Effect of Pilates Method on muscle strength, activities of daily living, amount of fat, and quality of Life in women undergoing treatment for Breast Cancer

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2019
INTERVENTION: Exercise Movement Techniques Meditation Other The experimental group (n = 17) will performed Mat Pilates. The Pilates sessions will have a duration of 180 minutes per week (60 minutes per session, three times a week) for 24 weeks. The classes will be divided into three moments: a) warming up, in which will be included breathing exercises and joint mobility of different body segments; b) main component, in which lower limbs, upper limbs and trunk strength exercises will be performed; c) final component, in which relaxation exercises, lower limbs, upper limbs and trunk stretching will be performed. Mats and accessories (small balls, Swiss balls, sticks, elastics, among others) will be used. Pilates Method principles will be taught the first day of the intervention, as well as the scapular and pelvic girdle neutral posture during sitting, lying and standing position through Pilates specific exercises. The neutral postures and principles will be remembered during the exercises in all classes. As the participants acquire familiarity and ease to perform the exercises, the exercises’ difficulty will be increased, as well as the number of repetitions. The exercises of the main component will be carried out in three sets. The exercises’ number of repetitions will be increased throughout the intervention (six repetitions in the first eight weeks, eight repetitions from the ninth to the sixteenth week and, ten repetitions from the seventeenth to the twenty‐fourth week). Isometric exercises will be also increased the execution time (5, 10 and 15 seconds) every eight weeks. The control group (n = 17) will be asked not to perform the same type of training during the intervention and will participate every 15 weeks at meetings of 60 minutes where breathing, relaxation and meditation exercises will be given. CONDITION: Malignant neoplasm of breast Neoplasms, Malignant Neoplasm of Breast ; Malignant neoplasm of breast PRIMARY OUTCOME: Gait Assessment; ; The gait assessment will be performed using a baropodometer (FootWalk Pro, AM CUBE, France, with a 200 Hz sampling frequency) of 2.0 m in length adapted to a lane, totaling 8.0 m to obtain acceleration and deceleration of the march in the initial and final three meters. The analyzes will be carried out with the Footwork Pro Software (IST Informatique ‐ Intelligence Service et Tecnique, France). Two different tests will be performed. For the first test, the participant will walk in a comfortable and self selected speed in a distance of 8 m, it will be registered only 2 m intermediaries that correspond to the useful area of the equipment. Six cycles will be registered automatically. For the second test, the walk will be performed with a double task, where the participant must respond to a subtraction count, decreasing by three to three 206 ‐ 3, 203 ‐ 3, 226‐3, 223‐3, 306‐3, 303‐3. The evaluator will randomly choose the sequence of the subtraction. ; Data analysis will be initiated through the equipment software. ; The following variables will be analyzed:; a) Pace length will be recorded from the sum of the length of two consecutive steps measured in centimeters; ; b) Cycle pace time will be obtained summing the periods of total stance of the right and left feet, expressed in milliseconds and transformed into seconds; ; c) The walking speed will be calculated by dividing the value referring to the length of the pass by the time of the cycle for each foot separately; ; e) Double stance time will be extracted from the software for each foot, whose values will be summed to get a single value that will be transformed into percentage; the total stance will be considered as 100%. The results of the pace length, cycle time, gait speed and double stance will be obtained separately for each limb, so the average for each value will be calculated.; Hand Grip Strength; ; The hand grip strength (HGS) will be assessed during CVMI with a hand dynamometer (Jamar Sammons Preston) with a scale of 0 to 100 kg. The participants will perform the test in the seated position, with the elbow at a 90‐degree bend following the recommendations of the American Society of Hand Therapists for this dynamometer (ASHT). Three attempts will be performed to both sides (alternately) and the best score will be used for analysis. There will be a 60 s interval between each CVMI.; Hip flexor‐extensor isokinetic and isometric assessments; ; Concentric and eccentric hip flexor‐extensor muscles peak torque, and mechanical work, hip flexor‐extensor muscles isometric peak torque of the prefere lower limb will be measured with an isokinetic dynamometer (BIODEX Medical Systems 4, Shirley, NY, USA). Peak Torque and mechanical work will be normalized by the participant’s body mass (Nm•kg‐1 and J.kg‐1, respectively). Prior to testing, participants will perform a warming up consisting of five minutes cycling at 50 Watts on a cycle ergometer. Thereafter, participants will lay down in a dorsal position on the dynamometer chair. The femur great trochanter will be aligned with lever arm rotation axe with the trunk stabilized with straps over the chest and pelvis. The preferred lower limb tested will be fixed to the dynamometer lever arm at the level of the thigh. The hip and knee of the lower limb not being tested will remain extended and fixed with a strap around the tibia. The lower limb angle of reference will be established at 90° of hip flexion following manufacturer recommendations. The full hip extension will be considered at 0°. Once the participant is positioned, a specific warming up will be carried out with ten repetitions of flexor and extensor muscles concentric contractions at 120º•seg‐1. Afterward, the isometric tests will consist on three maximum isometric voluntary contractions (MIVC) of 5 seconds (s) and a fourth repetition will tested when the coefficient of variation was higher than 5%. The isometric contractions for the flexor muscles will be performed at 15° of hip flexion, while for the extensor muscles will be performed at 100°. After two minutes rest, concentric/eccentric contractions for the flexor muscles at 90° range of motion will be carried out. For the extensor muscles, eccentric/concentric contractions will be performed at 103° range of motion. Two sets of three eccentric/concentric contractions for the flexors and concentric/eccentric contractions for the extensor muscles at 60•seg‐1 respectively, with two minutes of rest between all sets.; Trunk and upper limbs strength assessment; ; Trunk and upper limbs strength will be measured with a portable dynamometer (Cefise N2000 Pro 2.0, Brazil) during isometric maximum voluntary contraction (IMVC). To measure trunk extensor muscles strength will be evaluated, participants will remain standing on a square base of the dynamometer, and the knees slightly flexed at approximately at 160 º, with trunk anterior flexion at approximately 100 º, the elbows will stay extended while the hands hold the dynamometer. At the moment of the contraction, the participant should extend the trunk. The MIVC of the right and left shoulder abductor muscles will also be evaluated at 55º angle in the standing position. A goniometer will be used to obtain the angles used in the test. Participants will perform three CVMIs of 5 seconds, if there is a coefficient of variation of above 5% between contractions; a fourth attempt will be measured. Participants will be encouraged by the evaluators to produce and maintain as much force as possible, and they will have 90 s rest period between the CVMIs.; SECONDARY OUTCOME: Anthropometric and body composition measurements ; ; A mechanical scale with a precision of 0.1 kg, with a capacity of 180 kg (Filizola), will be used to measured participants’ weight. The height will be obtained with a fixed stadiometer with precision of 0.1 cm and maximum extension of two meters (Sanny). The body mass index (BMI) will be calculated using the formula: weight / height2. ; To measure body composition, DEXA ‐ Dual Energy X‐Ray Absorptiometry (Lunar DPX‐NT, General Electric Healthcare, Little Chalfont, Buckinghamshire, UK, 4.7) will be used. Measurements will be obtained in a area at room temperature according to the manufacturer's recommendations. The percentage of body fat (% BF), fat free mass (FFN) in kg, fat mass (FM) in kg and total bone mineral density (TBMD), femur, spine and hip will be measured. ; Cardiorespiratory Capacity ; To evaluate the cardiorespiratory capacity, the six‐minute walk test will be applied, which is performed in a space of 30 meters. The heart rate (HR) will be monitored throughout a heart rate monitor (Polar S810i), blood pressure will be measured using the automatic blood pressure monitor (Omron Healthcare, Inc., Intellisense, model HEM 742 INT, Bannockburn, Illinois, USA). The variables will be obtained at the beginning, immediately after the test and, after five minutes rest of it. Participants will walk as fast as possible (maximum speed) during six minutes. They will be allowed to slow down in case of discomfort and, if necessary, the could stop to rest and then start walking. The evaluators will encourage the participants to maintain a constant speed throughout the test. ; Functional Capacity Assessment ; ; Functional capacity will be assessed through lower limbs agility and lower and upper limbs flexibility with Jones and Rikli (2000) test, described below: ; ; Timed up and Go ; ; Participants will rise from a chair without hands assistance, they will walk three meters in a straight line as fast as possible without running, return straight and sit on the chair. Two attempts will be performed with an interval of one and a half minutes between them. The stopwatch will be triggered at the beginning of the test and the best time in seconds will be used for analysis. ; ; 30‐s chair stand ; ; Participants will start in sitting on a chair of 43 cm height approximately, their feet in contact with the floor and both arms crossed on the chest. They will stand up and down as many times as possible during 30 s. ; ; Back Scratch ; ; To assess shoulder flexibility and mobility, participants will perform the back scratch test. The elbow of the non‐preferred arm will remain flexed behind the back, below the shoulder, with both of the hand palms facing each other; the elbow of the preferred arm flexed over the shoulder with the hand palm facing the back. Participants should try to approximate hands or overlap them and maintain this position for about 2 s. If there is a distance between both middle fingers the value scored would be negative; if the fingers touched each other the value recorded will be considered zero and when fingers or hands were overlapping, the value would be considered positive. Two attempts will be measured and the highest will be considered for analysis. ; ; Chair Sit‐and‐Reach ; Participants will remain seated near the edge of 43 cm high chair (approximately) with the knee of the preferred leg extended, the heel of the assess leg will stay on the floor with the fingertips upwards. The unassessed leg will meet with the knee flexed. The spine will remain aligned, shoulders flexed, elbows extended, one hand on top of the other and the head aligned with the trunk. Participant will perform an anterior trunk flexion. The reference point for the measurement will be the tip of the hallux with the tip of the phalanges of the hands. Negative values will be considered when the phalanges of the greater fingers of the hand do not reach the tip of the hallux, zero will considered if these fingers touch the hallux, and positive values will be scored if the phalanges of the hands go beyond the hallux. The measurements will be obtained with a ruler in centimeters. Two attempts will be performed and the highest value will be used for analysis. ; Nutritional assessment ; A certified nutritionist through a Food Record will carry out the dietary assessment, which will be applied during three days (two weekdays and one weekend day). The food record should contain all food eaten during the day, specifying the quantity of each meal. It will be carried out before, during and at the end of the intervention. ; Pain assessment ; The Brief Pain Inventory (BPI) will be used to assess pain, this is a multidimensional and validated Portuguese instrument that checks pain points and efficacy of therapies. It contains two dimensions: pain intensity and impact of patient life pain, the scores are assessed individually. ; Anxiety and Depression Assessment ; Body Image Assessment ; Fatigue Assessment ; Fatigue will be evaluated by the Fatigue Pictogram, which is validated in Brazil, illustrated and easy to apply. This pictogram measures the intensity and impact of fatigue. ; Physical activity level ; ; Quality of Life ; Quality of Life (QOL) will be assessed through three specific questionnaires for breast cancer patients: ; ; ; Anxiety and depression will be evaluated through the Hospital Anxiety and Depression Scale (HAD), which was previously validated in Brazil. The scale is easy to apply, separates concepts of anxiety and depression. It does not include vegetative symptoms. ; The body image will be evaluated through the Body Image Scale (BIS), which aims to assess breast cancer patients. This scale is validated for Portuguese language. The instrument is composed of 10 questions that assess affectivity, behavior, belief concerning body as a parameter. ; The usual physical activity and sleep level will be evaluated through a triaxial accelerometer motion sensor (Actigraph LLC, model GT3X Pensacola, FL). The devices are lightweight, small in size and designed to be positioned in the assessed to record the movements in the three orthogonal planes: vertical, horizontal anther‐posterior and mid‐lateral. The equipment measures and record acceleration variations with magnitudes of approximately 0.05 and 2.5 G (g = 9.8m / s2) with a frequency of 0.25 to 2.5 Hertz. Each data sample (counts) will be summarized over a specific time interval, called epoch, of 60 seconds. This period of 60 seconds was chosen because it is the one most related to the pattern of low intensity activity and long duration. ; The accelerometers will be positioned laterally at the waist between the navel and the iliac crest. Participants will remain with the accelerometer for seven days. At least four days of a working days and one day during the weekend should be used to have valid data. Participants will be advised to take care of the device, and they should wear it during the whole day during the waking hours, removed it during personal hygiene and / or aquatic activities and before sleeping. Physical activity level data collection will be measured before the beginning of the intervention, after twelfth week of training and at the end of the intervention. ; 1) EORTC ‐ QOL BR23 Questionnaire on quality of life breast cancer module of the European Organization for Research and Treatment of Cancer. The EORTC ‐ QOL BR23 consists of 23 questions, 15 of them related to the side effects of breast cancer treatment, whether surgery, chemotherapy or radiotherapy, 4 questions referring to body image, 3 about sexuality and 1 about future health perspective. Each question has a rating of 1 (no), a little (2), moderately (3), a lot (4). They are classified in different scores, the higher the score, the higher is the symptoms, and the lower the score the lower is the symptoms. ; 3) SF‐36 generic questionnaire for QOL assessment. It has 36 questions, divided into eight dimensions (functional capacity, pain, physical aspects, emotional aspects, social aspects, mental health, vitality and general health status). Each item is coded, 35 grouped and transformed into a scale of 0 indicating poorer health status and 100 better health status. INCLUSION CRITERIA: To be part in this study participants have to be forty years or older, have breast cancer stage one to three certified by the physician and recorded in the medical promptuary; undergoing hormonetherapy, to have an authorization to practice Mat Pilates and the tests; live in the city of Presidente Prudente; not have practiced any type of systematic physical activity six month before the study, and sign the consent form ; 2) EORTC ‐ QOL C30 Questionnaire of QOL from the European Organization for Research and Treatment of Cancer. This questionnaire has 30 global assessments of the health status of the patient. It comprises two questions about health and global QOL, symptom scale (nausea and vomiting, pain, apnea, sleep, disorders, loss of appetite, constipation , diarrhea and fatigue), a functional scale with 15 questions (strenuous activities, self‐care, long or short walk during leisure, depression, worry, tension and irritability). Each question has a classification of 1 (no), a little (2), moderate (3), very (4) . The high score represents a high level of problems and lower scores, a low level of problems, but for general health and functional scales, high scores indicate high quality. The classification and interpretation of the scales for both the EORTC QOL‐C30 and EORTC QOL‐BR23 questionnaires will be converted into numbers from 0 to 100.
Epistemonikos ID: f9f1993ece25e861903f0b2ddffe697ab97086e7
First added on: Aug 24, 2024