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

NCT ID: NCT05882578

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-12

Study Completion Date

2023-07-31

Brief Summary

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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

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Conditions

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Breast Cancer Cancer Survivors

Keywords

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Breast Cancer Exercise Oncology Cancer Survivors Fitness Capacity Quality of life

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

control trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Doesn´t exist. Patients were allocated depending their preferences

Study Groups

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Intervention Group

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).

Group Type EXPERIMENTAL

Oncological physical exercise intervention

Intervention Type OTHER

An initial physical assestment where clinical history, body composition, functionality, cardiovascular fitness and quality of life will be tested.

Patients will be screened and then divided in diferent groups, depending on both their cardiovascular and physical capacity.

Then they will perform 2 sessions of combined strength and endurance training per week for 16 weeks.

At the end of the training program, the patients will be assesed to evaluate the changes in their cardiovascular fitness, functionality, body composition and quality of life.

Control Group

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

Group Type ACTIVE_COMPARATOR

Active Physical Activities intervention

Intervention Type OTHER

An initial physical assestment where clinical history, body composition, functionality, cardiovascular fitness and quality of life will be tested Patients will be suggested to mantain active physical activities in their daily life.

At the end of the training program, the patients will be assesed to evaluate the changes in their cardiovascular fitness, functionality, body composition and quality of life.

Interventions

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Oncological physical exercise intervention

An initial physical assestment where clinical history, body composition, functionality, cardiovascular fitness and quality of life will be tested.

Patients will be screened and then divided in diferent groups, depending on both their cardiovascular and physical capacity.

Then they will perform 2 sessions of combined strength and endurance training per week for 16 weeks.

At the end of the training program, the patients will be assesed to evaluate the changes in their cardiovascular fitness, functionality, body composition and quality of life.

Intervention Type OTHER

Active Physical Activities intervention

An initial physical assestment where clinical history, body composition, functionality, cardiovascular fitness and quality of life will be tested Patients will be suggested to mantain active physical activities in their daily life.

At the end of the training program, the patients will be assesed to evaluate the changes in their cardiovascular fitness, functionality, body composition and quality of life.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tigers Running Club

OTHER

Sponsor Role lead

Responsible Party

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Soraya Casla Barrio

Director of Oncologic Physical Exercise Area and PhD in Exercise Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Soraya Casla-Barrio, PhD

Role: PRINCIPAL_INVESTIGATOR

Tigers Running Club

Helios Pareja-Galeano, PhD

Role: STUDY_CHAIR

Universidad Autonoma de Madrid

Mónica Castellanos, MSc

Role: STUDY_CHAIR

Tigers Running Club

Jaime Pérez-Vélez, BSc

Role: STUDY_CHAIR

Tigers Running Club

Locations

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Tigers Running Club

Madrid, , Spain

Site Status

Countries

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Spain

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Related Links

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http://seom.org/seomcms/images/stories/recursos/Cifras_del_cancer_2020.pdf

Figures of cancer incidence, prevalence, mortality, survival and risk factors in Spain

Other Identifiers

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WIM_SURVIVALS_22

Identifier Type: -

Identifier Source: org_study_id