Developing a Comprehensive Exercise Service for Breast Cancer Process

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Supervised in-person exercise training; Other: Supervised Online Exercise Training; Other: Home-Based Autonomous Exercise Program; Other: Gym-Based Autonomous Exercise Program; Other: Usual Care Without Structured Exercise

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28003
      • Recruiting
      • GOfit Vallerhermoso
      • Contact: Alfonso Jiménez; Phone Number: +34 915902959; Email: alfonso.jimenez@urjc.es
      • Contact: Ana Myriam Lavín Pérez; Email: ana.lavin.perez@urjc.es
      • Principal Investigator: María Josefa Herrera de la Muela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Supervised In-Person Exercise Group; Participants in this group engage in supervised, in-person exercise sessions at the GO fit Vallehermoso center.	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.
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.	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.
Autonomous Home-Based Exercise Group; Participants receive structured exercise guidelines to follow independently at home.	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.
Autonomous Gym-Based Exercise Group; Participants follow individualized exercise guidelines at gym, using gym equipment for strength and aerobic training.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, 4 months, 8 months, and 12 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in VO2 peak during the cardiorespiratory fitness test	Measured using a submaximal test to estimate VO₂peak before and after the exercise program.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Throughout the intervention period

Collaborators and Investigators

• Sponsor: GO fit Lab- Ingesport

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: January 23, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Exercise; Physical activity; Implementation Science; Complementary Therapy; Cancer Rehabilitation; Personalized Exercise Program; Hospital-based Exercise
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Behavior; Skin and Connective Tissue Diseases; Breast Neoplasms; Motor Activity
• Other Study ID Numbers: Moving Together

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No