebook The participants in this group received an initial consultation, where they were presented with health guidelines and an eBook containing information and guidance on physical exercise. After 30 days, they were given additional encouragement via text message to reinforce physical activity through the eBook, but there was no ongoing direct interaction.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

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.

Initial Incentive for Eating Habits in Women Surviving Breast Cancer

Arm 3: 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.

Group Type: PLACEBO_COMPARATOR

Initial Incentive for Eating Habits in Women Surviving Breast Cancer

Intervention Type: OTHER

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Online Fitness Training for Female Cancer Survivors; Distance Physical Activity Program for Breast Cancer Survivors; Virtual Exercise Intervention for Women Recovering from Cancer; Remote Exercise Classes for Breast Cancer Survivors; Remote Fitness Program for Women with Breast Cancer; Structured and remotely guided physical exercise program; Initial Consultation and Exercise Guidance via Ebook

Eligibility Criteria

Inclusion Criteria

• Had completed breast cancer treatment (surgery, chemotherapy and/or radiotherapy) at least three months previously.
• Had medical clearance to practice physical activity.
• Were interested in voluntarily participating in the protocol.

Exclusion Criteria

• They had locomotion or joint limitations that could prevent them from exercising.
• Had psychiatric limitations.
• Were pregnant or breastfeeding.
• Had been doing guided physical activity for at least three months prior to the intervention.
• Did not have access to appropriate technology for remote activities.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Bahia

OTHER

Sponsor Role: lead

Responsible Party

DARIO DA SILVA MONTE NERO

Master of Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dario SM Nero, Master

Role: PRINCIPAL_INVESTIGATOR

Federal University of Bahia

Locations

School of Nutrition-Universidade Federal da Bahia

Salvador, Estado de Bahia, Brazil

Countries

Brazil

Other Identifiers

001-PAF-SBM-2024

Identifier Type: -

Identifier Source: org_study_id