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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE 1 PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERRTATION NAME OF THE MANJUNATHAN.C, IST YR M.SC CANDIDATE & NURSING, ADDRESS SUSRUTHA COLLEGE OF NURSING,#23 PAPAIAH GARDEN,DIAGNOAL ROAD,BSK III STAGE,CHANAMMANKERA ACHUKATTU, BANGALORE-560 085. 2 NAME OF THE INSTITUTION SUSRUTHA COLLEGE OF NURSING. 3 COURSE OF STUDY AND SUBJECT DEGREE OF MASTER OF SCIENCES OF NURSING. MEDICAL AND SURGICAL NURSING. 4 DATE OF ADMISSION TO COURSE 30/6/2008 5 TITLE OF THE TOPIC A STUDY TO ASSESS THE EFFECT OF INTRADIALYTIC STRETCHING EXERCISE ON MUSCLE CRAMPS PATIENTS UNDERGOING HEMODIALYSIS IN SELECTED HOSPITALS AT BANGALORE. 6. BRIEF RESUME OF THE INTENDED WORK: 6.1 INTRODUCTION “The financial basis of quality of life involves continuous functioning reciprocal interaction, between persons and their environment”. Alexander & Williams (1981) The crucial areas of human life are physical well being social activities, personal development, recreation & economic circumstances and these factors largely influence the persons relationship with environment. 6 To a greater extent, the quality led by a human being is influenced by his physical well being. Physical well being depends upon the accurate balance of components like fluids, solutes and even some waste materials. Thus maintenance of volume of the various body fluids is essential to man’s survival. Given unrelenting daily acquisition of food and fluids, preservation of the internal environment requires the continuous excretion of these dietary substances in amounts that balance precisely the quantities acquired by ingestion or metabolic transformation. Although losses from skins, lungs and intestine normally contribute to this excretory capability, kidneys are bearing the greatest responsibility for solute and water 4 removal. Different kidney pathologies challenge these functions and puts human life in danger. Two such important pathologies are acute and chronic renal failures. But in early years itself, some had the vision and courage to risk everything in search of the answer for treating renal failure and the first clinical dialysis on a uremic man was performed in mid October 1924 by George Hass in Germany. 5 Hemodialysis is by far the most common method of treatment employed for renal failure. It offers a more rapid change in plasma solute composition within a four hours. 4 Chronic Hemodialysis was first introduced in 1960s to extend the lives of patient with end stage renal disease and by 1982, almost 1,00,000 patents throughout the world were being alive by some from of dialysis therapy. Dialysis 13 removes many of the toxins responsible for the uremic syndrome and prolongs survival. However the dialysis treatment thus not fully correct the uremia and may be associated with treatment related complications. These complications prevent patients from attaining a state of full health and interfere with many aspects of life. The degree to which an individual patient can adopt to their medical and psychological stresses is reflected in the quality of life of that individual. 4 Non specific physical symptoms are common in dialysis patients but a few methods are available to measure their severity. The six most important symptoms of Hemodialysis patients are tiredness, muscle cramps, (Parfery, et al., 1988) Pruritus, dysphnoea, headaches and joint paints 6 Nurses, Patients family and other health care providers share the interest in maximizing positive outcome of thus can be achieved by intervening the patients problems during the procedure. 6 In this study, the investigator is interested to elicit the effect of intradialytic stretching exercise on muscle cramps experienced by the patients during Hemodialysis. 9 6.2 NEED FOR STUDY Chronic kidney disease (CKD)in an important non communicable disease epidemic that effects the world population including India. The prevalence of end stage renal (ESRD) is rising through out the developed and developing countries mainly due to diabetes mellitus and hypertension. 6 There are currently 10,65,000 people on Hemodialysis worldwide (European dialysis and transplant nurses association \European Renal Care Association Journal,2005).CKD will kill 36 million people by the year 2015. In India 10 lakh people suffer from kidney failure and more than 4 crores are at risk (Karnataka Kidney research foundation, 2006) 18 In south India, an average of 500 patients register for Hemodialysis each year (Health management centre, 2005) 18 Dialysis saves lives. However alone cannot make those lives active and meaningful measures should be employed to improve physical well being of the patients. Exercise of crucial in the rehabilitation of many individual with chronic renal deficiency. 6 Almost of patients complain if muscle cramps at one or other time during dialysis usually of lower extremities that too of calf muscles. They are managed with normal saline infusion. Simple calf massages and even by temporarily stopping the ultra filtration till cramps go off. Some of them are prescribed carnitine preparations regularly for preventing muscles cramps. Non pharmacologic prophylactic measures are not employed. 1 In early stages of physicians were the one’s who prepared the equipment for Hemodialysis monitored the patient and terminated the treatment. It was not long before physician began to rely on nurses to perform most of the patients care decisions during entire Hemodialysis. Currently nurses carryout 20-100% of the technical functions. This reveals the high responsibility and multiple roles (career, advocate, technical supervisor etc) Hemodialysis. Patients. Nurse 5 Patient on chronic maintenance Hemodialysis are confronted with several complications related to the treatment muscle cramps being among the most commoncomplaints is estimated to occur in up to 20% of Hemodialysis sessions. Lee (1999) quoted in Dialysis and Transplantation journal that in a specific study involving 14000 Hemodialysis treatment on 103 patients the cumulative incidence of cramps was estimated to be 86% 16 Since cramps are a common intradialytic event, the discomfort leads to premature termination of the treatment, non compliance with the prescription and therefore under dialysis. This interfering with the muscle cramps and even preventing the occurrence become a major responsibility of the personal incharge of the patients. Since nurses are taking care of Hemodialysis patients almost every where it becomes predominantly the nurse’s role. 12 Muscle cramps are prolonged involuntary muscle contraction. To relieve an established cramps on must passively stretch the contracting muscle. particular muscle can also prevent attacks (Hansen, 2005) Prophylactic stretching of the 6 However, only a few patients are able or willing to participate in exercise training and stretching which is organized on an outpatient basis. As a consequence, exercise programs are through to be better incorporated into the dialysis sessions. But incase of stretching exercise, the patients positions in be during dialysis prevent self stretching. Thus the investigator has opted to provide passive calf stretching exercise prophylactically during Hemodialysis to relieve or prevent muscle cramps. 6.3 REVIEW OF LITREATURE The task of reviewing research literature involves the identification selection, critical analysis and written description of existing information in the topic of interest. In this chapter, an attempt has been made to bring out the available literature which helped in projecting the widened perspective of the study. This chapter also involves the concept ional frame work. 1. Literature related to the effectiveness of physical exercised and outside Hemodialysis sessions. 2. Literature related to muscle cramps. 3. Literature related to stretching exercise. 1.Literature related to the effectiveness of physical exercised and outside Hemodialysis sessions. Storer, Casaburi, Sawelson, et, al., (2005) studied 12 maintenance Hemodialysis patients by providing them incremental and constant work rate cycle exercise for 6-8 weeks and found out that eight weeks of leg cycling during Hemodialysis in maintenance patients improves not only cardio pulmonary fitness and endurance but also muscles strength, muscle power, fatigability and physical functions. 17 Banerjee, Knog and Farrington (2004) studied two groups of 10 patients in each by exercise them sub maximally using a stationary cycle during isovolemic dialysis for 10 minutes followed by 10 minutes rest and again 10 minutes of exercise. Cardiac output, peripheral resistance, blood volume and stroke volume were measured using ultra sound dilution and concluded that the hemodynamic response to exercise during hemodialysis is comparable with that in normal individuals. 3 Rrzzeoli, Cerretano, Normanno, et,al.,(2004) did a study in eight patients who participated in physical training with motorized cycle during dialysis treatment. The study suggested that exercise during the dialysis treatment was safe and consented either better psychosocial performance or better dialytic efficiency. 4 Depaul, Moreland, Eage, et, al., (2002) conducted a study on the background that individuals with end stage renal disease on hemodialysis therapy and reduced aerobic exercise capacity and muscle strength. They had done a single blind randomized placebo controlled trail of an exercise intervention in hemodialysis patients. It consisted of progressive resisted isotonic quadriceps and hamstring exercise and training on a cycle, ergometer weekly thrice for 12 weeks. They inferred that the exercise program improved physical impairment measures. (11) Cappy, Jablonka and Schrorder (1999) studied 32 hemodialysis patients who participated in a progressive self paced exercise programme including cycling before or during hemodialysis. On waling or treadmill before hemodialysis patients also had the option of doing stretching and light weight exercise during hemodialysis. They were assessed after a duration 3,6 and 12 months of participation for physical strength, weight, Blood Pressure, electrolytes, hematocrite, glucose and intradialytic cramping. 9 Result showed that all patients had improvement in measures of physical performance. Ridley, Hoey and Ballagh-Hoves (1999) conducted a Quasi experimental one group pre and post test design study. Eight subjects completed a 12 week exercise programme involving warm-up, stretching, strengthening and cardio vascular training. The result demonstrated improvement in participants, physical capacity, quality of life and ability to perform activities of daily living. They concluded that an exercise during dialysis programme was safe and had the potential to result in positive patients outcomes. 1 2. Literature related to muscle cramps: Brass, Adler, Siestema, et,al(2002) has studied 122 patients on maintenance hemodialysis peripheral arterial disease was determined by measurement of ankle brachial index pre and post dialysis in lower extremities. Intradialytic cramps experience was assessed from history, 52.1% patients reported intradialytic cramps. Old age people were only 37.5% and it was inferred that there was no relationship between cramps during dialysis and peripheral arterial disease. 8 Pratee Pavanich (1999) studied 24 patients with nocturnal calf cramps. They are divided into two groups to quantitatively compare the effect of trigger point injection and oral quinine. The study was conducted for four weeks of the study parameters were cramp frequency, duration, pain intensity and cramp index. The outcome of all measures were found to be significantly better in group treated with trigger point injection. Results supported that gastrocnemius trigger point was one cause of nocturnal calf cramps. 24 Tonge (1998) studied an alcoholic poly neuropathy man’s sequential spreading of cramps from unilateral to contra lateral leg muscles and phasic discharges observed by needle electromyography. He inferred that sensory inputs from peripheral nerves played a critical role in the generation of cramps. 14 Mandal (1995) projected that quinine appeared to decline the excitability of motor end plate, thus reducing muscle contractibility. 23 Naylor and Young (1994) surveyed a population of 218 patients and found out that the overall prevalence of muscle cramps was 37% and most commonly experienced in muscles of the leg in 83% cramps suffers. 2 Dial (1978) studied 46 complete dialysis treatment sessions. Electromyographic (EMG) activity was recorded from a leg muscle in patients who had cramps. Results indicated that the mean muscle cramp latenly from start of dialysis was 248 minutes and average cramp was 10 minutes in duration. Also tonic electromyographic activity in patients with muscle cramps showed a continued increased throughout the latter part of dialysis. This suggested that increase in electromyographic activity might be casually related to muscle cramps. 11 3. Literature related to stretching exercise: Turney (2006) published that the severe muscle cramps are experienced nearend of the dialysis treatment. He suggested to try a program of gentle stretching and toning exercises targeted at the muscles which tend to cramp during dialysis. 25 Coppin (2005) quoted an uncontrolled study with suggested that calf stretching exercises 9 could prevent nocturnal leg cramps. Kannan (2005) recommended a non pharmacologic approach of stretching and massaging as the first line treatment for idiopathic nocturnal leg cramps. 19 Hansen (2005) published a treatment protocol for cramps in end stage renal disease which concluded that to relieve an established cramp, one must passively stretch the contracting muscle. In some cases, this could be accomplished by simple walking around which produced a relative dorsiflexion of foot. Prophylactic stretching can also prevent attacks, as positions in bed might prevent foot dorsiflexion. 16 Lee (1999) started that massage and vigorous stretching of the cramped muscle would causes the spasm to yield in hemodialysis patients. 22 Sontag (1998) hypothesized that cramps are caused by muscle and tendon shortening. He had discussed several simple stretching exercise which mimic the effect of squatting that frequently resulted in immediate and dramatic relief of cramps. 1 Schwellnus (1997) described that during muscles cramps, electromyographic activity was high and passive stretching was effective in reducing this stretching relieved cramp by probably invoking the inverse stretch reflex. Stretching also invoked afferent activity from golgi-tendon organ to relieve cramps. 2 Leclerc (1996) emphasized that mechanic treatment of an acute muscle cramps involved stretching the affected muscle and this could be done prophylactically also. 20 Riley (1995) reviewed that treatment for leg cramps included stretching exercise, quinine and vitamin E. 9 MC Gee (1990) proposed that the best evidence supported stretching exercise for ordinary muscle cramps. He also proposed for future study areas of this common symptoms. 2 6.4 STATEMENT OF PROBLEM: A STUDY TO ASSESS THE EFFECT OF INTRADIALYTIC STRETCHING EXERCISE ON MUSCLE CRAMPS PATIENTS UNDERGOING HEMODIALYSIS IN SELECTED HOSPITALS AT BANGALORE. 6.4.1 OBJECTIVES OF THE STUDY: 1. To assess the effect of intradialytic stretching exercise on muscle cramps among patients undergoing hemodialysis. 2. To associate the effect of intradialytic stretching exercise with demographic variables. 6.4.2HYPOTHESIS: Patients receiving intradialytic stretching exercise’s will experience less muscle cramps during dialysis than those who are not. 6.4.3 OPERATIONAL DEFINITIONS: ASSESS: It refers to evaluation or judgment of client’s in the hemodialysis units. EFFECT: The result of intradialytic stretching exercise after admitting to patients during hemodialysis. INTRADIALYTIC: Pertaining to the end of second hour of a four hours hemodialysis sessions. STRETCHING EXERCISE: Exercise performed by the investigator for the gastrocnemius and solius (calf) muscles of the patient during hemodialysis. MUSCLE CRAMPS: Painful involuntary spasms of the calf muscles of patients during hemodialysis. 6.4.4 RESEARCH VARIABLE: INDEPENDENT VARIABLE: The independent variables are name, age, sex,education ,occupation, life style, income . and practice of physical exercise DEPENDENT VARIABLE: It is effectiveness of intradialytic stretching exercise 6.4.5ASSUMPTION: a. Hemodialysis results in sodium depletion in muscles. b. Exercise improves perfusion. c. Exercise improves stimulation of muscles, bones and nerves. 6.4.6 LIMITATION: The stretching exercises were limited to calf muscles only. 7. MATERIAL AND METHODS: Methodology refers to the means of gathering data that are common to all sciences including nursing. It is different from the word technique which refers to specific tools that are used in a given method. We may classify all method of data collection method as follows. 7.1 SOURCE OF DATA: The investigator colleting the data from hemodialysis patients in nephrology department. 7.2 MOTHOD OF COLLECTION OF DATA: 7.2.1 RESEARCH DESIGN: A Post test only experimental design was used for this study. It could be represented as E X O1 O2 C O1 E- Experimental group C- Control group X- Intervention O2 7.2.2 SETTING: The study was conducted in hemodialysis unit in selected hospitals, at Bangalore. 7.2.3 POPULATION The target population of the study was the patients undergoing hemodialysis in the hemodialysis units. 7.2.4 SAMPLE SIZE: The sample size consisted of 60 patients who satisfied the sample section criteria with 30 patients each in the experimental and control group. 7.2.5 SAMPLE TECHNIQUE: The technique adopted for this study was random sampling patient were selected randomly by lottery method. 7.2.6 SAMPLING CRITERIA: 1. INCLUSION CRITERIA: a. Patients of age group 20-60 years b. Patients who could understand either English or Kannada. c. Patients who were willing to participate d. Patients who under went hemodialysis for duration of four hours. 2. EXCLUSION CRETERIA: a. Emergency hemodialysis patients b. Patients with femoral catheters c. Patient with any lower limp pathology. 7.2.7 COLLECTION OF DATA The investigator will collect the date from the patient in nephrology department. The data’s are depends up on the Part – I Demographic variables are age in years, sex, education status, lifestyle, occupation income and practice of physical exercise etc,. Part – II Clinical variables are previous experience of muscle cramps, coping strategies adopted, weight of fluid removed during dialysis, repeated use of dialyser, frequency of dialysis and systemic illness etc. 7.2.8 DATA ANALYSIS METHOD The investigator will use descriptive statistical technique such as mean, median, mode, standard deviation, inferential statistics like chi square test and related statistical analysis. 7.2.7 TOOL OF RESEARCH Investigator will develop a questionnaire for the study. 7.2.9 METHOD OF DATA ANALYSIS AND PRESENTATION The investigator will use descriptive statistical technique such as mean, median, mode, standard deviation, inferential statistics like chi square test and relevant statistical analysis. 7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTION TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS? IF SO, PLEASE DESCRIBE BRIEFLY. The study will be conducted on patients in nephrology department in selected hospitals at Bangalore. 7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTIONS IN CASE PATIENTS? Yes, Permission will be obtained from 1. Research committee of SUSHRUTHA COLLEGE OF NURSING, Bangalore. 2. Authorities of selected hospital. 8.LIST OF REFERENCES: 8.1BOOKS AND JOURANLS 1. Alex, M.D. Steward, C.J., Gunfield J.P., Ponticelli C., Pitz, E., Chistopher, GW., et al, (2005) Oxford text book of clinical nephrology (Ed.3) New York, Oxford University Press. 6(5),34-7. 2. Allen, R.N., and Richard, N.F. (2005). Clinical dialysis (Ed-4) New York, MC.Grew Hill company.8(5),890-96. 3. Banerjee, A., Knog C.H. & Farrington. K. (2004). The hemodynamic response to submamimal exercise during isovolemic hemodialysis, nephrology dialysis, transplant, 19 (12) 3204-5. 4. Bare, G.B., and Smetlzee, C.S. (2006). Brunner and Suddarth’s Text Book of medical and surgical nursing (Ed-10), Philadelphia: saunders. 800-8. 5. Barry M.B. (2004). Brenners and Rector’s The Kidney (Ed-7), Philandelphia: saunders. 6. Betty, M.J. and Pamela, B.W. (2005). A introduction to theory and resoning in nursing (Ed.2) Philadelphia: Lippincot.8(5),6-9. 7. Black M.J. and Jacobs, M.E (1996). luckmann and soresons’s medical surgical nursing (Ed-5) Philandelphia: saunders.906-913. 8. Brass, E.P., Adlex , S., Siestsema, K.E. Amato, A., and Hialt, W.R. (2002) Peripheral arterial disease is not associated with an increased prevelance of intradialytic cramps in patients on maintenance hemodialysis. As of nephrology 22(5-6).491-6. 9. Cappy, C.S. Joblonka, J., and Schroeder, E.T. (1999). The effect of exercise during hemodialysis on physical performance and nutrition assessment, Journal of renal nutrition 9(2) 63-70. 10. Cynthia, C.N. and Pamela, K.C. (1998). Joint structure and function a comprehensive analysis ( Ed-2) New delhi, Jaypee Brother.5(2),80-6. 11. De Paul, V., Moreland, J., Eager, T., and Clare, C.M.(2002) The effectiveness of anaerobic exercise and muscle strength training in patients receiving hemodialysis and Epo. American journal of kidney diseases 40 (6) 1219-29 12. Dirks, J. (2005) A world perspective on renal care, the challenges of prevention and treatment EPTNA ERCA journal, 31 (2), 72-4. 13. Kendall, P.F. Elizabeth, K.M., and Pratricia. G.P. (1993). Muscles testing and function (Ed-4). Philadelphia: Lippincott. 14. Gerard, J.T. and Nicholos, P.A. (1990). Principles of anatomy and physiology (Ed.6) New York: Harper and Row publisher. 15. Gutch, C.F., Martha, H.S., and Anna, L.C. (1993), Review of hemodialysis for nurses and dialysis personal (Ed.5)., Missouri: Mosby.4(2),60-68. 16. Hanen. J.S. (2005), treatment of protocol for cramps in ESRD. Medical library journal, 32(5), 5-7. 17. Howe, R.C., Wombolt, D.G., and Michie, D.D. (1978) . Analysis of tonic music activity and muscle cramps during hemodialysis. Journal of dialysis 2(1), 85-99. 18. John, T.D., Peter, G.B., and Todd, S.I (2003). Hand bood of dialysis (Ed-3) Phylandelphia: Lippincott. 19. Kannan, N., and Sawaya, R. (2001). Nocturnal leg cramps- clinically mysterious and painful but manageable, journal of Geriatrics, 6(6), 39-42. 20. Laura K.S., Elizebeth, L.W., and Lehmkuhl.L.D. (1996). Brunstrom’s clinical kinesiology. Phylandelphia: Lippincott. 21. Lederer, K.M., and Landry, F.J. (1996). Benign Nocturnal leg cramps current controversies over use of quinine. Post graduate medicine,9 (2) 177-8. 22. Lee, H.P., Park, S.L., Chin, L.Y., & Chi. H.Y.(1999). Management of intractable muscle cramps: the role of predilutional Hemofiltration, Dialysis & Transplantation Journal, 28(8), 456-60. 23. Mandal, A.K., Ahernathy, T., Ne;;iro, S.N. & stizel, V. (1995). Is quinine effective and safe in leg cramps? Journal of clinical pharmacology, 35 (6), 588-93 24. Pratheepavanich, P., Kupnieat, S.V., & Charoenske, T.. (1999). The relationship between myofacial trigger points of gastrocnemius muscle and nocturnal calf cramps. Journal of Thailand Medical Association, 82(5), 451-9 25. Tunry.R (2006). Problems associated with dialysis kidney patients news 8(8),20-7. 8.2 INTERNET REFERENCE www.healthybaccha.com/weaning_food www.greatoffers4u.com www.babycenter.in/baby/startingsolids/firstfood 9.SIGNATURE OF CANDIDATE : 10.REMARKS OF THE GUIDE : 11.NAME & DESIGNATION OF 11.1 GUIDE 11.2 GUIDE NAME AND ADDRESS 11.3 SIGNATURE OF THE GUIDE :MRS. B. RAJALAKSHMI,MS.C(N), ASST.PROFESSOR,MEDICALSURGICAL NURSING. :MRS. B. RAJALAKSHMI,MS.C(N), DEPT: MEDICAL SURGICAL NURSING. SUSRUTHA COLLEGE OF NURSING, #23 PAPAIAH GARDEN,DIAGNOAL ROAD, BSK III STAGE,CHANAMMANKERA ACHUKATTU, BANGALORE-560 085 : 11.4 HEAD OF THE DEPARTMENT : 11.5 SIGNATURE OF HOD 12.NAME OF THE PRINCIPAL : : MISS .A.R.BHARATHI MS.C (N) 12. SIGNATURE OF THE PRINCIPAL: 12.1. REMARKS OF THE PRINCIPAL: