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OpenTrials
Completed

NCT Number: NCT03061773

Physical Training on Patients With Breast Cancer

The treatment of breast cancer at any given time can be through surgery, as well as adjuvant treatments (radiotherapy, chemotherapy and hormone therapy) alone or together. And with this the patient tends to lose weight, he becomes depressed, resulting in an increasingly debilitating picture. Therefore, the present study aims to investigate the relationship between physical exercise and its effects on quality of life in patients with breast cancer, those who underwent surgery for at least 6 months, patients who are still with the Tumor using the adjuvant treatments submitted to physical exercises and not submitted. The sample will consist of 25 to 50 female patients aged 18 to 75 years. Patients will be submitted to the initial quality of life evaluation (SF - 36 reduced version, Anxiety and depression (HAD Scale), Fatigue (Piper Fatigue Scale), Pain (Brief Inventory of Pain), Body Composition (Bioimpedance BYODINAMICS 450 ) And oxidative stress markers (oxidized and reduced glutathione, TBARS / MDA, Myeloperoxidase and Creatinine), inflammatory markers (IL1, IL6, IL8, IL10, MCP-1 and TNF-α), hormones Estrogen, progesterone), blood test (complete blood count) 24 hour food recall (24hs food recall), and perform the maximum repetition test to find the initial workload that will be adjusted every 4 weeks with the evaluation of the load and Completing the 12 weeks of training will be reevaluated following the initial evaluation. The data collected will be treated statistically with an α=5% using the software Stata 12.0.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

The patients will be allocated into two groups: exercise group (intervention) and conventional treatment group (active comparison). Intervention: The combined training program consisted of 12-week aerobic, resistive and flexibility exercises, with 3 sessions per week of aerobic and resistive training in the same session (supervised by physical exercise coaches) and 2 sessions per week of Flexibility training (unsupervised). As stretching sessions were interspersed with sessions of aerobic and weathered training in the daytime period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Breast cancer patients;
  • Sedentary;
  • Currently at treatment and clinical follow-up.

Exclusion criteria

  • Musculoskeletal injuries or disorders;
  • Mental illnesses;
  • Enrolled in other exercise program.

Treatment and study plan

Exercise

Other

Physical training: The combined training program consisted of 12-week aerobic, resistive and flexibility exercises, with 3 sessions per week of aerobic and resistive training in the same session (supervised by physical exercise coaches) and 2 sessions per week of Flexibility training (unsupervised). As stretching sessions were interspersed with sessions of aerobic and weathered training in the daytime period.

Other names: Physical exercise

Conventional hospital treatment

Behavioral

Conventional hospital treatment: The patients did not perform physical training

Primary outcomes

  1. Measure the pain, The Brief Pain Inventory (BPI).

    Time frame: 12 weeks

    Reduction of pain due to increased functional capacity

Secondary outcomes

  1. Measure the Fatigue; The revised piper fatigue scale (PFS-R).

    Time frame: 12 weeks

    Reduction of fatigue due to increased functional capacity

Sponsors and collaborators

Lead sponsor

Federal University of Maranhao

Other

Registry information

Official study title

Benefits of Physical Exercise in Patients With Breast Cancer

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 23, 2017
Registry last updated
Feb 23, 2017

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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