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NCT Number: NCT07380971

Developing a Comprehensive Exercise Service for Breast Cancer Process

"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.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

GOfit Vallerhermoso

Madrid, 28003, Spain

Location status: Recruiting

Location contact

Alfonso Jiménez

CONTACT

[email protected]

+34 915902959

Ana Myriam Lavín Pérez

CONTACT

[email protected]

María Josefa Herrera de la Muela

PRINCIPAL_INVESTIGATOR

About this study

"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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Supervised in-person exercise training

Other

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.

Supervised Online Exercise Training

Other

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.

Home-Based Autonomous Exercise Program

Other

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.

Gym-Based Autonomous Exercise Program

Other

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.

Usual Care Without Structured Exercise

Other

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.

Primary outcomes

  1. Change in Health-Related Quality of Life (HRQoL) measured by the EORTC QLQ-C30

    Time frame: Baseline, 4 months, 8 months, and 12 months after enrollment

    Health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). This instrument includes functional scales, symptom scales, and a global health status scale, all scored from 0 to 100. Higher scores on functional and global health scales indicate better quality of life, whereas higher scores on symptom scales indicate greater symptom burden. The outcome is the change in QLQ-C30 scores from baseline to 4, 8, and 12 months.

  2. Change in Health-Related Quality of Life (HRQoL) measured by the EORTC QLQ-BR42

    Time frame: Baseline, 4 months, 8 months, and 12 months after enrollment

    HRQoL specific to breast cancer will be assessed using the EORTC Breast Cancer-Specific Module (QLQ-BR42). This questionnaire produces scores ranging from 0 to 100. Higher symptom scores indicate worse symptom burden.

Secondary outcomes

  1. Change in VO2 peak during the cardiorespiratory fitness test

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    Measured using a submaximal test to estimate VO₂peak before and after the exercise program.

  2. Change in heart rate response during the cardiorrespiaroty test

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    Measured using a submaximal test to record heart rate response before and after te exercise program.

  3. Change in blood lactate concentration during the cardiorespiratory fitness test

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    Measured using a submaximal test to measure blood lactate concentration before and after the exercise program.

  4. Change in physical activity levels

    Time frame: Continuous monitoring; summarized at baseline, 6 and 12 months

    Measured using the IPAQ-SF questionnaire and daily step counts via smartphone apps or accelerometers.

  5. Change in Weight

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    Body weight measured using a calibrated digital scale before and after the intervention.

  6. Change in Musculoskeletal Mass

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    Musculoskeletal mass assessed using bioelectrical impedance analysis before and after the intervention.

  7. Change in Body Fat Mass

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    Body fat mass measured by bioelectrical impedance analysis before and after the intervention.

  8. Change in Body Mass Index

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    Body mass index calculated as weight (kg) divided by height squared (m²) before and after the intervention.

  9. Change in Percentage of Body Fat (% Body Fat)

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    Percentage of total body fat assessed using bioelectrical impedance analysis before and after the intervention.

  10. Change in Visceral Fat Level

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    Visceral fat level measured using bioelectrical impedance analysis before and after the intervention.

  11. Change in Extracellular Water

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    Extracellular water assessed using bioelectrical impedance analysis before and after the intervention.

  12. Change in Phase Angle

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    Phase angle obtained through bioelectrical impedance analysis as an indicator of cellular health before and after the intervention.

  13. Change in Waist Circumference

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    Waist circumference measured with a flexible anthropometric tape at the midpoint between the last rib and the iliac crest before and after the intervention.

  14. Change in Hip Circumference

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    Hip circumference measured with a flexible anthropometric tape at the level of the greatest posterior protuberance of the buttocks before and after the intervention.

  15. Change in Lower Body Functional Strength

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    Lower body muscular strength assessed using the 30-second chair rise test before and after the intervention.

  16. Change in Upper Body Strength

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    Upper body muscular strength assessed using the arm curl test (both right and left arms) before and after the intervention.

  17. Change in Functional Mobility, Dynamic balance and Risk of falls

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    Functional mobility and dynamic balance assessed using the Timed Up and Go (TUG) test before and after the intervention.

  18. Change in Static Balance

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    Static balance assessed using the one-leg stand test (right and left legs) before and after the intervention.

  19. Change in Upper Body Flexibility

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    Upper body and shoulder flexibility assessed using the back scratch test for both right and left sides before and after the intervention.

  20. Change in Squat Maximal Strength

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    Maximal lower body strength assessed through the one-repetition maximum (1RM) squat test using a linear encoder before and after the intervention.

  21. Change in Chest Press Maximal Strength

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    Maximal upper body pushing strength assessed through the one-repetition maximum (1RM) chest press test using a linear encoder before and after the intervention.

  22. Change in Incline Row Maximal Strength

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    Maximal upper body pulling strength assessed through the one-repetition maximum (1RM) incline row test using a linear encoder before and after the intervention.

  23. Change in Squat Power

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    The power of lower body will be assessed through the squat exercise using a linear encoder before and after the intervention.

  24. Change in Chess Press Power

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    The power of upper body will be assessed through the chess press exercise using a linear encoder before and after the intervention.

  25. Change in Incline Row Power

    Time frame: Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.

    The power of upper body will be assessed through the incline row exercise using a linear encoder before and after the intervention.

  26. Number of exercise sessions attended per participant in each exercise program

    Time frame: Throughout the intervention period

    Attendance rate to the supervised exercise sessions recorded throughout the intervention period.

  27. Compliance With Prescribed Exercise Routines

    Time frame: Throughout the intervention period.

    Degree of compliance with the prescribed exercise program, including completion of assigned exercises, intensity, and volume.

  28. Number of participants who dropout participation in each exercise program

    Time frame: Throughout the intervention period.

    Number of participants who discontinue participation in the exercise program before completing the intervention period.

  29. Modification of the Prescribed Exercise Program

    Time frame: Throughout the intervention period

    Requirement for modifications to the prescribed exercise program due to clinical condition, treatment-related side effects, or physical limitations of the participants.

Sponsors and collaborators

Lead sponsor

GO fit Lab- Ingesport

Network

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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