Breast CancerNCT02408133
Effectiveness of Home-based Exercise in Quality of Life and Physical Fitness in Older Woman in Breast Cancer Treatment
A study testing Home exercise in people with Breast Cancer, run by Professor Fernando Figueira Integral Medicine Institute.
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. Read more about this study
- Who is it for?
- Ages 60 to 74 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Home exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer diagnosis with stage I or II;
- Being in treatment for breast cancer (chemotherapy; radiotherapy and / or hormone therapy).
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Home exercise
- Keywords
- Breast Cancer, elderly, quality of life, exercise
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home exerciseOther
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will be accompanied according to the service routine. |
| Exercise | Experimental | The group will be instructed to perform home exercises autonomously for range of motion and muscular fitness Receives: Other: Home exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline in Lift and Sitting Test and after 12 weeks
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.
Measured: Change from Baseline in Flexion forearm Test and after 12 weeks
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.
Measured: Change from Baseline in Six Minute Walk Test (6MWT) and after 12 weeks
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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
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.
Measured: Change from Baseline in Flexibility test of the upper limbs and after 12 weeks
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
Measured: Change from Baseline in Body Mass Index and after 12 weeks
Variation in the performance of Muscle strength Test
Hand Grip Strength Test. Continuous numeric variable: average kilogram-force (KgF)
Measured: Change from Baseline in Muscle strength Test after 12 weeks
Secondary outcomes (1)
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)
Measured: Change from Baseline in Quality of life after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startFeb 2016
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Fernando Figueira Integral Medicine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Responsible party
- Principal investigator, José Roberto da Silva Junior, Professor Fernando Figueira Integral Medicine Institute
- Investigators
- João Guilherme Bezerra Alves, Doctor, Study director, Instituto de Medicina Integral Prof. Fernando FigueiraBreno Augusto Bormann de Souza Filho, Graduate, Principal investigator, Instituto de Medicina Integral Prof. Fernando FigueiraJosé Roberto da Silva Junior, Master, Study director, Instituto de Medicina Integral Prof. Fernando FigueiraWilliam Serrano Smethurst, Master, Study director, Instituto de Medicina Integral Prof. Fernando FigueiraJuremaTelles de Oliveira Lima, Master, Study director, Instituto de Medicina Integral Prof. Fernando Figueira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408133
- Sponsor's protocol ID
- U1111-1165-5043
- Status last verified
- Sep 2016
- First submitted
- 24 Feb 2015
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Home-based Exercise in Quality of Life and Physical Fitness in Older Woman in Breast Cancer Treatment: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02408133
- Acronym / sponsor ID
- U1111-1165-5043
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, elderly, quality of life, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Professor Fernando Figueira Integral Medicine InstituteUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Study start
- Feb 2016
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will be accompanied according to the service routine. |
| Exercise | Experimental | Other: Home exerciseThe group will be instructed to perform home exercises autonomously for range of motion and muscular fitness |
Who may qualify
- Ages
- 60 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Breast cancer diagnosis with stage I or II;
- Being in treatment for breast cancer (chemotherapy; radiotherapy and / or hormone therapy).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home exerciseAlso: ExerciseWill 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 | Exercise |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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
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)
1 secondary outcome
Quality of life
Time frame: Change from Baseline in Quality of life after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
João Guilherme Bezerra Alves, Doctor study director
Instituto de Medicina Integral Prof. Fernando Figueira
Breno Augusto Bormann de Souza Filho, Graduate principal investigator
Instituto de Medicina Integral Prof. Fernando Figueira
José Roberto da Silva Junior, Master study director
Instituto de Medicina Integral Prof. Fernando Figueira
Questions about this trial
What is this clinical trial studying?
A study testing Home exercise in people with Breast Cancer, run by Professor Fernando Figueira Integral Medicine Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in the performance of Lift and Sitting Test (time frame: Change from Baseline in Lift and Sitting Test and after 12 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016.