Physical Training on Patients With Breast Cancer

NCT ID: NCT03061773

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-01
• Study Completion Date: 2015-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

Breast Cancer Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise group

Exercise group: physical training lasting 12 weeks, after detraining and in the end the control group receives physical training

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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.

Group did not exercise

Group did not exercise: conventional hospital treatment

Group Type: ACTIVE_COMPARATOR

Conventional hospital treatment

Intervention Type: BEHAVIORAL

Conventional hospital treatment: The patients did not perform physical training

Interventions

Exercise

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.

Intervention Type: OTHER

Conventional hospital treatment

Conventional hospital treatment: The patients did not perform physical training

Intervention Type: BEHAVIORAL

Other Intervention Names

Physical exercise

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Maranhao

OTHER

Sponsor Role: lead

Responsible Party

Andréa Dias Reis

Msc. Adult and Child Health and Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

JOÃO BS GARCIA, Doctor

Role: STUDY_DIRECTOR

Federal University of Maranhão

References

Backman M, Wengstrom Y, Johansson B, Skoldengen I, Borjesson S, Tarnbro S, Berglund A. A randomized pilot study with daily walking during adjuvant chemotherapy for patients with breast and colorectal cancer. Acta Oncol. 2014 Apr;53(4):510-20. doi: 10.3109/0284186X.2013.873820. Epub 2014 Jan 24.

Reference Type: BACKGROUND

PMID: 24460069 (View on PubMed)

Do J, Cho Y, Jeon J. Effects of a 4-week multimodal rehabilitation program on quality of life, cardiopulmonary function, and fatigue in breast cancer patients. J Breast Cancer. 2015 Mar;18(1):87-96. doi: 10.4048/jbc.2015.18.1.87. Epub 2015 Mar 27.

Reference Type: BACKGROUND

PMID: 25834616 (View on PubMed)

Nyrop KA, Callahan LF, Rini C, Altpeter M, Hackney B, Schecher A, Wilson A, Muss HB. Adaptation of an Evidence-Based Arthritis Program for Breast Cancer Survivors on Aromatase Inhibitor Therapy Who Experience Joint Pain. Prev Chronic Dis. 2015 Jun 11;12:E91. doi: 10.5888/pcd12.140535.

Reference Type: BACKGROUND

PMID: 26068412 (View on PubMed)

Sullivan AB, Scheman J, Venesy D, Davin S. The role of exercise and types of exercise in the rehabilitation of chronic pain: specific or nonspecific benefits. Curr Pain Headache Rep. 2012 Apr;16(2):153-61. doi: 10.1007/s11916-012-0245-3.

Reference Type: BACKGROUND

PMID: 22258395 (View on PubMed)

Travier N, Velthuis MJ, Steins Bisschop CN, van den Buijs B, Monninkhof EM, Backx F, Los M, Erdkamp F, Bloemendal HJ, Rodenhuis C, de Roos MA, Verhaar M, ten Bokkel Huinink D, van der Wall E, Peeters PH, May AM. Effects of an 18-week exercise programme started early during breast cancer treatment: a randomised controlled trial. BMC Med. 2015 Jun 8;13:121. doi: 10.1186/s12916-015-0362-z.

Reference Type: BACKGROUND

PMID: 26050790 (View on PubMed)

Reis AD, Pereira PTVT, Diniz RR, de Castro Filha JGL, Dos Santos AM, Ramallo BT, Filho FAA, Navarro F, Garcia JBS. Effect of exercise on pain and functional capacity in breast cancer patients. Health Qual Life Outcomes. 2018 Apr 6;16(1):58. doi: 10.1186/s12955-018-0882-2.

Reference Type: DERIVED

PMID: 29625622 (View on PubMed)

Other Identifiers

FEDERAL UNIVERSITY OF MARANHAO

Identifier Type: -

Identifier Source: org_study_id