RecruitingNCT07380971

Developing a Comprehensive Exercise Service for Breast Cancer Process

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

Sponsor

GO fit Lab- Ingesport

Enrollment

200 participants

Start Date

Jun 6, 2025

Study Type

OBSERVATIONAL

Conditions

Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

Women aged 18 years or older.
Diagnosed with any type and stage of breast cancer.
Receiving care at Hospital Clínico San Carlos (Madrid, Spain).
Willing and able to provide informed consent.
Eligible to participate in physical activity based on clinical evaluation.

Exclusion Criteria4

Medical contraindications to physical exercise.
Severe uncontrolled conditions (whether related to cancer treatment or not).
Diagnosis of recurrent breast cancer.
Refusal or inability to sign the informed consent form.

Interventions

OTHERSupervised 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.

OTHERSupervised 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.

OTHERHome-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.

OTHERGym-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.

OTHERUsual 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.