Clinical trial NCT02408133: Effectiveness of Home-based Exercise in Quality of Life and Physical Fitness in Older Woman in Breast Cancer Treatment
Official title: Effectiveness of Home-based Exercise in Quality of Life and Physical Fitness in Older Woman in Breast Cancer Treatment: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
elderly
quality of life
exercise
Lead sponsor: Professor Fernando Figueira Integral Medicine Institute
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2015-04-03
Enrollment: 75
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Variation in the performance of Lift and Sitting Test
timeFrame: Change from Baseline in Lift and Sitting Test and after 12 weeks
measure: Variation in the performance of Flexion forearm Test
timeFrame: Change from Baseline in Flexion forearm Test and after 12 weeks
measure: Variation in the performance of Six Minute Walk Test (6MWT)
timeFrame: Change from Baseline in Six Minute Walk Test (6MWT) and after 12 weeks
measure: Variation in the performance of March Stationary two minutes Test
timeFrame: Change from Baseline in March Stationary two minutes Test and after 12 weeks
measure: Variation in the performance of Skip and Vir 2.44 meters test
timeFrame: Change from Baseline in Skip and Vir 2.44 meters test and after 12 weeks
measure: Variation in the performance of Sit and Reach Modified test (In the Chair)
timeFrame: Change from Baseline in Sit and Reach Modified test (In the Chair) and after 12 weeks
measure: Variation in the performance of Flexibility test of the upper limbs
timeFrame: Change from Baseline in Flexibility test of the upper limbs and after 12 weeks
measure: Body Mass Index
timeFrame: Change from Baseline in Body Mass Index and after 12 weeks
measure: Variation in the performance of Muscle strength Test
timeFrame: Change from Baseline in Muscle strength Test after 12 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: Change from Baseline in Quality of life after 12 weeks
Other outcomes:
measure: Weight
timeFrame: Change from Baseline in Weight after 12 weeks
measure: Height
timeFrame: Change from Baseline in Height after 12 weeks
measure: Total Muscle Mass Index (IMMT)
timeFrame: Change from Baseline in Total Muscle Mass Index (IMMT) after 12 weeks
measure: Fat percentage
timeFrame: Change from Baseline in Fat percentage after 12 weeks
Locations:
Study officials:
affiliation: Instituto de Medicina Integral Prof. Fernando Figueira
name: João Guilherme Bezerra Alves, Doctor
role: STUDY_DIRECTOR
affiliation: Instituto de Medicina Integral Prof. Fernando Figueira
name: Breno Augusto Bormann de Souza Filho, Graduate
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Medicina Integral Prof. Fernando Figueira
name: José Roberto da Silva Junior, Master
role: STUDY_DIRECTOR
affiliation: Instituto de Medicina Integral Prof. Fernando Figueira
name: William Serrano Smethurst, Master
role: STUDY_DIRECTOR
affiliation: Instituto de Medicina Integral Prof. Fernando Figueira
name: JuremaTelles de Oliveira Lima, Master
role: STUDY_DIRECTOR
References: