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

December 13, 2024 updated by: Soraya Casla Barrio, Tigers Running Club

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28009
        • Tigers Running Club

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Other: 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.
Active Comparator: Control Group
Patients will be asked to mantain an active lifestyle, performing physical activity regularly.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular fitness
Time Frame: 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.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: 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.
16 weeks
Physical functionality
Time Frame: 16 weeks
Know the impact of the oncologic physical exercise program in the physical functionality of the patients.
16 weeks
Exercise adherence
Time Frame: 16 weeks
Measure the level of adherence to the oncologic physical exercise program, registering the assistance to the sessions.
16 weeks
Physical activity Levels
Time Frame: 16 weeks
Evaluate the effect of the intervention in the physical activity levels performed by the patients.
16 weeks
Fatigue levels
Time Frame: 16weeks
Evaluate the impact of the physical exercise program in the fatigue levels of the participants.
16weeks
Quality of life and health
Time Frame: 16 weeks
Evaluate the impact of the oncological physical exercise program in the quality of life of the patients in relation with their health.
16 weeks
Anxiety and depression levels
Time Frame: 16 weeks
Analyze the impact of the oncologic physical exercise program in the anxiety and depression levels of the subjects.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tigers Running Club

Investigators

  • Principal Investigator: Soraya Casla-Barrio, PhD, Tigers Running Club
  • Study Chair: Helios Pareja-Galeano, PhD, Universidad Autonoma de Madrid
  • Study Chair: Mónica Castellanos, MSc, Tigers Running Club
  • Study Chair: Jaime Pérez-Vélez, BSc, Tigers Running Club

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2023

Primary Completion (Actual)

April 9, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 13, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WIM_SURVIVALS_22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The information will be shared with the patients after the completion of every test.

This information will be shared only with the participant researchers of this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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