Effects of Exercise Oncology Intervention in Fitness Capacity and Body Composition in Breast Cancer Survivals (WIM_22)

Tigers Running Club

Status: Completed

Conditions: Breast Cancer; Cancer Survivors

Treatments: Other: Active Physical Activities intervention; Other: Oncological physical exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05882578

WIM_SURVIVALS_22

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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).

Treatment:

Other: Oncological physical exercise intervention

Control Group

Active Comparator group

Description:

Patients will be asked to mantain an active lifestyle, performing physical activity regularly.

Treatment:

Other: Active Physical Activities intervention