Breast CancerNCT07380971
Developing a Comprehensive Exercise Service for Breast Cancer Process
An observational study of Breast Cancer, run by GO fit Lab- Ingesport at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Supervised in-person exercise training, Supervised Online Exercise Training and Home-Based Autonomous Exercise Program
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 6 Jun 2025to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women aged 18 years or older diagnosed with any type and stage of breast cancer, receiving care at Hospital Clínico San Carlos (Madrid, Spain). Participants may be at any phase of treatment (pre-surgery, during chemotherapy or radiotherapy, or in the survivorship phase). The study includes a diverse population with varying clinical profiles, physical capacities, and personal circumstances. The exercise program is inclusive and personalized, allowing participation regardless of treatment type or modality, as long as there are no medical contraindications to physical activity.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
GOfit Vallerhermoso
Madrid, Madrid, 28003
Alfonso Jiménez, +34 915902959, alfonso.jimenez@urjc.es
Ana Myriam Lavín Pérez, ana.lavin.perez@urjc.es
About this study
Official title: From Scientific Evidence to Practice: 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.
Read more
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.
Read the 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
- Being tested
- Supervised in-person exercise training, Supervised Online Exercise Training, Home-Based Autonomous Exercise Program, Gym-Based Autonomous Exercise Program, Usual Care Without Structured Exercise
- Keywords
- Exercise, Physical activity, Complementary Therapy, Personalized Exercise Program, Implementation Science, Hospital-based Exercise, Cancer Rehabilitation
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised in-person exercise trainingOther
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 TrainingOther
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 ProgramOther
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 ProgramOther
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 ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Supervised In-Person Exercise Group | Participants in this group engage in supervised, in-person exercise sessions at the GO fit Vallehermoso center. Receives: Other: Supervised in-person exercise training | |
| Supervised Online Exercise Group | Participants in this group follow the same structured exercise program as the in-person group but attend sessions via live video conferencing. Receives: Other: Supervised Online Exercise Training | |
| Autonomous Home-Based Exercise Group | Participants receive structured exercise guidelines to follow independently at home. Receives: Other: Home-Based Autonomous Exercise Program | |
| Autonomous Gym-Based Exercise Group | Participants follow individualized exercise guidelines at gym, using gym equipment for strength and aerobic training. Receives: Other: Gym-Based Autonomous Exercise Program | |
| Control Group (Usual Care) | Participants in this group do not engage in any of the structured exercise programs but continue with their standard medical care and follow-up. Receives: Other: Usual Care Without Structured Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health-Related Quality of Life (HRQoL) measured by the EORTC QLQ-C30
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.
Measured: Baseline, 4 months, 8 months, and 12 months after enrollment
Change in Health-Related Quality of Life (HRQoL) measured by the EORTC QLQ-BR42
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.
Measured: Baseline, 4 months, 8 months, and 12 months after enrollment
Secondary outcomes (29)
Change in VO2 peak during the cardiorespiratory fitness test
Measured using a submaximal test to estimate VO₂peak before and after the exercise program.
Measured: 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.
Change in heart rate response during the cardiorrespiaroty test
Measured using a submaximal test to record heart rate response before and after te exercise program.
Measured: 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.
Change in blood lactate concentration during the cardiorespiratory fitness test
Measured using a submaximal test to measure blood lactate concentration before and after the exercise program.
Measured: 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.
Change in physical activity levels
Measured using the IPAQ-SF questionnaire and daily step counts via smartphone apps or accelerometers.
Measured: Continuous monitoring; summarized at baseline, 6 and 12 months
Change in Weight
Body weight measured using a calibrated digital scale before and after the intervention.
Measured: 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.
Change in Musculoskeletal Mass
Musculoskeletal mass assessed using bioelectrical impedance analysis before and after the intervention.
Measured: 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.
Change in Body Fat Mass
Body fat mass measured by bioelectrical impedance analysis before and after the intervention.
Measured: 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.
Change in Body Mass Index
Body mass index calculated as weight (kg) divided by height squared (m²) before and after the intervention.
Measured: 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.
Change in Percentage of Body Fat (% Body Fat)
Percentage of total body fat assessed using bioelectrical impedance analysis before and after the intervention.
Measured: 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.
Change in Visceral Fat Level
Visceral fat level measured using bioelectrical impedance analysis before and after the intervention.
Measured: 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.
Change in Extracellular Water
Extracellular water assessed using bioelectrical impedance analysis before and after the intervention.
Measured: 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.
Change in Phase Angle
Phase angle obtained through bioelectrical impedance analysis as an indicator of cellular health before and after the intervention.
Measured: 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.
Change in Waist Circumference
Waist circumference measured with a flexible anthropometric tape at the midpoint between the last rib and the iliac crest before and after the intervention.
Measured: 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.
Change in Hip Circumference
Hip circumference measured with a flexible anthropometric tape at the level of the greatest posterior protuberance of the buttocks before and after the intervention.
Measured: 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.
Change in Lower Body Functional Strength
Lower body muscular strength assessed using the 30-second chair rise test before and after the intervention.
Measured: 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.
Change in Upper Body Strength
Upper body muscular strength assessed using the arm curl test (both right and left arms) before and after the intervention.
Measured: 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.
Change in Functional Mobility, Dynamic balance and Risk of falls
Functional mobility and dynamic balance assessed using the Timed Up and Go (TUG) test before and after the intervention.
Measured: 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.
Change in Static Balance
Static balance assessed using the one-leg stand test (right and left legs) before and after the intervention.
Measured: 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.
Change in Upper Body Flexibility
Upper body and shoulder flexibility assessed using the back scratch test for both right and left sides before and after the intervention.
Measured: 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.
Change in Squat Maximal Strength
Maximal lower body strength assessed through the one-repetition maximum (1RM) squat test using a linear encoder before and after the intervention.
Measured: 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.
Change in Chest Press Maximal Strength
Maximal upper body pushing strength assessed through the one-repetition maximum (1RM) chest press test using a linear encoder before and after the intervention.
Measured: 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.
Change in Incline Row Maximal Strength
Maximal upper body pulling strength assessed through the one-repetition maximum (1RM) incline row test using a linear encoder before and after the intervention.
Measured: 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.
Change in Squat Power
The power of lower body will be assessed through the squat exercise using a linear encoder before and after the intervention.
Measured: 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.
Change in Chess Press Power
The power of upper body will be assessed through the chess press exercise using a linear encoder before and after the intervention.
Measured: 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.
Change in Incline Row Power
The power of upper body will be assessed through the incline row exercise using a linear encoder before and after the intervention.
Measured: 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.
Number of exercise sessions attended per participant in each exercise program
Attendance rate to the supervised exercise sessions recorded throughout the intervention period.
Measured: Throughout the intervention period
Compliance With Prescribed Exercise Routines
Degree of compliance with the prescribed exercise program, including completion of assigned exercises, intensity, and volume.
Measured: Throughout the intervention period.
Number of participants who dropout participation in each exercise program
Number of participants who discontinue participation in the exercise program before completing the intervention period.
Measured: Throughout the intervention period.
Modification of the Prescribed Exercise Program
Requirement for modifications to the prescribed exercise program due to clinical condition, treatment-related side effects, or physical limitations of the participants.
Measured: Throughout the intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start6 Jun 2025
- Primary completionJun 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GO fit Lab- Ingesport
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380971
- Sponsor's protocol ID
- Moving Together
- Status last verified
- Jan 2026
- First submitted
- 17 Nov 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Scientific Evidence to Practice: Developing a Comprehensive Exercise Service for Breast Cancer Process
- ClinicalTrials.gov ID
- NCT07380971
- Acronym / sponsor ID
- Moving Together
- Conditions
- Breast Cancer
- Keywords
- Exercise, Physical activity, Complementary Therapy, Personalized Exercise Program, Implementation Science, Hospital-based Exercise, Cancer Rehabilitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- GO fit Lab- IngesportResearch network
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Supervised In-Person Exercise Group | – | Other: Supervised in-person exercise trainingParticipants in this group engage in supervised, in-person exercise sessions at the GO fit Vallehermoso center. |
| Supervised Online Exercise Group | – | Other: Supervised Online Exercise TrainingParticipants in this group follow the same structured exercise program as the in-person group but attend sessions via live video conferencing. |
| Autonomous Home-Based Exercise Group | – | Other: Home-Based Autonomous Exercise ProgramParticipants receive structured exercise guidelines to follow independently at home. |
| Autonomous Gym-Based Exercise Group | – | Other: Gym-Based Autonomous Exercise ProgramParticipants follow individualized exercise guidelines at gym, using gym equipment for strength and aerobic training. |
| Control Group (Usual Care) | – | Other: Usual Care Without Structured ExerciseParticipants in this group do not engage in any of the structured exercise programs but continue with their standard medical care and follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged 18 years or older diagnosed with any type and stage of breast cancer, receiving care at Hospital Clínico San Carlos (Madrid, Spain). Participants may be at any phase of treatment (pre-surgery, during chemotherapy or radiotherapy, or in the survivorship phase). The study includes a diverse population with varying clinical profiles, physical capacities, and personal circumstances. The exercise program is inclusive and personalized, allowing participation regardless of treatment type or modality, as long as there are no medical contraindications to physical activity.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised in-person exercise trainingParticipants 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 In-Person Exercise Group |
| Supervised Online Exercise TrainingParticipants 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 | Supervised Online Exercise Group |
| Home-Based Autonomous Exercise ProgramParticipants 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 | Autonomous Home-Based Exercise Group |
| Gym-Based Autonomous Exercise ProgramParticipants 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 | Autonomous Gym-Based Exercise Group |
| Usual Care Without Structured ExerciseParticipants 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. | Other | Control Group (Usual Care) |
Primary outcome
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.
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.
29 secondary outcomes
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.
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.
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.
Change in physical activity levels
Time frame: Continuous monitoring; summarized at baseline, 6 and 12 months
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Number of exercise sessions attended per participant in each exercise program
Time frame: Throughout the intervention period
Compliance With Prescribed Exercise Routines
Time frame: Throughout the intervention period.
Number of participants who dropout participation in each exercise program
Time frame: Throughout the intervention period.
Modification of the Prescribed Exercise Program
Time frame: Throughout the intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by GO fit Lab- Ingesport at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.