Physical Exercise in the Quality of Life and Physical Fitness of Elderly Women With Breast Cancer
Condition: Breast Cancer; Physical Activity; Physical Fitness; Quality of Life
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Among the possibilities of intervention to minimize the effects of cancer treatment, the
      exercises are efficient in improving the physical fitness and quality of life of the elderly
      in treatment. The goal is to compare the effects of two home physical exercise protocols on
      quality of life and physical fitness of elderly people with breast cancer who are in hormone
      use. A study was carried out at the Institute of Integral Medicine Professor Fernando
      Figueira (IMIP) within the Professional Master Program in Palliative Care Associated with the
      Residency Program in Health, which evaluated the effectiveness of a protocol of 29 exercises
      with walking sessions, performed at home , In the quality of life and physical fitness of the
      elderly in the treatment of breast cancer. The results of the mentioned research showed that
      the elderly showed improvement both in quality of life and physical fitness.

      In view of the results and the clinical and functional kinetic observation of these patients,
      the hypothesis was that a shorter intervention protocol, with fewer exercises with fewer
      repetitions and a lower degree of difficulty can bring results similar to those found,
      requiring a shorter time In the accomplishment of the exercises, which can favor the
      adherence to the protocol by the patients, still achieving positive results in their quality
      of life and physical fitness.

      The elderly will undergo evaluations to characterize the sample through questionnaires, the
      physical fitness assessment will be performed through the Senior Fitness Test (SFT) and
      anthropometric evaluation before (beginning of the research), in the 6th week and after the
      12th week of the research. It will be offered the elderly, instructional material developed
      for this research - printed manual. It will consist of a routine of 12 exercises to be
      performed autonomously for range of motion and muscular fitness, using the environmental
      resources of the home. All control and training guidelines for using the manual will be
      offered through an introductory lecture and subsequent weekly telephone contacts (twice a
      week). Participants should complete their respective program for a total period of 12 weeks
      and mark in the manual how often they performed the exercises. The control group used a
      protocol with 29 home exercises in a longer manual. The results will be obtained from the
      statistical package SPSS 10.0 for Windows and a p <0.05 will be accepted.
    

Detailed description: 
      For the calculation of the sample size, performed in the program Stata 12 version 12, the
      results presented in the dissertation of Souza Filho and collaborators were considered. The
      results of the "Raise" test at the end of the study presented a mean of 14.55 ± 3.12 in the
      intervention group and a mean of 11.16 ± 2.66 in the control group. A 99% power and a type I
      error of 5% would require 27 patients In each group. Predicting eventual losses, this number
      was estimated for 33 patients in each group.

      The elderly will be considered in two groups, one group will participate in a program of 29
      exercises and a second group will participate in a short program with 12 exercises, will be
      developed according to the following parameters:

      Group 1: A manual will be offered, consisting of 29 exercises to be performed at home. The
      guideline is to perform each exercise 6 to 8 times in a gentle manner keeping your attention
      on movement. The first 19 exercises were of range of motion:

        1. Stretching of buttocks in dorsal decubitus position

        2. Trunk side chain elongation in dorsal decubitus

        3. Stretching of hip adductors adopting the "butterfly posture"

        4. Global mobilization of the spine by adopting the posture of cats

        5. Ankle Mobilization

        6. Mobilization of the toes

        7. Circular ankle mobilization

        8. Self-passive ankle mobilization with sitting individual and flexed hip and knee.

        9. Mobilization of the thoracic spine in the sitting posture.

       10. Trunk side chain elongation in sitting posture

       11. Dislocation of scapular girdle

       12. Pelvic girdle dissociation

       13. Cervical lateral inclination

       14. Flexion and cervical extension

       15. Cervical rotational movement (global mobilization)

       16. Abduction and flexion of the shoulder

       17. Internal and external rotation of the shoulder

       18. Arms at the front of the body at the shoulder line, the movement consists of performing
           scapular abduction and lengthening of the flexors at the same time

       19. Mobilization of hand and fingers.

           The 10 subsequent exercises are muscular fitness:

       20. Sit-up to strengthen mainly of the musculature of the quadriceps and glutes

       21. Sits-ups modified

       22. Strengthening of pectoral and biceps

       23. Strengthening of pectoral and modified biceps

       24. Gastrocnemius and soleus strengthening.

       25. Gastrocnemius strengthening and modified soleus

       26. Exercise of balance and coordination

       27. Strengthening of the brachial and iliopsoas triceps

       28. Brachial triceps strengthening

       29. Brachial triceps strengthening This Manual guides its implementation in a progressive
           way and at the end it totals about 30 to 45 min of physical exercises per day. All
           control and training guidelines for use of the manual will be offered through an
           introductory lecture and subsequent weekly telephone contacts (twice a week).
           Participants should complete their respective program for a total period of 12 weeks and
           mark in the manual how often they performed the exercises. Therefore, it guides the
           implementation of daily walks with cumulative effect.

           Intervention Group: the elderly will be offered, instructional material developed for
           this research - printed manual. It will consist of a routine of 12 exercises to be
           performed autonomously for range of motion and muscular fitness, using the environmental
           resources of the home. It will be suggested a daily frequency in the execution of this
           exercise routine. Also, stimuli and guidelines will be given for the practice of active
           movement (walking) so that they accumulate at least 10 to 20 minutes of this activity
           daily. All control and training guidelines for use of the manual will be offered through
           an introductory lecture and subsequent weekly telephone contacts (twice a week).
           Participants should complete their respective program for a total period of 12 weeks and
           mark in the manual how often they performed the exercises.

           • Procedures related to the production of the instructional manual: a literature review
           was carried out in the databases BIREME, PUBMED and in websites of organizations of
           great influence with the theme Physical Activity and Cancer, in specific breast cancer.
           In addition to interviews and theoretical-practical conceptions of professionals with
           significant time in the area in question. This stage lasted three months.

           Within this context, the main exercises of amplitude of movement and muscular aptitude
           were shown in which the realization was easier, reproducible and similar to movements
           performed within the Activities of Daily Life. From there, the photos of the original
           manual were reused for their reduced version and served as illustrations for the
           exercises. This step lasted 15 days.

           During the same period, the researchers conducted the textbook production that provides
           a brief explanation with simplified language about the importance of adopting physical
           exercise in patients with breast cancer under treatment and its impact on the quality of
           life and physical fitness of the patients. Individuals and some guidelines to get into
           the habit of regular walking.

           After the development process, it was diagrammed to proceed with its printing in reduced
           version. This step lasted 30 days.

           The elderly will undergo evaluations for characterization of the sample (questionnaires,
           physical fitness assessment and anthropometric evaluation) before (beginning of the
           research), in the 6th week and after the 12th week of the research. In addition, in the
           6th week, the patient will attend the sector and demonstrate the accomplishment of any
           manual for possible corrections of movement pattern.

           The collection for characterization of the sample, evaluations and tests, will be
           performed at the IMIP on days agreed with the elderly soon after signing the TCLE. It
           will follow the following structuring:

           • Steps: First step: Characterization data of the sample. Anamnesis and questionnaires
           will be carried out.

           Second stage: Anthropometric evaluation. Measurements of weight, height, BMI and body
           composition will be performed.

           Third stage: Screening Pre-evaluation of Signs and Symptoms Acute (Annex 5).
           Measurements of resting blood pressure, resting heart rate, and questioning of possible
           signs of discomfort will be performed before releasing the patient to perform the
           assessments and tests for physical fitness. Patients who present an alteration that
           prevents them from proceeding to the next station will be marked a new date for the same
           to complete the evaluation procedure, in order to enable participation in the research
           and avoid any type of risk.

           Fourth stage: Assessment and tests for physical fitness FTS.

           Used tools

             -  Functional Evaluation For the variables of functional physical fitness, the Senior
                Fitness Test (SFT) will be used, in the test and retest regime (minimum interval of
                3 and maximum of 8 days between the tests) that is constituted by seven Specific
                tests that can measure performance in motor functional abilities on a continuous
                range of wide range, from the condition of greater fragility to the highest degree
                of functional physical fitness. It assesses the ability to perform functional
                movements, such as walking, climbing stairs and getting up, as well as checking the
                muscular fitness, endurance, flexibility and balance of the elderly. It is easy to
                administer by the evaluators, does not require medical authorization and is very
                safe. Each item in the test has follow-up performance standards for men and women
                aged 60-94 years. In addition, the FTS provides reference values in each test item
                that help identify whether the individual is at risk of loss of mobility.

             -  Anthropometric evaluation The following anthropometric data will be collected A)
                Body weight: body mass measurement using TANITA® electronic balance. B) Stature:
                greater distance between the vertex and the soil, the individual being in the
                orthostatic position; C) Perimeter of abdomen: greater abdominal circumference,
                measured with anthropometric tape; D) Percentage of fat: measure of the relative
                amount of fat contained in the body. It will be obtained by perimetry.

           E) Lean body mass index: is the ratio of the lean mass to the square of the height.

           F) Body composition shall be measured using bio-impedance

           • Quality of life assessment Quality of life will be assessed using the questionnaire of
           the European Organization for Research and Treatment of Cancer Quality of Life
           Questionnaire "core" 30 items (EORTC-QLQ-C30) 30, version 3.0. This instrument has 30
           questions, consisting of five functional scales: physical, cognitive, emotional, social
           and role performance; A scale of quality of life and global health; Symptoms of fatigue,
           pain, nausea, vomiting, dyspnea, lack of appetite, insomnia, constipation and diarrhea
           and an item that assesses financial difficulties. The possible responses are: no,
           little, moderately and a lot, scored respectively from 1 to 4. Thus the QLQ-C30
           generates a score of 0 to 100 on the functional and symptom scales according to the
           EORTC score manual. In the functional scale, zero denotes the worst functioning and 100
           the best, while the scale of symptoms is the opposite. Being zero with no symptoms and
           100 is the maximum of symptoms present.

           All data will be collected by the researcher and other properly trained collaborating
           professionals who are part of the IMIP Oncology program and IMIP's Postgraduate Program
           stricto sensu.

           Quality control will be done through a variety of mechanisms: standardized forms and
           questionnaires, detailed instructions for interviewers and / or evaluators, training of
           interviewers and evaluators, review of all forms and questionnaires by fieldwork
           supervisors, repetition of questions Of questions that present inconsistency after
           review and meetings with all interviewers and / or evaluators whenever questions arise.

           The secondary data that will be used have already been collected and are part of the
           research by Souza Filho et al.

           After collecting the data, the collection script will be reviewed and then organized and
           entered into a spreadsheet for statistical analysis. After an exploratory analysis of
           the data in order to identify if they met normality, using the Kolmogorov Smirnoff test,
           the statistical characteristics of the sample and the physical fitness variables will be
           performed. If the comparison is normal distribution, Between the two groups will be
           performed through the student t test, otherwise the Mann-Withey test will be performed.
           To evaluate the pre and post in each group will be performed t Student test paired in
           case of normality or the Wilcoxon test. For the comparison between the different groups,
           in order to identify the homogeneity between the groups, the equivalence test (Levene
           test) will be performed. The results will be obtained from the statistical package SPSS
           10.0 for Windows and a p <0.05 will be accepted.
    

Intervention name(s): Short intervention protocol; Long intervention protocol
Intervention type(s): Other; Other
Intervention description(s): Will be offered an instructional material that will consist of a routine of 12 exercises to be performed autonomously for range of motion and muscular fitness, using the environmental resources of the home. It will be suggested a daily frequency in the execution of this exercise routine. Also, stimuli and guidelines will be given for the practice of active movement (walking) so that they accumulate at least 10 to 20 minutes of this activity daily. All control and training guidelines for using the manual will be offered through an introductory lecture and subsequent weekly telephone contacts (twice a week). Participants should complete their respective program for a total period of 12 weeks and mark in the manual how often they performed the exercises.; This Manual guides its implementation in a progressive way and at the end it totals about 30 to 45 min of physical exercises per day. All control and training guidelines for use of the manual will be offered through an introductory lecture and subsequent weekly telephone contacts (twice a week). Participants should complete their respective program for a total period of 12 weeks and mark in the manual how often they performed the exercises. Therefore, it guides the implementation of daily walks with cumulative effect.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other