Skip to main content
Clinical Trials/NCT05882578
NCT05882578
Completed
Not Applicable

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

Tigers Running Club1 site in 1 country74 target enrollmentJanuary 12, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Tigers Running Club
Enrollment
74
Locations
1
Primary Endpoint
Cardiovascular fitness
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 12, 2023
End Date
July 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Tigers Running Club
Responsible Party
Principal Investigator
Principal Investigator

Soraya Casla Barrio

Director of Oncologic Physical Exercise Area and PhD in Exercise Psychology

Tigers Running Club

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Body composition(16 weeks)
  • Physical functionality(16 weeks)
  • Exercise adherence(16 weeks)
  • Physical activity Levels(16 weeks)
  • Fatigue levels(16weeks)
  • Quality of life and health(16 weeks)
  • Anxiety and depression levels(16 weeks)

Study Sites (1)

Loading locations...

Similar Trials