NCT07380971

Developing a Comprehensive Exercise Service for Breast Cancer Process

From Scientific Evidence to Practice: Developing a Comprehensive Exercise Service for Breast Cancer Process

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: GO fit Lab- Ingesport · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

"Moving Together" (Juntas en Movimiento) is a hospital-based, comprehensive, and personalized exercise service designed for women diagnosed with breast cancer. This implementation study aims to evaluate the feasibility, safety, and impact of integrating a free, tailored exercise program into routine clinical care at Hospital Clínico San Carlos in Madrid, Spain. The program offers multiple participation options-supervised in-person, supervised online, autonomous at home, or autonomous at a fitness center-allowing patients to choose based on their preferences, limitations, and treatment phase (pre-surgery, during chemotherapy/radiotherapy, or survivorship). All exercise options are adapted to individual needs and include aerobic and resistance training components. The study uses a real-world implementation science approach, guided by the Consolidated Framework for Implementation Research (CFIR), to assess clinical, physical, and psychological outcomes such as quality of life, cardiorespiratory fitness, muscle strength, body composition, and adherence to physical activity. Data are collected through clinical records, physical assessments, validated questionnaires, and wearable technology. This pioneering initiative in Spain seeks to establish exercise as a standard complementary therapy in oncology care, bridging the gap between scientific evidence and clinical practice, and promoting long-term health and well-being in breast cancer patients.

Detailed description

"Moving Together" (Juntas en Movimiento) is an implementation research project that evaluates the integration of a comprehensive, free, and personalized exercise service into the clinical care of women with breast cancer. The service is embedded within the Breast Unit of Hospital Clínico San Carlos (Madrid, Spain) and is developed in collaboration with King Juan Carlos University and GO fit Vallehermoso. The program is designed to be inclusive and adaptable, offering four participation modalities: * Supervised in-person sessions at a fitness center. * Supervised online sessions via video conferencing. * Autonomous home-based training with structured guidelines. * Autonomous training at a gym with tailored routines. Patients can join the program at any stage of their cancer journey-before surgery, during chemotherapy or radiotherapy, or in the survivorship phase. The exercise protocols are adapted to each phase and personalized based on clinical status, physical capacity, preferences, and daily symptoms. Supervised sessions include real-time heart rate monitoring and are delivered in small groups to foster social support. The implementation follows the CFIR model, analyzing internal and external factors that influence adoption, sustainability, and scalability. The program is supported by interdisciplinary collaboration among oncologists, gynecologists, exercise scientists, and clinical staff. Healthcare professionals receive specific training to promote exercise as part of cancer care. Assessments include: * Clinical data (tumor type/stage, treatments, biomarkers). * Physical evaluations (body composition, strength, flexibility, balance, cardiorespiratory fitness). * Psychological and behavioral measures (quality of life, physical activity levels, perceived barriers/benefits, adherence). Data are collected using REDCap and wearable devices (e.g., accelerometers, heart rate monitors). Behavioral change strategies, including the COM-B model and the PADEX checklist, are applied to enhance motivation, self-efficacy, and long-term adherence. The program also fosters a supportive community through workshops, group sessions, and family-inclusive events. It aims to humanize care, empower patients, and create a sustainable model for integrating exercise into oncology services. This initiative not only improves patient outcomes but also creates a real-world research platform to explore the effects of exercise across different cancer stages and patient profiles. Future randomized controlled trials will be embedded within the service to refine exercise prescriptions and optimize clinical impact.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	Supervised in-person exercise training	Participants attend 60-minute, twice-weekly exercise sessions at GO fit Vallehermoso. Sessions include warm-up, aerobic and resistance training, and cool-down. Exercises are tailored to the patient's treatment phase (pre-surgery, during chemotherapy/radiotherapy, or survivorship) and adjusted based on symptoms like fatigue or pain. Heart rate is monitored in real time. Groups are formed by treatment phase and physical capacity to ensure safety and personalization.
OTHER	Supervised Online Exercise Training	Participants follow the same structure as the in-person group but attend sessions via live video conferencing. They receive equipment and training on using the MYZONE app for heart rate monitoring. Sessions are interactive, allowing real-time feedback and social support. This option is designed for patients with mobility, time, or travel limitations.
OTHER	Home-Based Autonomous Exercise Program	Participants receive structured exercise guidelines to follow independently at home. Programs include aerobic and strength exercises using bodyweight or household items, with three levels of progression. Training is recommended 1-3 times per week. Participants track activity using a diary and smartphone accelerometer. Programs are adapted to treatment phase and personal capacity.
OTHER	Gym-Based Autonomous Exercise Program	Participants follow individualized exercise guidelines at the gym, using gym equipment for strength and aerobic training. The program is self-directed but based on the same structure and progression as supervised programs. Activity is tracked via accelerometers and exercise logs. Participants choose this option based on preference and access to gym facilities.
OTHER	Usual Care Without Structured Exercise	Participants in this group do not receive any structured exercise intervention. They continue with standard medical care and follow-up as prescribed by their oncology team. They undergo the same clinical, physical, and psychological assessments as the intervention groups to allow for comparison of outcomes.

Timeline

• Start date: 2025-06-06
• Primary completion: 2028-06-01
• Completion: 2030-12-01
• First posted: 2026-02-02
• Last updated: 2026-02-02

Locations

1 site across 1 country: Spain