Clinical trial NCT05882578: Effects of Exercise Oncology Intervention in Fitness Capacity and Body Composition in Breast Cancer Survivals
Official title: Effects of Exercise Oncology Intervention in Fitness Capacity and Body Composition in Breast Cancer Survivals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cancer Survivors
Keywords: Breast Cancer
Exercise Oncology
Cancer Survivors
Fitness Capacity
Quality of life
Lead sponsor: Tigers Running Club
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: control trial
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cardiovascular fitness
timeFrame: 16 weeks
Secondary outcomes:
measure: Body composition
timeFrame: 16 weeks
measure: Physical functionality
timeFrame: 16 weeks
measure: Exercise adherence
timeFrame: 16 weeks
measure: Physical activity Levels
timeFrame: 16 weeks
measure: Fatigue levels
timeFrame: 16weeks
measure: Quality of life and health
timeFrame: 16 weeks
measure: Anxiety and depression levels
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Tigers Running Club
Study officials:
affiliation: Tigers Running Club
name: Soraya Casla-Barrio, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Autonoma de Madrid
name: Helios Pareja-Galeano, PhD
role: STUDY_CHAIR
affiliation: Tigers Running Club
name: Mónica Castellanos, MSc
role: STUDY_CHAIR
affiliation: Tigers Running Club
name: Jaime Pérez-Vélez, BSc
role: STUDY_CHAIR
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