INTRODUCTION:

Chronic kidney disease is a worldwide public health problem, a social calamity and an economic catastrophe. It is an important non-communicable disease epidemic that affects the world population including India. The prevalence of end stage renal disease (ESRD) is rising throughout the developed and developing countries mainly due to diabetes mellitus and hypertension.¹

Ames Gross (2013), nearly ten percent of India’s 1.24 billion people suffer from chronic kidney disease (CKD), a disease in which the kidney slowly loses function and fails. One survey (2013) found that more than 15 percent of urban Indians have the disease, with rates almost 50 percent in some cities. As the number of CKD patients goes up, so has the size of the Indian dialysis market. It increased in value to more than $150 million in 2012, from $100 million in 2007. India‟s demand for dialysis is growing at a rate of 31 percent, compared to 6 percent in the US and 8 percent in the rest of the world.²

Prevalence of the disease also varies by region in India. Urban areas have much higher rates than rural areas, and Northern India has higher rates than Southern India. For example, New Delhi had a CKD rate of more than 40 percent in 2013, while Mysore and Bangalore had rates of about 4 percent (Ames Gross 2013).²World Health Organisation (WHO) 2013, Global Burden of Disease Project, disease of the kidney and urinary tract contribute to approximately 850,000 deaths every year of which chronic kidney disease (CKD) is the 12^th leading cause of death and the 17^th leading cause of disability in the world.³ As per the reports of European Dialysis and Transplant Nurses Association, there are currently 10,65,000/- people on hemodialysis worldwide (European renal care association journal, 2005).⁴

Research Foundation (2006), Tamilnadu found that 10 lakh people suffer from kidney failure and more than four crores are at risk. CKD will kill 36 million people by the year 2015.⁴

An Indian population –based study determined the crude and age-adjusted ESRD incidence rates at 151 and 232 per million population, respectively. If validated in other parts of this region, it would mean that about 220,000-275,000 new patients need Renal replacement therapy every year in this part of the world. It is estimated that there are about 55,000 patients on dialysis in India, and the dialysis population is growing at the rate of 10-20% annually.⁵

Dialysis saves lives. Muscle cramps are a common complication during dialysis treatments. Leg muscles are commonly affected. Less common muscles that may include the hands, arms and abdomen. Cramps occur in 33 to 86% of patients; they often result in early termination of a hemodialysis session and are therefore a significant cause of under dialysis. The exact cause of cramps in dialysis is unknown. (Paul Kellerman, MD).⁶

However, dialysis alone cannot make those lives active and meaningful. Measures should be employed to improve the physical well-being of the patient. Exercise is crucial in the rehabilitation of many individuals with chronic renal insufficiency. Patients with ESRD have lower physical activities, muscle performance and quality than do healthy subjects. Numerous studies have suggested that exercise could improve many indicators of physical functioning improve self-reported physical functioning and also improve quality of life (QOL) in ESRD patients. In addition, considering that cardiovascular disease is the major cause of death in patients with advanced CKD, exercise and regular physical activity have the potential to reduce the cardiovascular mortality in ESRD.⁷

Holley (2011), Almost all patients complain of muscle cramps at one or other time during dialysis usually of lower extremities that too of calf muscle. Muscle cramps may have serious consequences for patients who experiences them. Muscle cramps can be painful and this may impact quality of life. Cramps may also limit a patients ability to tolerate dialysis and therefore, contribute to under dialysis or chronic fluid overload. Patients who experiences cramps associated with dialysis have been reported to have higher serum creatinine phosphobinase values (suggesting muscle Injury) than patients who do not experience cramps.⁶

Muscle cramps (involuntary muscle contraction associated with severe pain) occur frequently in patients receiving dialysis. Muscle cramps can involve the legs, most commonly in the feet, but can also involve arms and hands, as well as abdominal muscles (Holley, 2011; Kobrin and Berns, 2007).⁸ It is estimated that 33% to 86% of patients receiving dialysis have experienced cramps. In a study from 2001, 25% of hemodialysis patients reported two or more intra-dialytic cramps weekly (Khajehdhi, Mojerlou, Behzadi, and Rais-Jalali, 2001).⁸

Zahra Abbasi (2013), studied the effect of intra-dialytic stretching exercises on severity of symptoms of restless legs syndrome RLS and quality of sleep in hemodialysis patients. In this, the patients in exercise group performed a 30minutes stretching exercise on legs, three times a week, during the last two hours of hemodialysis session for 8 weeks. As per the study, intra-dialytic stretching exercises are effective in reducing Restless Legs Syndrome symptoms and improving quality of sleep in hemodialysis patients, in same way intra-dialytic stretching exercises would also be effective on relieving muscle cramps among patients undergoing hemodialysis.⁹

Deane Mastnardo (2014) in Institutional Review Board at Metro Health Medical Centre, Toronto conducted a study on 32 (16 intervention, 10 control) hemodialysis patients with frequent lower extremity cramps were enrolled in study. Frequent cramping during dialysis treatment was defined as one or more episodes of lower extremities, during or after dialysis over the previous two weeks. The intervention group received a 20 minutes massage of the lower extremities during each treatment (3times/week) for two weeks. The control group received usual care by dialysis center staff. Results showed patients reported cramping at home decreased by 2.5 in the intervention group, compared to 0.3, control group (p=0.005) and patients reported cramping during decreased by 1.6 in the intervention group, compared to 0.9 in the control group(p=0.44).¹⁰

From above mentioned studies, it is cleared that muscle cramps are common problem faced by hemodialysis patients. 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 programmes are thought to be better incorporated into dialysis session. But in case of stretching exercises, the patients positions in bed during dialysis prevent self- stretching. Thus, this study is opted to provide passive calf stretching exercises prophylactically during hemodialysis to relieve or prevent muscle cramps. Through this study, a researcher wants to assess the effect of intra-dialytic stretching exercises on muscle cramps to improve quality of life in ESRD patients.

OBJECTIVES:

1. To assess the level of muscle cramps among patients undergoing hemodialysis in control and experimental group.

2. To reassess the level of muscle cramps without intervention (intra-dialytic stretching exercises) in control group and after performing intervention in experimental group.

3. To compare the effectiveness of intra-dialytic stretching exercise on muscle cramps among hemodialysis patients in control and experimental group.

4. To find out the association between the level of muscle cramps among patients undergoing hemodialysis and selected socio-demographic variables.

Hypothesis:

H₀- There is no significant effect of intra-dialytic stretching exercise on muscle cramps among patients in control group as compared to experimental group.

H₁- There is significant effect of intra-dialytic stretching exercise on muscle cramps among patients in experimental group as compared to control group. Conceptual framework adopted in this study was Imogene Kings Open system model.

MATERIAL AND METHODS:

Research design:

A quantitative approach and quasi experimental (non-equivalent pre-test and posttest control group) research design used in the study.

Research Setting:

S.G.L Hospital and India Kidney Hospital, Jalandhar.

Population:

It consisted of patients undergoing hemodialysis in S.G.L charitable hospital and India kidney hospital of Jalandhar.

Target population:

It consisted of patients suffering from muscle cramps during previous hemodialysis session in S.G.L Charitable Hospital and India kidney Hospital Jalandhar.

Sample:

60 patients undergoing hemodialysis and purposive sampling technique.

Criteria for sample selection:

Inclusion Criteria:

1. All adult patients undergoing hemodialysis between the age group of 18-65 years.

2. Patients who were able to understand Punjabi, English or Hindi.

3. Patients who were willing to participate.

4. Patients who already experienced muscle cramps during hemodialysis.

5. Patients attending hemodialysis 2 times per week.

Exclusion Criteria:

1. Patients with burns and ulcers in lower limbs.

2. Patients who had evidence of recent acute coronary syndrome, uncontrolled hypertension, neurological or cognitive disorders with functional deficits, musculo-skeletal diseases (knee fractures, osteoarthritis etc.)

Variables for the study:

Independent Variable- Intra-dialytic stretching exercises.

Dependent Variable- Muscle cramps among patients undergoing hemodialysis.

Selection and Development of Tool:

Selection and development of tool was done based on the objectives of the study. Content validity for the leg cramp assessment scale and Intra-dialytic Stretching Exercises were prepared on the basis of review of literature, internet, searching books and guidance of experts. The content matter of research tool and exercises was translated into Punjab as per the convenience of sample.

Description of Tool:

Tool was divided into three sections:

Section: 1- Socio-Demographic Variable:

It consisted of questions regarding socio-demographic profile of the patients: age, gender, residence, occupation, religion, family income per month, history of substance abuse, duration of diagnosis of renal failure (in years), number of hemodialysis cycle per week, weight of fluid removed during dialysis, previous experience of leg cramps during dialysis, site of A.V fistula and medication.

Section: 2- Leg Cramp Assessment Scale:

It consisted of leg cramp assessment scale to assess the level of muscle cramps. Leg cramp assessment scale consisted of the following-Tool to assess the occurrence of number of leg cramps, the average duration of leg cramp and the modified numerical intensity scale to assess the intensity of leg cramps which has 0-10 readings with the maximum possible Grade of III and minimum possible Grade of 0. It is graded as follows:

GRADE	SCORING
Grade 0	0
Grade I	1-3
Grade II	4-6
Grade III	7-9

Maximum score :9 Minimum score :0

Section:3-procedure for intra-dialytic stretching exercises Validity of tool:

The content validity of the tool and intervention was established after consultation with experts from the field of Medical Surgical Nursing, Physiotherapy and Medical Department. The suggestions were incorporated on the basis of recommendations and suggestions of experts after consultation with research Supervisor. The tool was found to be valid and suitable for assessment of effect of intra-dialytic stretching exercises on muscle cramps among patients undergoing hemodialysis.

Pilot Study:

The pilot study was conducted in the month of December, 2015 in New Ruby hospital Jalandhar after taking written permission from the higher authorities. It was conducted on 12 patients in which 6 were considered in control group and 6 in experimental group.

Reliability of Tool:

It is the degree of consistency or dependability with which an instrument measures the attributes to which it is intended to measure. The leg cramp assessment scale is used. The reliability of tool (leg cramp assessment scale) was 0.89 which shows tool is reliable for research study.

Ethical Considerations:

1. Written permission was taken from Principal S.G.L Nursing College Semi, Jalandhar Punjab.

2. Ethical clearance was taken from ethical clearance committee of the S.G.L Nursing College Semi, Jalandhar, Punjab.

3. Written permission was taken from Medical superintendent of S.G.L Hospital and Managing Director of India Kidney Hospital, Jalandhar.

4. Written informed consent was taken from patients for the study sample.

5. Confidentiality and anonymity of each study sample was maintained throughout the study.

Data Collection Procedure:

1. The data was collected in the month of March, 2016 by taking permission from the Principal, S.G.L Nursing college, Semi, Jalandhar.

2. The investigator, prior to commencing the task of data collection obtained wriiten permission from Medical Superintendent of S.G.L charitable hospital Jalandhar and Managing Director of India Kidney hospital, Jalandhar.

3. Patients who had previous experience of muscle cramps during hemodialysis were grouped into control and experimental group.

4. Information was given to the samples about imposed research study and written consent was obtained for participation in the study.

5. The pretest of both groups i.e, control and experimental group was done by assessing the level of muscle cramp with leg cramp assessment scale. In experimental group, patients who had previous experience of muscle cramps were provided with Intra-dialytic stretching exercises at the end of second hour of hemodialysis cycle. It includes regular stretching and relaxing of calf muscle and gently bending the knees upward towards the chest level and keeping the feet flat on surface of bed by holding it for 10 seconds, repetition of this for 5 minutes period followed by 5 minute interval and subjects are asked to report on the occurrence of muscle cramps. At the end of each hemodialysis cycle post- test assessment of muscle cramps for both groups(control and experimental) was done by using leg cramp assessment scale.

Plan of Data Analysis:

Data analysis and interpretation was done according to the objectives of the study. Analysis was done by using descriptive and inferential statistic. Descriptive statistic used was Frequency, Percentages, Mean and Standard Deviation. In Inferential statistict‟ test(unpaired t‟ test) and ANOVA test (F value) were used for finding the association with the socio demographic variables in experimental and control group.

Table 1 revealed the comparison of mean pretest and mean posttest level of muscle cramps among hemodialysis patients in control and experimental group. In control group, there was significant (t_cal6.500 at p<0.05) difference between mean pretest and mean posttest grade of muscle cramps. In experimental group, there was highly significant (t_{cal 14.698} at p<0.05) difference between mean pretest and mean post test grade of muscle cramps. There was significant (t_cal4.746 at p<0.05) difference in mean posttest grade of muscle cramps between control and experimental group. Hence the Research hypothesis (H₁) is accepted and Null hypothesis (H₀) is rejected. So it is concluded that intra-dialytic stretching exercises had significant effect on muscle cramps among patients undergoing hemodialysis at p<0.05 level.

Major Findings:

Ÿ From the data analysis it was concluded that in control group, 13(43%) respondents were in 50-65 age group followed by 11(37%) respondents in34-49 years. Whereas in experimental group, majority of respondents 12(40%) were in 34-49 age group followed by 9(30%) in both 18-33 and 50-65 years.

Ÿ Majority of respondents were female 16(53%) in control group whereas 19(63%) respondents were male in experimental group.

Ÿ As per residence, in control group majority of respondents were belong to rural area 17(57%) whereas in experimental group ratio of rural and urban residence was same i.e, 15(50%) in both.

Ÿ In control group, majority of respondents 17(57%) were skilled where as in experimental group, 18(60%) respondents were unskilled.

Ÿ According to religion, in both groups majority of respondents belongs to Hindu religion i.e, 14(47%) in control group and 14(47%) in experimental group.

Ÿ In both groups, majority of respondents 16(54%) in control group and 11(37%) in experimental group had 10,001-15,000 family income per month.

Ÿ As per history of substance abuse, majority of respondents in both groups, in control group 27(90%) and in experimental group 26(87%) were abuse to no substance.

Ÿ According to duration of diagnosis of renal failure, in control group majority of respondents 19(63%) had renal failure diagnosis in 3-6 years whereas in experimental group more respondents 17(57%) had renal failure diagnosis>6 years.

Ÿ In both groups, majority of respondents 30(100%) in control group and 30(100%) in experimental group went for hemodialysis twice a week.

Ÿ According to weight of fluid removed during dialysis, in both groups the majority of respondents in control group 15(50%) and in experimental group 14(47%) went for 4.5 liters of fluid removal during dialysis.

Ÿ In both groups, majority of respondents in control group 17(57%) and in experimental group 20(67%) had radiocephalic site of A.V fistula.

Ÿ According to medication, majority of respondents 27(90%) took medication to prevent muscle cramp in control group and 28(93%) respondents did not take medication to prevent muscle cramps in experimental group.

Ÿ The mean pretest grade of muscle cramps in control and experimental group were 6.20±1.27 and 6.73±1.21 respectively. The mean post test grade of muscle cramp in control and experimental group were 5.33±1.18 and 3.63±1.56 respectively. It indicated that there is significant reduction in grade of muscle cramps among patients undergoing hemodialysis in experimental group as compared to control group.

Ÿ There was no significant difference between the mean pretest grade of muscle cramps in control and experimental group (tcal=1.652 at p<0.05). There was significant difference between mean posttest grade of muscle cramps in control and experimental group (tcal= 4.746* at p<0.05). Hence the research hypothesis (H1) is accepted and Null hypothesis (H0) is rejected. So it is concluded that the intra-dialytic stretching exercises had significant effect on muscle cramps among patients undergoing hemodialysis.

Ÿ According to socio demographic variables, age (F=5.021, df= 2/27), Family income per month (F=4.275, df=3/26) and weight of fluid removed during dialysis (F=2.995, df=6/23) found to be associated with muscle cramps. The increasing age is associated with muscle cramps may be due to decrease muscle strength with increased age and elevation of serum creatinine kinase may lead to an abnormal utilization of energy by muscles and thus results in muscle cramps. Family income per month is associated with muscle cramps may be because who has good family income can get medication to prevent muscle cramp during each hemodialysis cycle and weight of fluid removed during dialysis was found to be associated due to excessive ultrafiltration and electrolyte mineral disturbance. Other causes which may be associated with muscle cramps includes changes in plasma osmolality and intra-dialytic hypotension.

DISCUSSION:

The findings of the study were supported by Roberto Bullani et. al. (2011) who conducted a study to assess the effect of intra-dialytic stretching exercises on physical function in patients on maintenance Hemodialysis.

The results of the study described that age (F=5.021, df= 2/27), Family income per month (F=4.275, df=3/26) and weight of fluid removed during dialysis (F=2.995, df=6/23) found to be associated with level of muscle cramps. The increasing age is associated with muscle cramps may be due to decrease muscle strength with increased age and elevation of serum creatinine kinase may lead to an abnormal utilization of energy by muscles and thus results in muscle cramps. Family income per month is associated with muscle cramps may be because who has good family income can get medication to prevent muscle cramp during each hemodialysis cycle and weight of fluid removed during dialysis was found to be associated due to excessive ultrafiltration and electrolyte mineral disturbance. Other causes which may be associated with muscle cramps includes changes in plasma osmolality and intra-dialytic hypotension.

CONCLUSION:

Findings of the study revealed that the mean pretest grade level of muscle cramps in control and experimental group were 6.20±1.27 and 6.73±1.21 respectively. The mean posttest grade level of muscle cramp in control and experimental group were 5.33±1.18 and 3.63±1.56 respectively. It indicated that there is significant reduction in grade level of muscle cramps among patients undergoing hemodialysis in experimental group as compared to control group. So, the present study concluded that intra-dialytic stretching exercises had significant effect on muscle cramps among patients undergoing hemodialysis.

REFERENCES:

1. Smeltzer C. S et. al. Brunner and Suddarths Textbook of Medical-Surgical Nursing Vol-2 12^{t h} Edition New Delhi: Wolters Kluwer, 2002.

2. Ames G .India’s Dialysis Market :http;www.pacificbridgemedical.com/publications/ high-rates-of-chronic-kidney-disease-lead-to-medtech-opportunities-in-india. Reviewed on-29/12/2014

3. Arrige S, Giuseppe R. Chronic renal diseases as a public health problem: Epidemiology, social and economic implications in Italy http://www3who.int/whois/menu.cfm?path=evidence burden and language=English. Reviewed on-5/12/2014

4. Pandluru G. A Pre-experimental study to assess the effect of intra-dialytic stretching exercises on muscle cramps among patients undergoing Hemodialysis in selected Hospitals at Kolar District-Karnataka, 2012. Cited from:www.rguhs.ac.in /cdc/onlinecdc/ uploads/05 _N199_ 8196.doc/ Reviewd on-15/11/2014

5. Modi GK, Jha V. The incidence of end-stage renal disease in India: a population based study. Kidney Int 2006;70:2131-2133.http://www.nature.com/kisup/journal/13/n2/full/kisup 20133a.html. Reviewed on-6/12/2014.

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8. Holley, Kokein and Berns. Treatment of leg cramps in patients with chronic kidney disease receiving hemodialysis. http://www.thefreelibrary.com/patients+with+chr patients+with+chronic+kidney+disease.a0267334035. Reviewed on-20/12/2014

9. Zahra A. The effect of intra-dialytic stretching exercises on severity of symptoms of RLS and quality of sleep in hemodialysis patients in Tehran. http://fnm.turms.ac.ir/userfiles/Abbasi_Z.pdf. Reviewed on-29/12/2014

10. Deane M.A study was done on hemodialysis patients with frequent lower extremity cramps. reviewed on- 12/02/2015.

11. Roberto Bullaniet. al. To assess the effect of intra-dialytic stretching exercises on physical function in patients on maintenance Hemodialysis. http://www.jrnjournal.org/article/S1051-2276(10)00286-4/abstract. Reviewed on-20/4/2016

Received on 26.03.2019 Modified on 11.04.2019

Int. J. of Advances in Nur. Management. 2019; 7(2):97-102.

DOI: 10.5958/2454-2652.2019.00025.8

GROUP	CONTROL GROUP			EXPERIMENTAL GROUP
	Mean	SD	Mean	SD	df	t test
Pretest	6.20	1.27	6.73	1.21	58	1.652
Posttest	5.33	1.18	3.63	1.56	58	4.746*
		t =6.500			t =14.698*
		df=29			df=29