CENTRO DE CIÊNCIAS DA SAÚDE
DEPARTAMENTO DE FISIOTERAPIA
EFEITO DO TREINAMENTO DA MUSCULATURA DO ASSOALHO
PÉLVICO ISOLADO E ASSOCIADO A GAMETERAPIA NO
TRATAMENTO DA INCONTINÊNCIA URINÁRIA - UM
PROTOCOLO DE EXERCÍCIOS
Maiara Costa de Oliveira
NATAL – RN
2019
UNIVERSIDADE FEDERAL DO RIO GRANDE DO NORTE
CENTRO DE CIÊNCIAS DA SAÚDE
DEPARTAMENTO DE FISIOTERAPIA
EFEITO DO TREINAMENTO DA MUSCULATURA DO ASSOALHO
PÉLVICO ISOLADO E ASSOCIADO A GAMETERAPIA NO
TRATAMENTO DA INCONTINÊNCIA URINÁRIA - UM
PROTOCOLO DE EXERCÍCIOS
Maiara Costa de Oliveira
Trabalho de Conclusão de Curso
apresentado ao Curso de Fisioterapia
da UFRN, como pré requisito para
obtenção
de
grau
de
FISIOTERAPEUTA.
Orientador: Maria Thereza Albuquerque Barbosa Cabral Micussi
NATAL – RN
2019
AVALIAÇÃO DA BANCA EXAMINADORA
TRABALHO APRESENTADO POR MAIARA COSTA DE OLIVEIRA
EM 20 DE NOVEMBRO DE 2019
1º Examinador(a) ORIENTADOR: Prof.ª Dr.ª Maria Thereza Albuquerque
Barbosa Cabral Micussi
Nota atribuída...
2ºExaminador(a): M.ª Maria Clara Eugênia de Oliveira
Nota atribuída...
3ºExaminador(a): M.ª Lívia Oliveira Bezerra
Nota atribuída...
DEDICATÓRIA
Dedico este trabalho às mulheres, para que todas se empoderem dos seus cuidados em saúde e aos profissionais da assistência à mulher, para que essa seja pautada na boa ciência baseada em evidências, no respeito e na qualidade.
AGRADECIMENTOS
Agradeço a Deus e Nossa Senhora por sonharem meus sonhos antes mesmo de serem meus e escolherem cada caminho que trilhei e cada pessoa que conheci até aqui.
Aos meus pais por me educarem para o bem, me incentivarem a ser o melhor de mim e me oferecerem o necessário para isso.
À minha família e amigos pela presença diária compartilhando cada momento, celebrando cada conquista e sendo fortaleza quando necessário.
À minha orientadora professora Thereza Micussi por não apenas direcionar-me neste trabalho, mas dividir ensinamentos da caminhada da vida.
Às preceptoras da Maternidade Escola Januário Cicco Tatiane Alves e Camila Ribeiro, à preceptora de coração Maria Clara Oliveira e à todos os mestres que me acompanharam até hoje por me formarem e compartilharem seus conhecimentos.
Aos pacientes que tive a oportunidade de conhecer e acompanhar por confiarem e fazerem de mim uma fisioterapeuta e pessoa melhor.
A esta casa que me permitiu aprender, ensinar, pesquisar, tratar, querer saber mais e querer ser mais. Deixo a UFRN com a certeza de que a universidade pública é essencial para o desenvolvimento de uma sociedade.
SUMÁRIO
LISTA DE ABREVIAÇÕES...i
LISTA DE FIGURAS...ii
ABSTRACT...iii
1. INTRODUCTION... 1
2. METHODS...3
2.1. Study Settings ...3
2.2. Eligibility Criteria ...3
2.3. Intervention...4
2.3.1. Warming...4
2.3.2. Pelvic Floor Muscle Training...5
2.3.2.1. Diaphragmatic Exercises...6
2.3.2.2. Bridge Exercises...7
2.3.2.3. Plank Exercises...7
2.3.2.4. Pelvic Mobility Exercises...7
2.3.3. Pelvic Floor Muscle Training Associated to Game Therapy...8
2.3.3.1. Lotus Focus...8
2.3.3.3. Step Basic...9
2.3.3.4. Hula Hoop...9
2.4. Outcomes...10
2.5. Participants Timeline...11
2.6. Sample Size...11
2.7. Recruitment...11
2.8. Allocation...11
2.9. Blinding...12
2.10. Data Collection...12
2.11. Data Management...12
2.12. Statistical Analysis...12
2.13. Data Monitoring...13
2.14. Harm...13
2.15. Ethics and Dissemination...13
3. DISCUSSION...14
ANEXOS...iv
LISTA DE ABREVIAÇÕES
1. PFMT - Pelvic Floor Muscle Training 2. UI - Urinary Incontinence
3. MUI - Mixed Urinary Incontinence 4. PF - Pelvic Floor
5. PFM - Pelvic Floor Muscles
6. SPIRIT - Standard Protocol Items for Clinical Trials 7. HRT - Hormonal Reposition Therapy
8. ICIQ-SF - International Consultation on Incontinence Questionnaire - Short Form 9. PGI-I - Patient Global Intervention
10. PFMTG - Pelvic Floor Muscle Training Group 11. GG - Game Therapy Group
12. PESQCLIN - Laboratório Multiusuário de Pesquisa Clínica e Epidemiológica 13. SPSS - Statistical Package for the Social Science
LISTA DE FIGURAS
Figure 1 - Warming exercises progression
Figure 2 - Pelvic Floor Muscle Training progression Figure 3 - Game Therapy exercises position
ABSTRACT
Aims: to describe a PFMT protocol isolated and associated to the game therapy for Mixed
Urinary Incontinence (MUI) treatment among women facing the climacteric period.
Methods: In order to standardise a Randomized Controlled Clinical Trial intervention
composed by two arms a protocol was created including strength and endurance exercises of Pelvic Floor Muscles (PFM) as well as abdomino-loin-pelvic complex muscles. The study will be composed by 32 volunteers divided into two groups of 16 performing PFMT isolated (PFMTG) and associated to Wii® games (GG) during 8 weeks of 2 appointments each. Results: It is expected an increase on PFM strength and endurance for both groups equally or better vaginal manometry results for GG than PFMTG. It is also expected an increase on PFM improvement of UI symptoms evaluated by ICIQ-SF and 1-hour Pad test for both groups equally or better for GG than PFMTG. It is supposed that GG volunteers present better treatment adherence due to game motivational element. On the other hand it is expected that PFMTG volunteers to show better PFM perception since the exercise focus will be fully on the muscles. Conclusion: It is expected to apply this protocol and to find benefits of this method to climacteric women with urinary incontinence.
1. INTRODUCTION
The supervised Pelvic Floor Muscle Training (PFMT) is shown as the first-line treatment for Urinary Incontinence (UI) especially mixed or stress UI 1,2. The therapeutic exercises performance promote an increase on blood circulation through the Pelvic Floor (PF) area, muscle strength and endurance increase, neural function improvement as well as body awareness and motor coordination improvement during contraction and relaxation of PFM. In addition, the PFMT include proactive exercises 3 which simulate daily life activities whom requires continence preservation.
Previous studies recommend a PFMT frequency between 2 to 3 times in a week 4,5. In relation to the total treatment period, the literature indicates a minimum of 2 months for skeletal muscles since in the first eight weeks of training there are neural effects, such as increased number and frequency of motor unit activation. After this time, occurs muscular hypertrophy due to increased volume and number of myofibrils, essential for morphological or structural adaptations6. Oliveira et al (2017) showed in a systematic review that the training programs of 8 to 12 weeks seem to reduce the amount of urine leakage, and/or to increase PFM strength 7.
The American College of Sports Medicine guideline consider the number of 8 to 12 contractions per series8. Authors suggests that the initial exercise dosis correspond to the maximum number of repetitions or holding time that a patient is capable to perform before the fatigue of PFM 9,10. In order to promote the progression of the exercises, is recommended the creation different levels of difficulty as much as the PFM is trained 11 by increasing the number of repetitions or the difficulty of the exercise.
Another important factor for PFM intervention is the embracement of the different types of muscle fibers. The histological composition of PFM is composed of 70% of type I fibers with the function of maintaining the pelvic organs and 30% of type II fibers that are responsible for urethral closure during activities that trigger intra-abdominal pressure increase. (Bourcier e Bonde, 1991) 12. Furthermore, is important to consider the training of
the abdomino-loin-pelvic complex muscles. Kamel et al. (2012) reported that the abdominal muscles act indirectly in the activation of the PFM, maintaining their coordination, support, endurance and muscular strength. It is also added that the recruitment of the transverse abdominal muscles and internal oblique muscles leads to the activation of the PFM, acting as part of an integrated abdomino-pelvic unit 13-15.
Nowadays, game therapy has been used to assist the rehabilitation of the elderly, children, patients with neurological diseases, pre and postoperative of orthopedic and cardiovascular surgeries. However, there are still few publications about this new modality for UI treatments 16,17 and only one study associates virtual reality with the contraction of PFM simultaneously 16 . It’s important to note that PF dysfunctions, such as UI, are conditions that do not threaten life, but cause significant morbidity. Thus, it’s necessary that new studies evaluate new interventions for UI as well as to approach exercises that involve the abdomino-loin-pelvic cavity associated with direct contraction of the PFM. Thus, this study aims to establish a PFMT protocol to be performed both isolated and associated to game therapy for the recovery from Mixed UI among women during the climacteric period. The hypothesis is that the training associated to game therapy will show better results due to the adherence and motivation promoted by the virtual reality attested by a randomized controlled clinical trial.
2. METHODS
2.1. Study Setting:
This study is a section of a randomized controlled paralleled clinical trial with two arms which aims to evaluate the effect of PFMT performed isolated and associated to the game therapy. The clinical trial will be performed at the outpatient urogynecology clinic of PESQCLIN (Laboratório Multiusuário de Pesquisa Clínica e Epidemiológica) in Natal, RN, Brazil. The exercise protocol included muscle strength and endurance of PFM as well as the abdomino-loin-pelvic complex. Slights adaptations may be carry out according to the voluntaries needs or limitations without prejudice the practice aims. This manuscript will be showed in accordance to the SPIRIT 201318 guideline.
2.2. Eligibility Criteria
Will be included in the search women aged between 45 and 70 years old, who do not
exercise the pelvic floor muscles, do not use Hormone Replacement Therapy (HRT) for at least 3 months and do not have diabetes, neurological diseases or previous epilepsy condition.
Will be excludes those women who presented less than 1g according to the 1 hour Pad-Test and zero according to International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), who have levels III or IV of organs prolapses in accordance to the Halfway Graduation System (Baden-Walker)19, those who are incapable to understand simple verbal orders or do not accept the given orientations. Also who do not achieve the contraction of PFM separately in a visible or palpable way, women with vaginal or urinary infections, intolerable pain reports during the vaginal manometry, more than 20% of absence along the intervention period and those who decided do not continue in the search and/or withdraw their consent.
2.3. Intervention
The intervention will be consisted of the PFMT isolated and associated to the game
therapy using the Wii® games. On both groups the intervention will last 40 minutes and will be divided into warming (5 minutes) and training (30 minutes). The final 5 minutes will be composed by the resting time between the exercises (1 minute each). Each intervention will progress according to the voluntaries performance.
Specific strategies were planned to pursue the voluntaries adherence on the protocol for both groups. For the isolated PFMT group the exercises will progress by changing body position in order to promote the continuation of therapy improvements and avoid monotony. On the other hand, the motivation of the game therapy group on achieve the exercises targets will be the main factor for therapy adherence.
2.3.1. Warming
The first 5 minutes will be composed by exercises which aims to warm the PFM for training (Figure 1) in both groups. In the first 8 appointments, the voluntaries will perform 5 fast contractions followed by 5 slow and sustained for 3 seconds contractions and 3 cough simulations positioned in supine position associated to hips and knees flexion. In addition, 8 plantar flexions were executed in ballet first position - standing with external rotation of hips. For the last 8 sessions, the contractions of PFM will remain the same number while the cough simulations will be increased to 5 and plantar flexions to 12. The voluntaries will rest for 30 seconds between the exercises.
Figure 1 - Warming exercises progression
2.3.2. Pelvic Floor Muscle Training
The isolated PFMT sessions will be composed by four modalities of exercises: diaphragmatic exercises, bridge exercises, abdominal exercises and pelvic mobility exercises. During the weeks of training each modality will have progressions (Figure 2).
Each exercise will be performed in 2 series of 8 repetitions each during the 4 first weeks and 3 series of 8 repetitions each during the last 4 weeks except for the plank exercise.
Figure 2 - Pelvic Floor Muscle Training progression
2.3.2.1. Diaphragmatic Exercises
The voluntaries will lay in dorsal decubitus and perform the diaphragmatic breathing
(abdomen expansion while inhale and return to the initial position while exhale) with one hand positioned on the sternum and the other on the abdomen. This modality will progress by changing the body position from supine to sitting and then standing position. The final progression will be executed in sitting position with a Swiss ball placed on the side of the ribs, the homolateral arm rested on the ball while the contralateral arm will rest on the other lateral of the body. Inhaling will occur normally as the exhaling will be assisted by a
slight pressure from the hand placed on the ribs. The exercises will be progressed every 4 appointments.
2.3.2.2. Bridge Exercises
The bridge exercises will be performed in supine position with both feet on the
stretcher. The volunteers will be instructed to always associate the exercise with breathing by inhale, exhale while raise the hips, perform the PFM contraction and finally inhale again while returning to the initial position. The bridge exercises will also be progressed every 4 appointments to one feet supported on the Swiss ball placed under the calf region and then under the ankle region.
2.3.2.3. Plank Exercises
For the first sessions the contraction of abdomen transversal muscle will be performed in dorsal decubitus under command of “push the navel towards the back” associated to a deep forced exhalation. For the other 12 appointments, the volunteers will execute the ventral plank with support on the elbows and knees sustaining for 5 seconds in the first week. In every session after that the sustentation time will increase 5 seconds, thus the final time will be equal to 60 seconds. It is important to describe that the PFM contraction will be requested every 5 seconds during the exercise in a manner that each volunteer will perform one contraction at the beginning and 12 at the end.
2.3.2.4. Pelvic Mobility Exercises
Initially, during the consciousness period which will last only 4 appointments, the
pelvic mobility will be carry out sitting on the Swiss ball performing pelvic anteversion and retroversion. The progression will be initiated in the third week of training by performing in upright position and after that in hands and knees. The PFM contraction will always be requested during the retroversion.
2.3.3. Pelvic Floor Muscle Training Associated to Game Therapy
The game therapy intervention will utilize the Wii Fit Plus® games from Wii®
equipment. In order to perform the games, this protocol will use the Balance Board® interface between the volunteer and the machine.
In relation to the stability sector of Wii Fit Plus®, the volunteers will play the games Lotus Focus and Penguin Slide positioned sitting on the balance as Step Basic and Hula Hoop standing on the balance from the aerobic sector (Figure 3).
The exercises progression will be carried out by increasing the number of series. During the exercises the television will show signals indicating the Pelvic Floor Muscles contraction.
Figure 3 - Game Therapy exercises position
2.3.3.1. Lotus Focus
The volunteers will play this game sitting on the balance board with no backrest, both
feet on the ground and straight posture. To reach the game’s goal the volunteer has to maintain a virtual candle burning while sounds are performed by the game to distract the players. During the exercise the volunteers will be instructed to contract the PFM and control the trunk stability to keep the candle burning. 2 series of 8 repetitions each will be performed in the first 4 weeks and 3 series of 8 repetitions with 30 resting seconds between each serie in the last 4 weeks of training.
2.3.3.2. Penguin Slide
The volunteers will perform a penguin on a ice block which moves guided by lateral movements placed in the same body position of the previous game. The aim of the game is to collect as much jumping fishes as possible during one minute. The volunteers will perform pelvis side to side movement and the PFM will be activated during the right movements In the first 4 weeks and for both sides from the 5th week totalizing 3 series of 8 repetitions each with 30 resting seconds between them.
2.3.3.3. Step Basic
This game will be executed standing with arms along the body. The volunteers will
step up and down from the balance board following the game command completing a estimated time of 2 minutes and 25 seconds. In the first 4 weeks the volunteers will perform the PFM contraction every 10 seconds totalizing 16 contractions and every 5 seconds totalizing 24 contractions from the 5th week until the end of the training.
2.3.3.4. Hula Hoop
The volunteers will be placed in the same position of the previous game except for resting their arms on the waist. In this game hula hoops are thrown from both sides of the screen while the volunteer tries to capture each of them by maintain the pelvis circle movement. The goal is to capture as many hula hoops as possible. The volunteers will be instructed to perform the movement in a medium to high speed. The PFM contraction will be performed during each hula hoop throwing and the movement will be initiated firstly by the right side and then to the other side totalizing 8 repetitions during 90 seconds for the first 4 weeks. In relation to the 4 last weeks of treatment the volunteers will perform 2 series of 8 repetitions to the right totalizing 180 seconds and after that 8 repetitions to the left during 90 seconds.
2.4. Outcomes
The primary outcome is manometry of PFM. The PeritronTM model 9300AV will be used to evaluate of the pressure exerted by the PFM. Initially the patients will be instructed to empty their bladder adopt the lithotomy position. The pressure generated by the PFM is captured through a conical sensor (probe), introduced into the vaginal canal approximately 9 to 10 centimeters of depth. The value is given in cmH2O. The patient will be instructed to
perform three maximum contractions of the PFM, with a 30-second interval between them
20
, and instructed to not associate the contraction of PFM to the abdominal, hip adductors or gluteal muscles. Will be considered the maximum value of the three trials 21.
The secondary outcomes will be the ICIQ-SF, 1-hour Pad-Test and PGI-I (Patient Global Intervention). The ICIQ-SF is a simple, brief, self-administered questionnaire that classifies urinary loss. It was translated and validated into the Portuguese language by Tamanini et al. (2004)22. It consists of four questions that evaluate the frequency, severity and impact of UI on quality of life, as well as a set of eight self-diagnostic items that allow the evaluation of the causes or situations of UI experienced by patients. Only the first three questions are scored and the total score ranges from zero to twenty-one points. The classification of urinary loss is divided into: no impact (0 point); light impact (1 to 3 points); moderate (4 to 6 points); severe (7 to 9 points) and very severe (10 or more points)23.
The 1-hour Pad Test will be performed to quantify urinary losses. The volunteers will receive a pad (previously weighted) and use it close to the external urethral meatus. The patient will ingest 500 mL of water and rest for 15 minutes. After this time, the volunteers will perform actions which simulates activities of daily living (walk for 30 minutes, go up and down one flight of stairs, sit and get up ten times, cough ten times, pick up objects on the floor five times, run in the same place for one minute and wash the hands in running water for one minute) (Abrams P et al., 1988)24. Finally, the pad will be removed and reweighed on the precision scale. Urinary losses are evaluated and classified: losses lower than 1 g are considered insignificant; between 1.1 and 9.9 g are classified as light losses; between 10 and 49.9 g are moderate losses; and above 50 g severe losses 25.
The PGI-I is a simple, direct and easy to apply global index which aims to evaluate the therapy intervention. This instrument is composed by a single question related to the
current urinary condition compared to the period before the start of treatment. The response ranges from 1 (much better) to 5 (much worse) 26.
2.5. Participants Timeline
For this study, 32 women experiencing the climacteric period and with diagnostic of
mixed UI volunteers will be selected. During the initial evaluation the vaginal manometry, 1-hour Pad Test and ICIQ-SF data will be collected. After that, the interventions will be carried out twice a week for 8 eight weeks totalizing 16 exercises appointments. At the end of protocol will occur a revaluation using the same criteria of the initial evaluation. All the volunteers will be contacted to return one month after the end of the training for a follow-up evaluation.
2.6. Sample size
The sample size will be the result of a probabilistic sampling procedure performed by the Miot formula (2011)27, using the error of 1.96 (5%), error value β of 0.84 (20%) and the minimum difference between the means will be given through a pilot study, through the manometry of thirteen patients with MUI by School Maternity Januário Cicco in Natal-RN. The sample will have 32 participants.
2.7. Recruitment
The volunteers will be recruited from the urogynecology clinic of School Maternity Januário Cicco through writing divulgation and personal contact.
2.8. Allocation
The volunteers will be randomized allocated through the website randomization.com into two groups: PFMTG (pelvic floor muscle training group) composed by 16 volunteers and GG (game therapy group) also composed by 16 volunteers. The sequence will be 1:1.
2.9. Blinding
The researcher A will be the responsible for the randomization and numbering of all the
evaluation sheets which will be delivered to the researcher B who will blindly evaluate the groups. The researcher A will also deliver the sheets to the researcher C who will apply the protocol. In addition the statistic data will be carried out by the researcher D. Evaluators / researchers are physical therapists with expertise in pelvic floor rehabilitation
2.10. Data Collection
The data collection will occur at the Laboratório Multiusuário de Pesquisa Clínica e
Epidemiológica (PESQCLIN) of the University Hospital Onofre Lopes in Natal-RN.
2.11. Data management
The data will be stored and analyzed by a blinded evaluator using the SPSS 20.0
(Statistical Package for the Social Science) software.
2.12. Statistical Analysis:
The data of the sample will be analyzed through the statistical software SPSS 20.0
(Statistical Package for the Social Science). Initially, the Komolgorov-Smirnov test will be
used to test the normality of the data, and Levene, to analyze the homogeneity of the variances.
Descriptive statistics will be used to characterize sociodemographic, clinical, anthropometric, gynecological, obstetric and PGI-I result variables. The independent t test will evaluate the difference statistically between the groups at initial evaluation.
The mixed variance (ANOVA Two-Way) and post-hoc of Tukey analysis will be used to evaluate the time-group interaction and inter and intragroup differences for the variables manometry, pad-test and ICIQ-SF. Sphericity will be tested using the Mauchly test and the Greenhouse-Geisser correction.
A significance level of 5% and 95% confidence intervals will be used for all measurements, as well as effect size (f2of Cohen) and statistical power.
2.13. Data monitoring
This study will not involve participants with severe diseases, communication disabilities
or interventions which can put volunteers lifes in risk. Because of this it is unnecessary the formation of a Data Monitoring Committee (DMC)28.
2.14. Harms
Any adverse event during the research period will be registered and considered for the data analysis as well as the intervention will be interrupted if there is any risk for a participant. However the risks of the study are minimal as musculoskeletal pain resulting from the exercises.
Any withdrawn from the search due to acute musculoskeletal pain or dizziness will be excluded from the protocol and integrated in the statistical analysis as intention to treat.
2.15. Ethics and dissemination
This project was submitted to the Research Ethics Committee of the Federal University
of Rio Grande do Norte and approved under the protocol number 1.438.219. Participants will be informed about the research, receive and sign written informed consent before start the protocol, and the study will be conducted in accordance with the principles of the Declaration of Helsinki. The project was registered in the virtual platform Brazilian Clinical Trials Registry - ReBEC - UTN: U1111-1179-5886
(http://www.ensaiosclinicos.gov.br/).
Any personal information related to the participation in the research will not be shared during or after the study. In addition the final results will be restricted to the researchers.
3. DISCUSSION
Therapies performed through the virtual reality are widely discussed as a method which increases patients adherence among the differents areas of physical therapy. Despite the small number of studies using the game therapy associated to PFMT, it isexpected to find the general benefits of this method as improvement of command comprehension, immersion in the game and interaction with visual, tactile and auditory feedback favouring the physical performance, recovery from symptoms and rehabilitation 29.
As the main purpose of the exercise protocol we expect an increase on pelvic floor muscles strength and endurance for both groups equally or better vaginal manometry results for GG than PFMTG. Due to the PFM rehabilitation, we also expect improvement of UI symptoms evaluated by ICIQ-SF and 1-hour Pad test similarly for the groups or best in virtual reality group. Furthermore, it is expected that GG volunteers present better treatment adherence due to game motivational element.
On the other hand we expect PFMTG volunteers to show better PFM perception since the exercise focus will be fully on the muscles.
ANEXOS
ANEXOS 1
ANEXOS 2
Diretrizes para Submissão de Estudos, Revista Científica Neurology and Urodynamics
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