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

Sponsor

Tigers Running Club (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05882578

Collaborator

(none)

Enrollment

Location

Arms

6.6

Anticipated Duration (Months)

11.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Exercise Oncology Cancer Survivors Fitness Capacity	Other: Oncological physical exercise intervention Other: Active Physical Activities intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

control trialcontrol trial

Masking:

None (Open Label)

Masking Description:

Doesn´t exist. Patients were allocated depending their preferences

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 12, 2023

Actual Primary Completion Date :

Apr 9, 2023

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Cardiovascular fitness improvement [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.

Secondary Outcome Measures

Effects in Body composition [16 weeks]
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 [16 weeks]
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 [16 weeks]
Meassure the level of adherence to the oncologic physical exercise program, registering the assistence to te sessions
Exercise Level [16 weeks]
Evaluate the effect of the intervention in the level of exercise performed by the patients, using the IPAQ cuesttionaire (short version)
Fatigue levels [16weeks]
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 [16 weeks]
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 [16 weeks]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.