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Effectiveness of Home-based Exercise in Quality of Life and Physical Fitness in Older Woman in Breast Cancer Treatment

P

Professor Fernando Figueira Integral Medicine Institute

Status

Completed

Conditions

Breast Cancer

Treatments

Other: Home exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT02408133
U1111-1165-5043

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of home exercise on quality of life and physical fitness of elderly women with breast cancer patients undergoing cancer treatment.

Full description

Cancer has excelled as a leading cause of mortality. It is particularly serious in the elderly due to increased risk of functional impairment and present comorbidities. The physical exercise appears as a promising intervention in the various stages of the treatment, mitigating the adverse effects in short- and long-term the oncologic treatment. Its regular practice after a diagnosis of breast cancer is associated with 40 % to 50 % lower rates of mortality. Produces metabolic and morphological changes that may make it an important option in the treatment, prevention, and recovery process of these patients. In this context the present study aims to verify the effectiveness of home exercise on quality of life and physical fitness of elderly undergoing treatment for breast cancer. This study it's a Randomized Clinical Trial. Data will be collected at the Department of Oncology at the Professor Fernando Figueira Integral Medicine Institute (IMIP), which serves patients in the public health system (SUS) from the metropolitan area of Recife, State of Pernambuco. will be held from March to December 2015. Will be studied elderly diagnosed with breast cancer undergoing treatment in the Adult Oncology Service of IMIP. For the analysis of means and frequencies, the investigators intend to use descriptive statistics and the results will be displayed in graphs and tables. For inferential statistical analysis, the investigators intend to use the Student's t test, or the Mann - Whitney test, according to the normality of the sample. For categorical variables, contingency tables are constructed of type 2x2. Chi-square tests of association with Yates correction and Fisher's exact test will be used. The risk ratio (RR) will be calculated as a measure of the relative risk of different outcomes according to the realization of one or another approach to exercise and control group. The Software Stata 12.0 will be used for data processing and will be accepted at p < 0,05. The project meets the requirements of the National Board of Health and was approved by the IMIP Research Ethics Committee. Patients who agree to sign the Instrument of Consent will be included in the study.

Enrollment

75 patients

Sex

Female

Ages

60 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Breast cancer diagnosis with stage I or II;
  • Being in treatment for breast cancer (chemotherapy; radiotherapy and / or hormone therapy).

Exclusion criteria

  • Absolute contraindication for physical exercises;
  • Severe depression diagnosis using the Geriatric Depression Scale;
  • Malnutrition (wasting grades I, II and III), detected by body mass index (BMI), according to the WHO criteria.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 2 patient groups

Control
No Intervention group
Description:
The control group will be accompanied according to the service routine.
Exercise
Experimental group
Description:
The group will be instructed to perform home exercises autonomously for range of motion and muscular fitness
Treatment:
Other: Home exercise

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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