Evaluation of the Effect of Regular Physical Exercise in Breast Cancer.

NCT07893327 | Recruiting

• 2 other identifiers: IALIBIRD-CM1TEC-2024/BIO-281
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study, titled "Evaluation of the effect of regular physical exercise in women with breast cancer on adjuvant hormone therapy," is a research project designed to see how guided exercise can help women recovering from breast cancer. Here is a simple summary of the study: Who is it for? The study includes 150 women who have finished their primary treatments (like surgery or chemotherapy) and are in the early stages of hormone therapy. The Goal: Researchers want to understand how regular exercise improves quality of life, physical fitness, and nutrition. They are also studying how exercise affects the immune system and the gut microbiota (the healthy bacteria in your body). The Exercise Program: Participants take part in a 16-week supervised program. It consists of two sessions per week: one in a gym and one in a swimming pool. These sessions are led by experts and are specifically adapted to each patient's physical condition and needs. Using Technology: To help with the study, participants use a mobile app (IALIBIRD) and a wearable activity tracker (like a bracelet). These tools monitor daily steps, sleep quality, and heart rate, and allow patients to report how they feel. Medical Check-ups: Throughout the study, patients have regular visits to the hospital for blood tests and to provide saliva and stool samples for biological analysis. They also have body scans (DXA) to measure bone health, muscle mass, and body fat. Why is this important? While hormone therapy is a vital treatment, it can last for 5 to 10 years and cause side effects like extreme tiredness, joint pain, and anxiety. This study aims to prove that regular exercise is a safe and effective way to reduce these symptoms and help women feel better during their recovery.

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Keywords

breast cancer; physical activity

Outcome Measures

Primary Outcomes (1)

• Health-Related Quality of Life

  Evaluate the effect of a regular physical exercise intervention compared with standard care on health-related quality of life in patients with breast cancer using EORTC QLQ-BR42 questionnaires.

  through study completion, an average of 1 year

Secondary Outcomes (17)

• Change in physical activity level asseseed by IPAQ.

  through study completion, an average of 1 year

• Bioelectrical impedance analysis (BIA).

  through study completion, an average of 1 year

• Change in Mediterranean Diet Adherence Screener (MEDAS) score

  through study completion, an average of 1 year

• Change in dietary intake

  through study completion, an average of 1 year

• Change in sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI).

  through study completion, an average of 1 year

Study Arms (1)

Experimental

EXPERIMENTAL

The experimental arm consists of a 16-week supervised exercise program for women with Stage I-III breast cancer receiving hormone therapy. Participants perform two weekly sessions (one gym, one pool) at the Dehesa Boyal Sports Center, led by specialists. The intervention progresses through four monthly phases: adaptation, base building, moderate progression, and consolidation. Intensity is tailored using the Borg Scale and heart rate monitors. A central component is the IALIBIRD-CM digital platform, where patients use an app and wearables to track activity, sleep, and symptoms. Monitoring includes DXA scans for body composition and regular collection of blood, saliva, urine and stool samples. These help researchers analyze changes in the gut microbiota, immune markers, and genetics to understand how exercise improves quality of life and mitigates treatment side effects

Other: Supervised exercise program

Interventions

Supervised exercise program OTHER

6-week supervised exercise program for women with Stage I-III breast cancer receiving hormone therapy. Participants perform two weekly sessions (one gym, one pool) at the Dehesa Boyal Sports Center, led by specialists. The intervention progresses through four monthly phases: adaptation, base building, moderate progression, and consolidation. Intensity is tailored using the Borg Scale and heart rate monitors. A central component is the IALIBIRD-CM digital platform, where patients use an app and wearables to track activity, sleep, and symptoms.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To participate in the study, subjects must meet all of the following requirements:
• Age and Diagnosis: Women over 18 years old diagnosed with Stage I, II, or III invasive breast carcinoma.
• Treatment Status: Must have completed primary oncological treatment (surgery, chemotherapy, and/or radiotherapy) and be within the first three months of starting adjuvant hormone therapy (tamoxifen or aromatase inhibitors).
• Physical Condition: A good general health status, defined as an ECOG performance status of 0-2, and the functional ability to perform supervised moderate physical exercise.
• Technical Requirements: Access to the internet and the ability to use the mobile application required for study evaluations.
• Consent: Voluntary agreement to participate, confirmed by a signed written informed consent form.

You may not qualify if:

• Patients will be excluded from the study if they meet any of the following conditions:
• Prior Exercise Habits: Having performed regular physical exercise (one hour or more per week) during the last six months.
• Limiting Symptoms: Presence of symptoms such as fever, chest pain, dizziness, blurred vision, or vomiting that would limit exercise.
• Clinical Parameters: Analytical lab results showing hemoglobin below 10 g/dL or a platelet count below 50,000.
• Medical Pathologies: Uncontrolled arrhythmias, heart failure, recent head trauma (within the last month), untreated osteoporosis, COPD, or cognitive impairment, among other contraindicating conditions.
• Oncological Status: Distant metastases or an active oncological disease other than breast cancer.
• Medications and Supplements: Currently taking or having taken antibiotics or probiotic supplements within the last 1.5 months.
• Other Factors: Pregnancy, breastfeeding, travel difficulties, or any inability to comply with the required technological follow-up.
• The selection process is prospective, aiming to recruit a total of 150 patients over three phases (50 patients per year). Participants who meet all criteria but do not wish to follow the exercise program may be assigned to the control group.

Sponsors & Collaborators

• Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares: lead
• IMDEA Food: collaborator
• Fundación General CSIC: collaborator
• Universidad Politecnica de Madrid: collaborator

Study Sites (1)

Infanta Sofía University Hospital

San Sebastián de los Reyes, Madrid, 28702, Spain

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: October 23, 2026
• Study Start: January 17, 2026
• Primary Completion: October 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 23, 2026

Record last verified: 2026-10

Locations

ES (1)