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

Breast Cancer Clinical Trial

— WIM_22  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05882578
• Other study ID #: WIM_SURVIVALS_22
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 12, 2023
• Est. completion date: July 31, 2023

Study information

• Verified date: May 2023
• Source: Tigers Running Club
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. completion date: July 31, 2023
• Est. primary completion date: April 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer Survivors
• Neoplasms

Intervention

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 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.

Locations

Country	Name	City	State
Spain	Tigers Running Club	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Tigers Running Club

Country where clinical trial is conducted

Spain, 

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	16 weeks
Secondary	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	16 weeks
Secondary	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.	16 weeks
Secondary	Exercise adherence	Meassure the level of adherence to the oncologic physical exercise program, registering the assistence to te sessions	16 weeks
Secondary	Exercise Level	Evaluate the effect of the intervention in the level of exercise performed by the patients, using the IPAQ cuesttionaire (short version)	16 weeks
Secondary	Fatigue levels	Evaluate the impact of the physical exercise program in the fatigue levels of the participants via the FACT-F questionnaire	16weeks
Secondary	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.	16 weeks
Secondary	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)	16 weeks

External Links

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