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Trial Title:
Effects of Exercise Oncology Intervention in Fitness Capacity and Body Composition in Breast Cancer Survivals
NCT ID:
NCT05882578
Condition:
Breast Cancer
Exercise Oncology
Cancer Survivors
Fitness Capacity
Conditions: Official terms:
Breast Neoplasms
Neoplasms
Conditions: Keywords:
Breast Cancer
Exercise Oncology
Cancer Survivors
Fitness Capacity
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
control trial
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Masking description:
Doesn´t exist. Patients were allocated depending their preferences
Intervention:
Intervention type:
Other
Intervention name:
Oncological physical exercise 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.
Arm group label:
Intervention Group
Intervention type:
Other
Intervention name:
Active Physical Activities 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.
Arm group label:
Control Group
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Tigers Running Club
Address:
City:
Madrid
Zip:
28009
Country:
Spain
Start date:
January 12, 2023
Completion date:
July 31, 2023
Lead sponsor:
Agency:
Tigers Running Club
Agency class:
Other
Source:
Tigers Running Club
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05882578
http://seom.org/seomcms/images/stories/recursos/Cifras_del_cancer_2020.pdf
