In order to accomplish the objectives of this investigation, a single-blind experimental comparative design was implemented to evaluate the impact of intradialytic aerobic exercise and Incentive Spirometer on sleep quality and fatigue. Three experimental groups (aerobic exercise and Incentive Spirometer) and one control group were subjected to pre- and post-tests. Is there a difference in the levels of fatigue and sleep quality between hemodialysis patients who receive aerobic exercise and incentive spirometer therapy and those who do not receive it? Researcher will compare the levels of fatigue and sleep quality between hemodialysis patients who receive interventional therapy and those who do not receive it to see if interventional therapy works to relieve the fatigue and improve sleep quality. Participants will take aerobic exercise therapy group applied on the leg muscles for 20 minutes per session, and incentive spirometer group on respiratory muscles * Ask the patient to hold the breath as long as possible (at least five seconds) then exhale slowly. * Session was in the form of 30 times in sets, each set consist of 5-6 repetitions with rest 1 minute between sets , 3 times per week for total three month, during the first hour of each hemodialysis. sessions.
Irreversible loss of kidney function is known as chronic kidney failure, which can be fatal without dialysis or a kidney transplant . The incidence of chronic kidney disease (CKD) has been rising globally, leading to high rates of mortality, complications, and decreased quality of life. Currently, kidney problems affect more than 850 million people worldwide, and CKD is expected to rank fifth among the leading causes of premature death . Dialysis is a common treatment for chronic kidney disease (CKD), which accounts for more than 89% of end-stage renal disease (ESRD) patients worldwide . Although dialysis prolongs life, it also leads to significant disabilities, including decreased physical capacity, reduced daily functioning, fatigue, reduced mobility, poor sleep quality, and deterioration in overall health . One of the most common and disabling complaints among dialysis patients is fatigue, which impairs their cognitive, physical, and psychological abilities. Patients frequently report reduced ability to perform daily tasks, persistent fatigue, increased daytime sleepiness, and impaired attention . The prevalence of fatigue among dialysis patients ranged from 20% to 86% in a systematic review . Another common problem among dialysis patients is sleep disturbances, which significantly impact their quality of life. Poor sleep quality was reported by 68% of dialysis patients in a systematic review . Exercise is becoming increasingly important as a promising non-pharmacological treatment for improving heart and lung function in dialysis patients. Recent research suggests that physical activity enhances cardiovascular and physical function, as well as quality of life, in individuals undergoing maintenance dialysis. This leads to a positive cycle that includes improved mood, increased appetite, and increased food intake. Fatigue is defined as a persistent and severe state of tiredness that leads to mental or physical exhaustion, with a prevalence ranging from 60% to 97%. It is associated with a decreased quality of life and decreased survival rates . To recover, patients with post-dialysis fatigue must receive at least three hours of rest after each treatment session. Therefore, healthcare providers prioritize fatigue management as a treatment priority .Hemodialysis patients frequently experience sleep disturbances. The prevalence of sleep difficulties is estimated to range from 18% to 69%, with various forms, such as restless legs syndrome associated with obstructive sleep apnea. Sleep quality is the degree of satisfaction an individual feel with their sleep experience, which encompasses a variety of factors, including sleep rate, sleep duration, ability to stay asleep, and feeling refreshed upon awakening. Chronic fatigue, neurological changes, decreased self-care, and functional impairment are among the many problems that sleep deprivation can cause. Therefore, it is essential to prioritize sleep quality and address sleep deprivation in hemodialysis patients . A variety of pharmacological and non-pharmacological interventions can be beneficial for end-stage renal disease (ESKD) patients experiencing fatigue and sleep difficulties . A symptom cluster forms when fatigue and sleep problems converge, meaning they frequently occur simultaneously and exacerbate each other. The quality of life and functional independence of dialysis patients is significantly impacted by managing this cluster, which is a therapeutic priority . Currently, limited pharmacological options are available to alleviate symptoms in this population. Side effects, interference with dialysis treatments, or inadequate relief are common consequences of medications. As a result, non-pharmacological interventions have become globally recognized as cost-effective, safe, and practical strategies. Deep breathing, mindfulness, relaxation techniques, and exercise are among the most widely researched approaches . Clinical studies have demonstrated that aerobic exercise, particularly during dialysis, enhances dialysis efficiency, increases blood flow to muscles, removes toxins, and reduces inflammation . Aerobic exercise during dialysis has been shown to enhance cardiovascular function, reduce fatigue, and enhance overall health-related quality of life in clinical studies . Additionally, exercise can be performed during dialysis, as the patient does not need to spend a long period outside the dialysis center. Research has shown that deep breathing exercises are a beneficial complementary approach. Slow, purposeful breathing regulates the autonomic nervous system, increasing oxygenation, lowering blood pressure, and reducing sympathetic nervous system activity . Visually feedback-based incentive spirometers aim to enhance respiratory muscle training and reverse and prevent lung disorders, leading to prolonged inspiratory duration and lung expansion dynamics. The combination of inspiratory pauses and sustained maximal inspiration increases trans pulmonary pressure, which negatively impacts lung inflation. Nurses play a crucial role in assessing vital signs and managing pain, as they frequently and extensively interact with dialysis patients. Therefore, it is essential that they have the experience and skill to develop comprehensive nursing strategies specifically designed to address these concerns. Non-pharmacological techniques are frequently used in conjunction with pharmacological therapy to improve sleep quality and reduce fatigue during interventional procedures. Several studies have demonstrated the effectiveness of fatigue management during hemodialysis . Researchers are currently investigating the effect of a variety of non-pharmacological methods on fatigue and sleep quality. However, no specific study has been conducted to compare and analyze the effects of incentive spirometry and aerobic exercise on sleep quality and fatigue in hemodialysis patients. Research design In order to accomplish the objectives of this investigation, A four-arm, parallel-group randomized controlled trial was conducted among patients receiving maintenance hemodialysis in Diwaniyah, Iraq (aerobic exercise , Incentive Spirometer ,and combined) and one control group were subjected to pre- and post-tests. Randomization guarantees analogous groups, mitigates selection bias, and facilitates causal inferences regarding the efficacy of an intervention. Setting: The research sample of hemodialysis patients will be served by the Al-Diwaniyah Government Hospital, which includes the Al-Hayat Dialysis Center, Fatima Al-Zahraa Dialysis Center, Afak General Hospital Dialysis Center, and Al-Shamiya General Hospital Dialysis Center in Diwaniyah, Iraq. The selection of these centers was based on the availability of patients and the fact that patients are treated according to a specific schedule during dialysis, which enables researchers to closely monitor their progress. Sample and sampling: To ensure a transparent and scientifically based randomization procedure, a simple random sampling technique was used to select eligible adult patients with end-stage kidney disease receiving maintenance hemodialysis from the sampling frame. Following enrollment, participants were randomly allocated to either the control or intervention arm using a sealed-envelope method. Each participant selected one of two color-coded cards, with black indicating the control group and white indicating the intervention arm. Participants assigned to the intervention arm then selected one of three additional color-coded cards: red for the aerobic exercise group, green for the incentive spirometer group, and yellow for the combined intervention group. This random allocation procedure provided each eligible participant with an equal opportunity to be assigned to the study groups, thereby reducing selection bias and strengthening the internal validity of the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
169
The interventions were implemented during the first two hours of the hemodialysis session, starting 30 minutes after initiation. For intradialytic aerobic exercise, the cycle ergometer was placed on the bed, the patients' feet were secured to the pedals, and knee range of motion was assessed individually. pedaling was performed for 20 minutes at a speed of 30 rpm during each session, with instructions and verbal encouragement provided. Vital signs (blood pressure, heart rate, and body temperature) were monitored before, during, and after exercise. Regarding the use of the Incentive Spirometer, patients were seated upright and instructed to perform slow deep inhalation with breath holding for at least 5 seconds, followed by slow exhalation. Each session consisted of 30 repetitions divided into sets (5-6 repetitions per set) with a one-minute rest between sets. Exercise intensity was progressively increased according to the patient's condition. Training was conducted three weekly
University of Baghdad
Baghdad, Iraq
Fatigue assessment
Fatigue will be measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale. Higher scores indicate less fatigue.
Time frame: There will be three time points at which the measurement is assessed for both the study and the control group as follows: Pretest: At the first day Post-test 1:two weeks later . Post-test 2: four weeks later.
Sleep quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. A global PSQI score greater than 5 indicates poor sleep quality.
Time frame: There will be three time points at which the measurement is assessed for both the study and the control group as follows: Pretest: At the first day Post-test 1: two weeks later . Post-test 2: four weeks later.
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