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Completed

NCT Number: NCT05882578

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cancer Survivors Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tigers Running Club

Madrid, 28009, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oncological physical exercise intervention

Other

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

Other

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 outcomes

  1. 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

  1. Body composition

    Time frame: 16 weeks

    Analyze the effect of the oncologic 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 breast cancer survivors.

  2. Physical functionality

    Time frame: 16 weeks

    Know the impact of the oncologic physical exercise program in the physical functionality of the patients.

  3. Exercise adherence

    Time frame: 16 weeks

    Measure the level of adherence to the oncologic physical exercise program, registering the assistance to the sessions.

  4. Physical activity Levels

    Time frame: 16 weeks

    Evaluate the effect of the intervention in the physical activity levels performed by the patients.

  5. Fatigue levels

    Time frame: 16weeks

    Evaluate the impact of the physical exercise program in the fatigue levels of the participants.

  6. Quality of life and health

    Time frame: 16 weeks

    Evaluate the impact of the oncological physical exercise program in the quality of life of the patients in relation with their health.

  7. Anxiety and depression levels

    Time frame: 16 weeks

    Analyze the impact of the oncologic physical exercise program in the anxiety and depression levels of the subjects.

Sponsors and collaborators

Lead sponsor

Tigers Running Club

Other

Registry information

Acronym: WIM_22

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 31, 2023
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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