RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE ANNEXURE - II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION 1 Name of the candidate and address(in MISS. APLONI NEETHA JOSEPH block SAHYADRI COLLEGE OF NURSING letters) ADAYAR, MANGALORE 2 Name of the institution SAHYADRI COLLEGE OF NURSING, SAHYADRI CAMPUS, NH-48, ADYAR, MANGALORE-575007. 3 Course of study and M.Sc. NURSING, subject MEDICAL AND SURGICAL NURSING 4 Date of admission to 04/07/2011 course 5 Title of the topic: EFFECTIVENESS OF INCENTIVE SPIROMETRY V/S BALLOON BLOWING EXERCISE ON SELECTED PULMONARY PARAMETERS OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) IN SELECTED HOSPITALS, MANGALORE. 1 6 BRIEF RESUME OF INTENDED WORK INTRODUCTION “A cure is the end of the medical condition or a treatment that is very likely to end it”. Health is an invaluable part of a human beings life. Without it, people can become uninspired, de-motivated, and unable to thrive for success. Good health favours personal efficiency and contributes to an individual’s lifespan and has much to do with happiness and success. But diseases affect people not only physically, but also emotionally and socially. Diseases can alter one’s perspective of life. It can be acute or chronic.1 A chronic disease is ’’An impairment of bodily structure and function that necessitates a modification of the patient’s normal life and has persisted over an extended period of time”2. Chronic respiratory disease is found to be one of the most distressful conditions, badly affecting human life. Every six seconds people with serious respiratory disease are reminded that their breathing is impaired, and they cannot enjoy life as they used to, as their activities are restricted and that their lives may not be as long .3 One of the most common chronic respiratory diseases prevailing throughout the world is Chronic Obstructive Pulmonary Disease. COPD is a chronic lung disease which refers to several disorders that affect the movement of air in and out of the lung. Although the most important of these are chronic obstructive bronchitis and emphysema. Promotion of exercises is found to be the good conservative management for patients with COPD, because breathing exercises can improve lung functions as well as can strengthen the respiratory muscles, even when the lungs are diseased. The proposed rationale for using incentive spirometry and balloon blowing exercise are to prolong exhalation and thereby improve pulmonary functions. 6.1 NEED FOR THE STUDY: “Exercise is a medicine for creating change in a person’s physical,emotional and mental status” 2 COPD is an umbrella term used to describe lung disease associated with airflow obstruction. Most generally, emphysema and chronic bronchitis either alone or combined fall in to this category. While bronchitis involves inflammation and scarring of the main airways, the bronchial tubes, and emphysema is permanent damage to the walls of the air sacs and loss of lung elasticity, both cause obstruction of the normal air flow. Individuals with COPD exhibit symptoms such as shortness of breath, chronic cough and chronic mucus production. COPD is the leading cause of breathing disability in the world. COPD is caused mainly by smoking, but also by exposure to airborne pollution, to harmful fumes or particles at home or at work, or by inheriting a genetic deficiency.3 Surprisingly little has actually been learned about COPD. Studies are very limited, but things do seem to be improving with some very encouraging studies and clinical trials under way for medications and treatments. There is a very long way to go, however. The good news is that COPD though considered as a chronic debilitating and general fatal disease can be managed, controlled and slowed down. The client can have good and long life with a great deal of quality and joy even after diagnosis with proper treatment, care and exercise.3 COPD is the 5th biggest killer disease worldwide. Every hour COPD is estimated to kill over 250 people worldwide. COPD is the only major cause of death whose incidence is on the increase and is expected to be the third leading cause of death worldwide as well as in India by 2020.The rate of COPD has been increasing nearly three times faster amongst women than men.Women are more susceptible to developing COPD than men, their lung function worsens with less duration of smoking or intensity of smoking than that of men .3 A study was done on global burden of COPD, systematic review and meta analysis was done for population based prevalence of COPD. Of 67 accepted articles, 62 unique entries 101 overall prevalence. The pooled prevalence of COPDwas 7.6% from 37 studies of chronic bronchitis alone (38 studies) was 6.4% and of emphysema was alone 1.8%. The prevalence of physiologically defined COPD in adults aged more than 40years is approximately 9-10%.4 Regular and frequent exercise under supervision can deal with pulmonary function to a larger extent. Incentive spirometry and balloon blowing exercises are 3 proved in decreasing breathlessness in people suffering from chronic lung disease can increase exercise tolerance and it strengthens thoracic muscles. Balloon inflation is proved to be cheap and cost effective method of pulmonary rehabilitation. A study was conducted on exercise training, a therapy for patients with COPD .In this ,11 patients with chronic obstructive pulmonary disease completed an 18week program of exercise training with subjective and objective improvement. Increased activities of daily living were noted by these patients and substantiated by analysis of exercise diaries. The results were resting and exercise heart rate and breathlessness decreased, and maximum tolerated work load increased significantly in all patients. 5 A study was conducted on pulmonary rehabilitation in patients with COPD. In this study 40 patients of stable COPD having severe airflow obstruction was included. Rehabilitation included walking, breathing exercise, controlled coughing and changes in life style activities. Exercise of 30 min duration was performed at home twice daily for 4 weeks supervision. Six-minute walking distance, FEV1 [forced expiratory volume in first sec of expiration] and various indices of chronic respiratory disease questionnaire were measured in samples before and after intervention. The study concluded that domiciliary pulmonary rehabilitation for 4 weeks resulted in significant improvement in the quality of life and exercise tolerance with an improvement in FEV1.6 Many studies proved that incentive spirometry increases inspiratory volume, maintain alveolar ventilation, increases vital capacity and inspiratory reserve volume and even prevent atelectasis. Many articles say that balloon inflating exercise can increase pulmonary parameters.Hence, the investigator felt that there is a need to conduct a study on effectiveness of incentive spirometry and balloon blowing exercise on patients with COPD . 6.2 REVIEW OF LITERATURE The study was conducted to evaluate the effects of incentive spirometer[IS] on pulmonary function tests, arterial blood gases [ABG], dyspnoea and healthrelated quality of life in patients hospitalized for COPD . A total of 27 consecutive patients (mean age, 68.4 +/- 7.9 years; 26 males) admitted for COPD exacerbations were recruited for the study. In total, 15 (IS treatment group) used IS for 2 months, together with medical treatment. The remaining 12 (medical treatment group) were given only medical treatment. Pulmonary function and blood gases were measured. Assessment of dyspnoea by visual 4 analogue scale (VAS) and quality of life using the St. George's Respiratory Questionnaire (SGRQ) were performed at admission and after 2 months of treatment. The activity, impact and total scores for the SGRQ improved (all P < or = 0.0001), PaCO2 values decreased (P = 0.02), PaO2 and PAO2 values increased (P = 0.02 and P = 0.01, respectively) in the IS treatment group.. The study concluded that IS improved ABG ,pulmonary functions and health-related quality of life in patients with COPD exacerbations. 7 A study on regular balloon inflation for patients with chronic bronchitis was conducted to check the effect of regular lung exercise on severity of symptoms particularly breathlessness. 28 patients were randomly recruited with spirometrically proved airway obstruction. The 13 patients randomised to the study group had a mean age of 65 years and a mean FEV1: FVC ratio [forced expiratory volume in first sec of expiration /forced vital capacity] of 0:43. The 15 controls had a mean age of 69 years and an FEV1: FVC ratio of 0:46. The results proved a significant reduction in the breathlessness score after regular balloon inflation, together with slight, improvements in wellbeing and 6minute walking distance in the balloon group. 8 A study was conducted on significance of regularly blowing up ordinary rubber balloons in people suffering from chronic lung disease. Randomly 22 participants with chronic bronchitis and emphysema were selected. In that 11 women 9 men with average age 65, were randomly assigned to the balloon blowing group and asked to inflate one new ordinary balloon to a diameter of 7 inches, 40 times a day for 8 weeks. The rest, 11 men whose mean age was 69 years was taken as control group, without treatment. Before and after the study, pulmonary technicians assessed the pulmonary abilities of all participants. And the study reported a significant reduction in breathlessness after regular balloon inflation.9 A study was conducted on incentive spirometry [IS] performance as a reliable indicator of pulmonary function in the early post-operative period after lobectomy. Nineteen patients [16 men, 3 women]of 60 years of age undergone lobectomy for lung cancer was selected .All had obstructive pattern with FEV1/FVC below75%. Lung volumes, including functional residual capacity [FRC] and residual volume [RV] measured using spirometry and the helium dilution technique and ARE measured pre-operatively and post-operatively at 1, 2, 3 and 8 and at 2 months. IS performance was well correlated (R) during the first 8 postoperative days with vital capacity (VC) (R between 0.667 and 0.870) mainly due to the excellent correlation with the inspiratory reserve volume (IRV, R between 0.680 and 0.895) but was 5 poorly correlated with expiratory reserve volume (R below 0.340), RV (R below 0.180), and FRC (R below 0.470). The study concluded that, IS can be used as a simple mean to follow lung function, especially VC and IRV, in the postoperative period in spontaneously breathing patients. IS is non-invasive and can be performed repeatedly at the bedside in the intensive care setting. 10 A study was carried out on respiratory rehabilitation in patients with COPD that assessed functional or maximal exercise capacity, HRQL [health related quality of life], or both. Respiratory rehabilitation was defined as exercise training (for at least 4 weeks) with or without education, psychological support, or both. The most commonly used measure for HRQL was the chronic respiratory questionnaire, in which responses were presented on a 7point scale. The control groups received no rehabilitation. Within each trial and for each outcome an effect size was calculated. The overall effect of treatment was compared with its Minimum Clinically Important Difference (MCID). Out of 14 trials done significant improvements were found for all the outcomes. For two important features of HRQL, dyspnoea and mastery, the overall treatment effect was larger than the MCID: 1·0 (95% CI 0·6–1·5) and 0·8 (0·5–1·2), respectively, compared with an MCID of 0·5. For functional exercise capacity (6min walk test), the overall effect was 55·7 m (27·8–92·8), and for maximum exercise capacity (incremental cycle ergometer test), 8·3 W (2·8–16·5).The study concluded that respiratory rehabilitation relieves dyspnoea and improves control over COPD. 11 A study was conducted on respiratory muscle training with incentive spirometry resistive breathing device [ISRBD]. This study focused on the effect of inspiratory muscle training on the strength of the respiratory muscles, exercise performance, clinical manifestations, and activities of daily living. Inspiratory muscle training was performed by the use of an ISRBD that gave a linear inspiratory resistance of 50 cm H2O/L/sec at 1 L/sec flow. Subjects used an ISRBD twice a day for 15 minutes each day for 4 weeks. Strength of respiratory muscles as measured by PI max and sputum expectoration improved significantly (P < 0.05) but there was no significant change in exercise performance (12-minute walk distance), other clinical signs and symptoms, or activities of daily living. Visual feedback given by the bellows of the ISRBD that inflated and deflated with inspiration and expiration apparently served as a positive reinforcer and motivator for most subjects. The study concluded with a high compliance rate (98%) of the participants.12 A study was conducted in Mangalore on effectiveness of deep 6 breathing exercise on pulmonary function among patients with chronic airflow limitation. Out of 40 patients randomly selected, 20 were assigned to experimental group and next 20 to control group.The PFT parameters (FEV1&FVC) were assessed in both group before intervention. Deep breathing exercise was provided for the experimental group for twice daily for 7 days.On the 7th day PFT parameters of both groups were assessed.The result showed the mean score of FVC and FEV1 is 23.80 and 26.80 respectively for experimental group ,where as 7.70 and 6.90(p<0.05) for the control group. The study concluded that deep breathing exercise is effective in improving pulmonary parameters.13 6.3 PROBLEM STATEMENT: Effectiveness of incentive spirometry v/s balloon blowing exercises on selected pulmonary parameters of patients with chronic obstructive pulmonary disease (COPD) in selected hospitals, Mangalore. 6.4 OBJECTIVES OF THE STUDY: The objectives of the study are: To assess selected pulmonary parameters before and after interventions among patients with COPD in both groups. To find the effectiveness of incentive spirometry exercise on selected pulmonary parameters of patients with COPD. To find the effectiveness of balloon blowing exercise on selected pulmonary parameters of patients with COPD. To compare the effectiveness of incentive spirometry and balloon blowing exercise on selected pulmonary parameters of patients with COPD. To find an association between pre-test level of pulmonary parameters and the selected demographic variables of patients with COPD 6.5 OPERATIONAL DEFINITIONS: 7 EFFECTIVENESS: In this study it refers to the extent to which incentive spirometry and balloon blowing exercise enhance the pulmonary parameters such as peak expiratory flow rate, chest expansion, breath holding time and inspiratory capacity of patients with COPD as measured by peak flow meter ,inch tape ,stop clock and incentive spirometer INCENTIVE SPIROMETRY EXERCISE: In this study, it refers to expiratory breathing exercise aided by incentive spirometer, administered 2 cycles per day, eachcycle with 10 expiratory efforts,given once in morning and once in evening. BALLOON BLOWING EXERCISE: In this study, it refers to instructing the patients to blow the balloon to its maximum limit 10 times per cycle, given once in morning and once in evening. SELECTED PULMONARY PARAMETERS: In this study, it refers to variables reflecting the status of pulmonary function which includes peak expiratory flow rate, chest expansion, breath holding time and inspiratory capacity as measured by peak flow meter ,inch tape, stop clock and incentive spirometer respectively. PATIENTS: In this study, it refers to male and female adults between 40 to 60 years of age who have got admitted in the selected hospital with diagnosis of COPD. 6.6 ASSUMPTIONS: The study assumes that: COPD affects pulmonary parameters Active breathing influences pulmonary function 8 6.7 DELIMITATIONS: Study is confined to selected health care settings of Mangalore. Study is assessing only a few pulmonary parameters like peak expiratory flow rate, chest expansion, breath holding time and inspiratory capacity. 6.8 HYPOTHESIS: Hypothesis will be tested at 0.05 level of significance H1: The mean post test pulmonary parameters will be significantly higher than mean pre-test pulmonary parameters after receiving incentive spirometry exercise among patients with COPD H2: The mean post test pulmonary parameters will be significantly higher than mean pre-test pulmonary parameters after receiving balloon blowing exercise among patients with COPD H3: There will be significant difference in pulmonary parameters between patients who receive incentive spirometry and balloon blowing exercises among patients with COPD H4: There will be significant association between pre-test level of pulmonary parameters and selected demographic variables among patients with COPD. MATERIALS AND METHODS: 7.1 SOURCE OF DATA: Data will be collected from patients with COPD in a selected hospital, Mangalore. 7.1.1 RESEARCH APPROACH AND RESEARCHDESIGN: Quantitative research approach will be used for this study Quasi experimental research design,in which two group pre-test, post test design will be used for this study PRE-TEST TREATMENT 9 POST-TEST O1 X1 O2 O1 X2 O2 O1- Pre-test assessment of selected pulmonary parameters of patient with COPD X1- Administration of incentive spirometry exercise X2-Administration of balloon blowing exercise. O2- Post-test assessment of selected pulmonary parameters of patient with COPD 7.1.2 SETTING: Study will be conducted in medical wards of selected hospitals, Mangalore. 7.1.3 POPULATION: 7. Population of the study consists of adult patients with COPD admitted at selected hospitals, Mangalore. 7.2 METHOD OF DATA COLLECTION: 7.2.1 SAMPLING PROCEDURE: Non-probability Purposive sampling will be used to select samples. 7.2.2 SAMPLE SIZE: Sample consists of 40 patients with COPD, in which 20 patients in incentive spirometry group and 20 in balloon blowing exercise group. 7.2.3 INCLUSION CRITERIA: Both male and female inpatients with COPD. Patients with COPD who are in the age group of 40 to 60 years. 7.2.4 EXCLUSION CRITERIA: 10 Patients with COPD who are critically ill. Patients with COPD who practice any other breathing exercises 7.2.5 INSTRUMENTS USED: Demographic proforma includes age ,gender, education, occupation, habit of smoking, duration of smoking ,number of beedis or cigarettes used per day Clinical proforma includes inspiratory capacity(ml), peak expiratory flow rate(l/min), chest expansion(cm) and breath holding time (sec) 7.2.6 DATA COLLECTION METHOD: Formal administrative permissions will be obtained from concerned health care setting authorities. The nature and purpose of the study will be explained. Informed consent will be obtained from the participants. Demographic data and pulmonary parameters will be collected from the samples by administering tools on pre-test. Administer incentive spirometry and balloon blowing exercises to respective groups for 5 days. The post-test data will be collected from the samples after administering interventions. 7.2.7 DATA ANALYSIS PLAN: Demographic data will be analyzed using descriptive statistics: , frequency , percentage ,mean ,median, and standard deviation. Effect of incentive spirometry and balloon blowing will be analyzed using inferential statistics Paired‘t’ test will be used for the significance of difference between pre-test and post-test score of each intervention. Independent‘t’ test will be used to compare the post-test scores of both groups 11 Chi-square test will be used to find an association between pre-test level of pulmonary parameters and selected demographic variables. 7.3 Does the study require any investigations or interventions to be conducted on patient or other human or animals? Yes,asapart of study incentive spirometry and balloon blowing exercise will be administered on patients with COPD,which is of non-invasive type 7.4 Has ethical clearance been obtained from your institution? Ethical clearance will be obtained from concerned authorities Formal administrative permission is obtained from concerned authorities Informed written consent is obtained from participants 12 8. LIST OF REFERENCE 1) Sighting the importance of health to human being[internet] 2009. Available from: www.chalkmedia.co.uk.org 2) Park k. Textbook of preventive and social medicine. 17thed. Jabalpur: Banarsidasbhanot publishers;273-94 3) WHO .Chronic obstructive pulmonary disease: Chronic respiratory diseases. Geneva; 2008. Available from: URL:http//www.who.co.in. 4) Halbert RJ, Natoli LJ, GanoA ,Buist AS. Global burden of COPD:systemic review and meta analysis.ERS Jornal.2006 ;28(3):523-32. 5) Harry B, John F, Robert F. Exercise therapy for patients with COPD. Chest .2011 ;57(2):116-121. 6) Rosa G, Casan P, Belde J. Pulmonary rehabilitation in patients with COPD-a randomized trial. Chest.2000 ;117(4):976-983. 7) BasogluOK ,AtaserverA,Bacakagiy F. The efficacy of incentive spirometry in patients with COPD. Respirology.2005 ;10(3):349-53. 8) Chuahan AJ , John PM ,Linda G ,Patrick D. Regular balloon blowing for chronic bronchitis.BMJ.1992 ;304:1668-9. 9) Edward J, Kifer H. Simple exercise for breathlessness. BMJ.2004;24:567-9 10) Baslin R, Morance JJ ,Kahn GJ, Melot C .Incentive spirometry a reliable indicator of pulmonary function. American college of chest physician .2007 ;3. 11) Wong Y,GuyattGH,King D, Cook DJ, Goldstein RS. Meta analysis respiratory rehabilitation of chronic obstructive pulmonary disease. Mc master university. ACP J Club. 1997;126(2):38. 12) Larson M, Kur MJ. Respiratory muscle training with incentive spirometry resistive breathing device. Journal of heart and lung.1984 ;13(4):341-5 13) Mathew J, D’silva F .A study on effectiveness of deep breathing exercise on pulmonary function among patients with chronic air flow limitation. International journal of nursing education. 2011;3:34-7 13 14
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