Effects of Exercise Oncology Intervention in Fitness Capacity and Body Composition in Breast Cancer Survivals

Not Applicable

Completed

• Conditions: Breast Cancer; Cancer Survivors
• Interventions: Other: Oncological physical exercise intervention; Other: Active Physical Activities intervention

• Registration Number: NCT05882578
• Lead Sponsor: Tigers Running Club

Brief Summary

The goal of this interventional study is to analyze the impact of a supervised oncological exercise intervention in surviving breast cancer patients. The main questions it aims to answer are:

* Evaluate the efectivity of a supervised individualized and adapted oncological physical exercise program in the cardiovascular fitness of the participants.

* Analyze the impact of this intervention in the body composition, functionality and quality of life of the parcitipants

Participants will perform a controlled and adapted program, supervised by an especialized professional during 16 weeks.

Researchers will compare this intervention group, where the supervised program will take place, with a control group, where the patients will perform regular physical activity (non-supervised) to see the changes in the efectivity and impact in cardiovascular fitness, body composition and quality of life.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-12
• Primary Completion: 2023-04-09
• Study First Submitted: 2023-05-22
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-05-31
• Study Completion: 2023-07-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

Inclusion Criteria

• Women diagnosed with primary, type I to III A/B cancer, with hormonal positive (ER+ and PG+), triple positive (ER+, PG+ y HER2+) or triple negative subtype.
• Women with chemotherapy and radiotherapy phase complete.
• Women with post-surgery phase complete.
• Women that are within 5 years from diagnostic.
• ECOG Score above or equal to 0 or 1.

Exclusion Criteria

• Submit medical contraindications to physical exercise by their reference doctor.
• Women in state IV o methastasis.
• Pregnant women.
• Meet any of the criteria of the American Thoracic Society (ATS) to perfrom a cardiovascular fitness test.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Oncological physical exercise intervention	Patients will be assessed and screened prior the intervention. After the physical assestment they will attend 2 days a week for the supervised, and controlled sessions of physical exercise, performed in the nature (Retiro park in Madrid). To meassure the intensity of the program, they will use the 1-10 Borg ratio of perceived exertion (RPE).
Control Group	Active Physical Activities intervention	Patients will be asked to mantain an active lifestyle, performing physical activity regularly.

Primary Outcome Measures

Name	Time	Method
Cardiovascular fitness	16 weeks	Evaluate the effectiveness of the program in the improvement of the cardiovascular capacity in breast cancer survivors (looking for a difference of 3,49 ml/kg/min of oxigen consumption), using a submaximal cardiovascular test.

Secondary Outcome Measures

Name	Time	Method
Fatigue levels	16weeks	Evaluate the impact of the physical exercise program in the fatigue levels of the participants.
Body composition	16 weeks	Analyze the effect of the oncologic physical exercise program in the body weight, the body mass index (BMI), percentages in body fat, abdominal fat, fat free mass, bone mass and total body water in breast cancer survivors.
Physical functionality	16 weeks	Know the impact of the oncologic physical exercise program in the physical functionality of the patients.
Exercise adherence	16 weeks	Measure the level of adherence to the oncologic physical exercise program, registering the assistance to the sessions.
Physical activity Levels	16 weeks	Evaluate the effect of the intervention in the physical activity levels performed by the patients.
Quality of life and health	16 weeks	Evaluate the impact of the oncological physical exercise program in the quality of life of the patients in relation with their health.
Anxiety and depression levels	16 weeks	Analyze the impact of the oncologic physical exercise program in the anxiety and depression levels of the subjects.

Trial Locations

Locations (1)

Tigers Running Club; 🇪🇸 Madrid, Spain