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

Primary Purpose

Breast Cancer, Exercise Oncology, Cancer Survivors

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Oncological physical exercise intervention
Active Physical Activities intervention
Sponsored by
Tigers Running Club
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Exercise Oncology, Cancer Survivors, Fitness Capacity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

  • Tigers Running Club

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm 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).

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

Outcomes

Primary Outcome Measures

Cardiovascular fitness improvement
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

Effects in Body composition
Analyze the effect of the 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 patinets that surviuve breast cancer via bioimpedancy
Physical functionality
Know the impact of the oncologic physical exercise program in the physical functionality of the patients, using the 6 minutes walk test and the 30 seconds sit and stand test.
Exercise adherence
Meassure the level of adherence to the oncologic physical exercise program, registering the assistence to te sessions
Exercise Level
Evaluate the effect of the intervention in the level of exercise performed by the patients, using the IPAQ cuesttionaire (short version)
Fatigue levels
Evaluate the impact of the physical exercise program in the fatigue levels of the participants via the FACT-F questionnaire
Quality of life and health
Evaluate the impact of the oncologilcal physical exercise program in the quality of life of the patients in relation with their heath, usint the EQ5D questionnaire.
Anxiety and depression levels
Evaluate the impact of the physical oncologic program in the anxiety and depression levels of the subjects using the Hospitalary Anxiety and Depression Scale (HADS)

Full Information

First Posted
May 22, 2023
Last Updated
May 22, 2023
Sponsor
Tigers Running Club
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1. Study Identification

Unique Protocol Identification Number
NCT05882578
Brief Title
Effects of Exercise Oncology Intervention in Fitness Capacity and Body Composition in Breast Cancer Survivals
Acronym
WIM_22
Official Title
Effects of Exercise Oncology Intervention in Fitness Capacity and Body Composition in Breast Cancer Survivals
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
April 9, 2023 (Actual)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tigers Running Club

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Exercise Oncology, Cancer Survivors, Fitness Capacity
Keywords
Breast Cancer, Exercise Oncology, Cancer Survivors, Fitness Capacity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
control trial
Masking
None (Open Label)
Masking Description
Doesn´t exist. Patients were allocated depending their preferences
Allocation
Non-Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm 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).
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patients will be asked to mantain an active lifestyle, performing physical activity regularly.
Intervention Type
Other
Intervention Name(s)
Oncological physical exercise intervention
Intervention Description
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
Intervention Name(s)
Active Physical Activities intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiovascular fitness improvement
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Effects in Body composition
Description
Analyze the effect of the 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 patinets that surviuve breast cancer via bioimpedancy
Time Frame
16 weeks
Title
Physical functionality
Description
Know the impact of the oncologic physical exercise program in the physical functionality of the patients, using the 6 minutes walk test and the 30 seconds sit and stand test.
Time Frame
16 weeks
Title
Exercise adherence
Description
Meassure the level of adherence to the oncologic physical exercise program, registering the assistence to te sessions
Time Frame
16 weeks
Title
Exercise Level
Description
Evaluate the effect of the intervention in the level of exercise performed by the patients, using the IPAQ cuesttionaire (short version)
Time Frame
16 weeks
Title
Fatigue levels
Description
Evaluate the impact of the physical exercise program in the fatigue levels of the participants via the FACT-F questionnaire
Time Frame
16weeks
Title
Quality of life and health
Description
Evaluate the impact of the oncologilcal physical exercise program in the quality of life of the patients in relation with their heath, usint the EQ5D questionnaire.
Time Frame
16 weeks
Title
Anxiety and depression levels
Description
Evaluate the impact of the physical oncologic program in the anxiety and depression levels of the subjects using the Hospitalary Anxiety and Depression Scale (HADS)
Time Frame
16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soraya Casla-Barrio, PhD
Organizational Affiliation
Tigers Running Club
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helios Pareja-Galeano, PhD
Organizational Affiliation
Universidad Autonoma de Madrid
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mónica Castellanos, MSc
Organizational Affiliation
Tigers Running Club
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jaime Pérez-Vélez, BSc
Organizational Affiliation
Tigers Running Club
Official's Role
Study Chair
Facility Information:
Facility Name
Tigers Running Club
City
Madrid
ZIP/Postal Code
28009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
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Links:
URL
http://seom.org/seomcms/images/stories/recursos/Cifras_del_cancer_2020.pdf
Description
Figures of cancer incidence, prevalence, mortality, survival and risk factors in Spain

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

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