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

September 28, 2016 updated by: José Roberto da Silva Junior, Professor Fernando Figueira Integral Medicine Institute

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
The control group will be accompanied according to the service routine.
Experimental: Exercise
The group will be instructed to perform home exercises autonomously for range of motion and muscular fitness
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.
Other Names:
  • Exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Variation in the performance of Lift and Sitting Test
Time Frame: Change from Baseline in Lift and Sitting Test and after 12 weeks
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
Variation in the performance of Flexion forearm Test
Time Frame: Change from Baseline in Flexion forearm Test and after 12 weeks
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
Variation in the performance of Six Minute Walk Test (6MWT)
Time Frame: Change from Baseline in Six Minute Walk Test (6MWT) and after 12 weeks
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
Variation in the performance of March Stationary two minutes Test
Time Frame: Change from Baseline in March Stationary two minutes Test and after 12 weeks
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
Variation in the performance of Skip and Vir 2.44 meters test
Time Frame: Change from Baseline in Skip and Vir 2.44 meters test and after 12 weeks
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
Variation in the performance of Sit and Reach Modified test (In the Chair)
Time Frame: Change from Baseline in Sit and Reach Modified test (In the Chair) and after 12 weeks
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
Variation in the performance of Flexibility test of the upper limbs
Time Frame: Change from Baseline in Flexibility test of the upper limbs and after 12 weeks
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
Body Mass Index
Time Frame: Change from Baseline in Body Mass Index and after 12 weeks
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
Variation in the performance of Muscle strength Test
Time Frame: Change from Baseline in Muscle strength Test after 12 weeks
Hand Grip Strength Test. Continuous numeric variable: average kilogram-force (KgF)
Change from Baseline in Muscle strength Test after 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: Change from Baseline in Quality of life after 12 weeks
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: Change from Baseline in Weight after 12 weeks
Measurement of body mass, using electronic scale Tanita®. Characterized as continuous numerical variable, measured in kilograms
Change from Baseline in Weight after 12 weeks
Height
Time Frame: Change from Baseline in Height after 12 weeks
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
Total Muscle Mass Index (IMMT)
Time Frame: Change from Baseline in Total Muscle Mass Index (IMMT) after 12 weeks
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
Fat percentage
Time Frame: Change from Baseline in Fat percentage after 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Professor Fernando Figueira Integral Medicine Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, Brazil

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: João Guilherme Bezerra Alves, Doctor, Instituto de Medicina Integral Prof. Fernando Figueira
  • Principal Investigator: Breno Augusto Bormann de Souza Filho, Graduate, Instituto de Medicina Integral Prof. Fernando Figueira
  • Study Director: José Roberto da Silva Junior, Master, Instituto de Medicina Integral Prof. Fernando Figueira
  • Study Director: William Serrano Smethurst, Master, Instituto de Medicina Integral Prof. Fernando Figueira
  • Study Director: JuremaTelles de Oliveira Lima, Master, Instituto de Medicina Integral Prof. Fernando Figueira

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • U1111-1165-5043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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