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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02408133
• Other study ID #: U1111-1165-5043
• Status: Completed
• Phase: N/A
• First received: February 24, 2015
• Last updated: September 28, 2016
• Start date: February 2016
• Est. completion date: February 2016

Study information

• Verified date: September 2016
• Source: Professor Fernando Figueira Integral Medicine Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years to 74 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Home exercise
Will be offered to the group, instructional material (manual exercises) and point you to an exercise routine to be performed independently for range of motion and muscular fitness, using the environmental resources of the same household. A daily frequency in performing this exercise routine is suggested. Also, be given incentives and guidelines for the practice of active commuting (walking) to be accumulated at least 10 to 20 minutes of this activity daily. All control guidelines and training for the use of the exercise manual will be offered through an introductory lecture and subsequent weekly telephone contacts (2 times a week). The participants in this group should fulfill their respective program for a total period of 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Professor Fernando Figueira Integral Medicine Institute	Ministry of Health, Brazil

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight	Measurement of body mass, using electronic scale Tanita®. Characterized as continuous numerical variable, measured in kilograms	Change from Baseline in Weight after 12 weeks	No
Other	Height	Greater distance between the vertex and the ground when the individual in the standing position, using the stadiometer Sanny® brand. Characterized as continuous numeric variable measured in meters	Change from Baseline in Height after 12 weeks	No
Other	Total Muscle Mass Index (IMMT)	Measure of muscle mass relative amount contained in the body, through perimetry using anthropometric tape Sanny® brand. Characterized as continuous numeric variable.	Change from Baseline in Total Muscle Mass Index (IMMT) after 12 weeks	No
Other	Fat percentage	as the relative amount of fat contained in the body by means of perimetry using anthropometric Sanny® tape mark. Characterized as continuous numeric variable.	Change from Baseline in Fat percentage after 12 weeks	No
Primary	Variation in the performance of Lift and Sitting Test	Test which comprises the Battery Senior Fitness Test (SFT). Evaluates the Lower body strength according to the number of times the individual stood up and sat down in 30 seconds. Characterized as continuous numeric variable.	Change from Baseline in Lift and Sitting Test and after 12 weeks	No
Primary	Variation in the performance of Flexion forearm Test	Test which comprises the Battery Senior Fitness Test (SFT). Evaluates the upper body strength according to the number of push-ups of forearm in 30 seconds. Characterized as continuous numeric variable.	Change from Baseline in Flexion forearm Test and after 12 weeks	No
Primary	Variation in the performance of Six Minute Walk Test (6MWT)	Test which comprises the Battery Senior Fitness Test (SFT). Evaluates aerobic endurance. Total meters walked for 6 minutes walk. Characterized as continuous numeric variable.	Change from Baseline in Six Minute Walk Test (6MWT) and after 12 weeks	No
Primary	Variation in the performance of March Stationary two minutes Test	Test which comprises the Battery Senior Fitness Test (SFT). Evaluates aerobic endurance (alternative test). Total double past stationary in 2 minutes. Characterized as continuous numeric variable.	Change from Baseline in March Stationary two minutes Test and after 12 weeks	No
Primary	Variation in the performance of Skip and Vir 2.44 meters test	Test which comprises the Battery Senior Fitness Test (SFT). Assesses motor agility and dynamic balance. Evaluates the time in seconds and hundredths in an established path of 2.44 meters on the route to go and return to starting position. Characterized as continuous numerical variable.	Change from Baseline in Skip and Vir 2.44 meters test and after 12 weeks	No
Primary	Variation in the performance of Sit and Reach Modified test (In the Chair)	Test which comprises the Battery Senior Fitness Test (SFT). Evaluates the lower hemisphere flexibility. distance in centimeters reached the tip of the middle fingers and the floor in the sitting position. Characterized as continuous numerical variable.	Change from Baseline in Sit and Reach Modified test (In the Chair) and after 12 weeks	No
Primary	Variation in the performance of Flexibility test of the upper limbs	Test which comprises the Battery Senior Fitness Test (SFT). Evaluates the flexibility of the upper limbs. It measures the distance in centimeters between the tips of the fingers in the back area. Characterized as continuous numeric variable.	Change from Baseline in Flexibility test of the upper limbs and after 12 weeks	No
Primary	Body Mass Index	the calculation will be determined by the ratio between the weight (in kilograms) and the square of height (in meters). Characterized as continuous numeric variable	Change from Baseline in Body Mass Index and after 12 weeks	No
Primary	Variation in the performance of Muscle strength Test	Hand Grip Strength Test. Continuous numeric variable: average kilogram-force (KgF)	Change from Baseline in Muscle strength Test after 12 weeks	No
Secondary	Quality of life	Numeric variable: average score from 0 to 100 for 30 issues of questionnaire developed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)	Change from Baseline in Quality of life after 12 weeks	No