Clinical Research Directory

The Effect of Home-Based Walking on Symptoms and Health Profile of Hemodialysis Patients

This study aims to evaluate the effect of 8 weeks of home-based moderate-speed walking on hemodialysis symptoms and health profile while patients are receiving hemodialysis treatment. Due to permanent deterioration in kidney function, patients need hemodialysis treatment, which is the most commonly used treatment method among renal replacement therapies. Hemodialysis treatment causes a series of physical and psychological problems. Problems such as hypotension, headache, nausea, muscle cramps, itching and pain are physical problems, while depression, anxiety, cognitive disorders and stress are psychological problems. In addition, it has been reported that long-term hemodialysis treatment and all the resulting problems increase the tendency to a sedentary lifestyle in this patient group, leading to a decrease in physical function and activity, and indirectly to a low quality of life and low survival rates. For this reason, hemodialysis patients have difficulty meeting their daily activities and needs, and their dependency and healthcare burden increase. Adopting a sedentary lifestyle by these patients prevents them from managing both the physical and psychological problems of hemodialysis and their conditions such as hypertension and diabetes mellitus, and causes the disease to progress. Physical exercises, which are considered among the useful therapeutic suggestions in addition to pharmacological treatments in the management of the negative situations that arise, are considered as an easy, useful and effective intervention method. Kidney Disease: Improving Global Outcomes (KDIGO) recommends 30 minutes of moderate-intensity physical exercise at least 5 days a week. Additionally, it should not be overlooked that whether patients have places to do physical activity and what their facilities are are a detail that should be questioned by health professionals. Patients without suitable accommodations should be encouraged to engage in physical activity, especially in indoor spaces like home. Home-based walking exercise is known to be easy, inexpensive, and safe, and is also advantageous when the weather is not favorable. When we examined the studies in which home-based walking exercise was performed, it was determined that its effect on functional capacity was generally investigated, but its effect on the health outcomes and symptoms of patients receiving hemodialysis treatment was not evaluated. There was no evidence that home-based walking exercise had any effect on symptoms in patients receiving HD treatment. Therefore, it was planned to conduct a study to evaluate whether home-based walking exercise has an effect on patient health outcomes.

Low-Level Laser Therapy Versus Isometric Handgrip Exercise On Arteriovenous Fistula Maturation in Hemodialysis Patients

The purpose of this study is to evaluate the effectiveness of low-level laser therapy (LLLT) compared with isometric handgrip exercise and standard care in promoting vascular remodeling of arteriovenous fistulas (AVFs) among hemodialysis patients.

Vibration Massage, Static Stretching Exercise, Intradialytic Muscle Cramps and Stress

Chronic kidney disease (CKD) is characterised by kidney damage that persists for 3 months or longer or an estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m² and is assessed in 6 categories. According to this categorisation, when stage 4 CKD progresses, patients are offered several options for renal replacement therapy. In the last stage of CKD, stage 5, renal replacement therapies including dialysis and kidney transplantation are used. Haemodialysis (HD) is a frequently used life-saving treatment method that removes harmful waste substances accumulated in the body, helps to maintain kidney function, provides fluid-electrolyte balance, prolongs life by managing uremic symptoms. Patients with ESRD are exposed to many health problems such as water-salt balance abnormalities, hypertension, hyperkalemia, metabolic acidosis, hyperphosphatemia, anaemia, cardiovascular disease. While the problems experienced are controlled with HD treatment, the treatment process and the continuation of life dependent on a machine cause life-threatening acute (hypotension, nausea, vomiting, muscle cramps, itching, pain, etc.) and chronic complications (pericarditis, hypertension, anaemia, hepatitis infections, etc.). In addition, due to these complications, HD patients may have problems that cannot be ignored such as deterioration in general health perception, sleep disturbance, anxiety, depression, stress, and difficulties in fulfilling responsibilities due to psychosocial problems. Intradialytic muscle cramp, which develops acutely during HD and is experienced at least once by patients, frequently manifests as involuntary muscle contractions in the lower extremities. The aetiology of intradialytic muscle cramp includes hypotension, electrolyte mineral disorders, high ultrafiltration (UF), excess weight gain between two HDs and carnitine deficiency. In the pharmacological treatment of this complication, which should be managed acutely, intravenous saline solution and hypertonic glucose administration are prominent, but high-quality evidence on the effectiveness of these treatments is needed. While the results of interventions such as aromatherapy, reflexology, massage, stretching-relaxation exercises, hot-cold applications etc. in intradialytic muscle cramp have been reached, the lack of evidence for vibration massage is striking. Management of intradialytic muscle cramp is important for the HD adequacy of patients and failure to manage it may lead to fatal complications such as hypertension, hypervolemia, pulmonary oedema and left ventricular failure due to inadequate HD sessions. It has also been reported that sleep and quality of life are adversely affected in cases where intradialytic muscle cramp cannot be managed; shortening of one HD session per week leads to increased mortality rates, depression and anxiety levels and stress. Salivary cortisol is a useful biomarker often used as a marker of psychological stress. Salivary cortisol levels peak approximately 20 minutes after an acute stress event. Massage, which is among independent nursing interventions, is a manipulation that provides physical and psychological relaxation by mechanically stimulating muscle tissues. During massage, nurses can apply euphlorage, petrissage, friction, tapotman and vibration. Vibration massage is applied to improve muscle atrophy and bone density caused by microgravity and immobilisation. Static stretching exercise, another intervention in intradialytic muscle cramp management, reduces muscle stiffness and tension by increasing muscle flexibility and range of motion by stimulating neural activities. These exercises reduce the risk of injury to joints, muscles and tendons by stimulating the formation of chemicals that allow the connective tissue to move easily and are recommended for the prevention of muscle cramps.

Effect of Pecha Kucha Education on Fluid and Diet Adherence in Hemodialysis Patients

This randomized controlled trial aims to evaluate the effect of education based on the Pecha Kucha presentation technique on fluid and dietary adherence in patients undergoing hemodialysis. Patients receiving hemodialysis often experience difficulties in adhering to fluid and dietary restrictions, which may lead to adverse clinical outcomes. The Pecha Kucha technique is a structured, visually supported presentation format designed to improve understanding and retention of information. In this study, patients in the intervention group will receive education using the Pecha Kucha method, while the control group will receive standard education routinely provided in the dialysis unit. The study will assess whether this innovative educational approach improves adherence to treatment and clinical parameters. The findings are expected to contribute to improving patient education strategies in hemodialysis care.

Comparative Study Between Leg Massage and Vibration on Cramps and Comfort for Patients Undergoing Hemodialysis

This planned randomized controlled trial will enroll 164 patients undergoing hemodialysis to compare the effectiveness of leg massage versus vibration therapy on muscle cramps and patient comfort. Participants will be randomly assigned to one of three groups: a massage group receiving 20-minute lower extremity massage sessions, a vibration group receiving 10-minute vibration therapy, or a control group receiving standard care only. All interventions will be administered three times per week for two weeks (six sessions). The study will evaluate cramp frequency, cramp severity using a Visual Analog Scale, sleep quality through the Pittsburgh Sleep Quality Index, and patient comfort scores. Both interventions are expected to significantly reduce cramp frequency and severity compared to standard care, with massage anticipated to show superior benefits for sleep quality and home-based cramp reduction, while vibration is expected to provide better immediate comfort during dialysis sessions. No serious adverse events are predicted. The findings will help healthcare providers offer personalized, evidence-based non-pharmacological options to improve quality of life for hemodialysis patients.

THE EFFECT OF MUSİC THERAPY IN HEMODİALYSİS PATİENTS

The aim of this study is to evaluate the effects of music therapy on pain intensity, anxiety levels, and hemodynamics (vital signs) in end-stage renal disease (ESRD) patients undergoing maintenance hemodialysis. This study employs a quasi-experimental design with a pretest-posttest control group, conducted among patients receiving routine hemodialysis treatment at the DaViVa Göztepe Dialysis Center. Participants in the intervention group receive music therapy applied in 30-minute sessions at the beginning of each hour throughout their hemodialysis treatments (specifically during vascular access/cannulation and dialytic sessions), while the control group receives standard nursing care. Objective physiological parameters along with validated subjective pain and anxiety scales are measured before and after the intervention to determine the therapeutic efficacy of music as a non-pharmacological nursing intervention.

Effect of Breathing Exercise on Intradialytic Hypotension in Hemodialysis Patients

Intradialytic hypotension is a common complication of hemodialysis that may adversely affect patient safety and treatment tolerance. This randomized controlled study aimed to evaluate the effect of a breathing exercise on the development of intradialytic hypotension (IDH) and hemodynamic stability in patients receiving hemodialysis and to determine the factors associated with the development of IDH. A total of 66 eligible patients were enrolled in the study and randomly assigned to the intervention and control groups. Six participants discontinued the study because of death, unwillingness to perform the breathing exercise, or unwillingness to continue participation. The study was completed with 60 patients. Patients in the intervention group performed the breathing exercise during hemodialysis sessions for four weeks and 12 sessions, while patients in the control group received routine care. Intradialytic hypotension and hemodynamic parameters were monitored throughout the study.

Liberalizing Potassium Restrictions in Patients Receiving Hemodialysis

People with end-stage kidney disease who receive hemodialysis are often told to strictly limit foods high in potassium, such as fruits, vegetables, legumes, nuts, and whole grains. This advice is intended to prevent high blood potassium levels (hyperkalemia), which can cause dangerous heart rhythm problems. However, these restrictions can make eating difficult, reduce diet quality, and lower quality of life. New research suggests that not all sources of potassium affect the body in the same way. Potassium added to highly processed foods is more easily absorbed than potassium naturally found in whole foods like fruits and vegetables. Large studies have found little evidence that eating potassium-rich whole foods increases blood potassium levels in people on dialysis. Clinical guidelines are beginning to shift, but no high-quality clinical trial has tested whether a more flexible, food-based approach is safe for people receiving hemodialysis. This study will compare two dietary approaches in 148 adults on hemodialysis: the usual low potassium diet and a "liberalized" potassium diet that encourages minimally processed foods while limiting highly processed foods with potassium additives. Participants will receive dietitian support and grocery assistance for 12 weeks. The investigators will closely monitor blood potassium levels to ensure safety. The investigators will also examine whether the liberalized diet is as safe as standard care, and whether it improves diet quality and quality of life. The investigators will also study factors that influence the participant's ability to follow the diet in real-world settings. If safe, this approach could reduce unnecessary food restrictions, improve diet quality, and enhance quality of life for people receiving hemodialysis, while maintaining patient safety.

Nurse-Led Dialysis Self-Management Program for Hemodialysis Distress

Hemodialysis patients may experience dialysis-related distress due to long-term treatment requirements, dietary and fluid restrictions, medication use, vascular access problems, dialysis-related symptoms, and psychosocial challenges. Nurse-led self-management programs may help patients improve dialysis self-management, reduce distress, and support treatment adherence. This study aims to evaluate the effect of a nurse-led needs-based dialysis self-management program on dialysis-related distress in patients receiving hemodialysis. The study will be conducted as a single-center, two-arm, parallel-group, randomized controlled trial. A total of 100 adult hemodialysis patients will be randomly assigned to either the intervention group or the control group in a 1:1 ratio. Participants in the intervention group will receive a 6-week nurse-led needs-based dialysis self-management program in addition to routine hemodialysis care. Participants in the control group will continue routine hemodialysis care. Data will be collected at baseline, 6 weeks, and 18 weeks. The primary outcome is dialysis-related distress. Secondary outcomes include illness and treatment uncertainty, treatment adherence, and clinical adherence indicators.

Prediction of Risk of Hypotension in Hemodialysis

The main objective is to establish a statistical predictive model of the risk of intradialytic hypotension during hemodialysis (HD) or hemodiafiltration (HDF) sessions based on the measurement of residual blood volume and excess extracellular hydration. The secondary objective is to study the impact of dysfunction in the mechanisms of compensation for decreased blood volume (heart disease, neuropathy, drugs) on the risk of intradialytic hypotension.

Efficacy of of Acupuncture Laser Therapy on Hemodialysis Patients

This expected prospective randomized control trial study will involve 60 haemodialysis patients with neck pain. The patients in the experimental group (E) will subject, medical treatment besides acupuncture laser therapy. Medical treatment will be used in the control group (C). Pain and quality of life assessment will be used in the assessment of outcome.

Assessment of the Impact of Repeated Ischemic Preconditioning Episodes on Hemodynamic and Metabolic Parameters in Patients at Various Stages of Chronic Kidney Disease

The aim of our study is to evaluate the impact of repeated episodes of ischemic quenching on changes in blood pressure, heart rate and laboratory parameters of inflammation in patients with kidney diseases. There is credible evidence that intentionally producing periods of ischemia provides protection of the myocardium and blood vessels against subsequent ischemic injury. The examination will be performed during hospitalization in the Department of Nephrology, Hypertension, Transplantology and Internal Diseases and will last 4 days. On the first day, blood pressure will be measured using an automatic blood pressure monitor, radial artery pulse, blood saturation will be measured using a pulse oximeter, and approximately 6 ml of venous blood will be collected from the elbow bend area for laboratory tests. Then, compression of the lower limb below the knee will be performed using a blood pressure cuff. Four 5-minute cycles of inflation and deflation of the cuff will be performed. The pressure on the lower limb will be repeated on the next two days. On the last day of the examination, blood pressure, heart rate and blood saturation will be measured again, and approximately 6 ml of venous blood will be collected again for laboratory tests.

Structured Nursing Education for Hemodialysis Patients

This randomized controlled trial was designed to evaluate the effects of a structured nurse-led education program on attitudes toward diet therapy, self-care activities, and chronic disease self-management among patients undergoing maintenance hemodialysis. Sixty eligible patients receiving maintenance hemodialysis were randomly assigned to either the intervention group (n = 30) or the control group (n = 30). Participants in the intervention group received a structured nurse-led education program consisting of eight face-to-face educational sessions delivered over four weeks (two sessions per week), while the control group received routine care without additional educational intervention. The primary outcomes were attitudes toward diet therapy, self-care activities, and chronic disease self-management, which were assessed before and after the intervention using the Hemodialysis Patients' Attitudes Toward Diet Therapy Scale (HPADTS), the Self-Care Activities Screening Scale-14 (SCAS-14), and the Chronic Illness Self-Management Scale (CISMS).

Virtual Reality Distraction for Pain and Anxiety in Hemodialysis Patients

1. Assess pain and anxiety levels in hemodialysis patients during arteriovenous fistula needle insertion. 2. Determine the effect of the distraction technique using virtual reality on pain and anxiety levels during arteriovenous fistula needle insertion in hemodialysis patients. 3. Find out the differences in the level of pain and anxiety after using virtual reality with regard to the demographic and clinical data of the sample.

CanSOLVE 2.0 Theme 3.1 Mind the Gap - Dialectical Behavioural Therapy (DBT) Skills Training Program Pilot

The goal of this pilot implementation study is to implement and evaluate a 13-week dialectical behavioural therapy (DBT) skills training program to address challenges to mental health and mental wellbeing in people who have recently started facility-based hemodialysis or those who may start within the next 6-12 months.

Effects of Intradialytic Nutrition on Dialysis Adequacy and Fatigue

This randomized, two-period, two-sequence crossover trial aims to evaluate the effects of intradialytic nutrition on dialysis adequacy, intradialytic hemodynamic parameters, and fatigue in adults receiving maintenance hemodialysis. Participants will receive standardized intradialytic nutrition during one study period and no food intake during the other period, with each participant serving as their own control. Dialysis adequacy will be assessed using the urea reduction ratio (URR) and single-pool Kt/V (spKt/V), while fatigue will be evaluated using the Piper Fatigue Scale. Intradialytic blood pressure and other clinical parameters will also be monitored throughout the study. The findings are expected to provide evidence regarding the safety and clinical effects of intradialytic nutrition and to support individualized nutritional management strategies for patients undergoing maintenance hemodialysis.

Cardiovascular and Bone Mineral Markers in Dialysis Patients and Healthy Controls

This observational study will compare cardiovascular status, bone mineral metabolism, systemic inflammation, body composition, functional status, quality of life, pruritus, and pain among patients receiving different renal replacement therapy modalities and healthy controls. Adult participants will be included in four groups: maintenance hemodialysis, continuous ambulatory peritoneal dialysis, automated peritoneal dialysis, and healthy controls. No new treatment, drug, dialysis modality, or experimental device will be assigned as part of the study. Participants will continue their routine clinical care. Serum interleukin-6 (IL-6), vascular cell adhesion molecule-1 (VCAM-1), fibroblast growth factor-23 (FGF-23), and sclerostin levels will be measured. Arterial stiffness will be assessed using pulse wave velocity (PWV), and body composition will be assessed using the Body Composition Monitor (BCM). Handgrip strength, quality of life, pruritus, and pain scores will also be evaluated. The study will also explore correlations between biochemical biomarkers, arterial stiffness, body composition, and patient-reported outcomes. In the automated peritoneal dialysis group, objective treatment adherence will additionally be assessed using the Sharesource (Baxter/Vantive) cloud-based remote patient monitoring platform.

Randomized Cross-Over Comparison of Medium Cut-Off and High-Flux Hemodialysis Membranes

Patients receiving maintenance hemodialysis are at increased risk of cardiovascular disease, chronic inflammation, endothelial dysfunction, and impaired quality of life. Medium cut-Off (MCO) hemodialysis membranes have been developed to enhance the removal of middle-molecular-weight uremic toxins compared with conventional high-flux membranes, which may improve inflammatory status and cardiovascular health. The aim of this study is to compare the effects of MCO and high-flux hemodialysis membranes on inflammatory biomarkers and cardiovascular function in adult patients receiving maintenance hemodialysis. The primary outcomes are changes in serum interleukin-6 (IL-6) and vascular cell adhesion molecule-1 (VCAM-1) levels. Secondary outcomes include arterial stiffness assessed by pulse wave velocity (PWV), body composition assessed by Body Composition Monitor (BCM), handgrip strength, and patient-reported outcomes including quality of life, pruritus, and pain scores. This is a prospective, randomized, open-label, two-sequence, two-period crossover study conducted at Gazi University Faculty of Medicine. Thirty adult hemodialysis patients will be randomized to one of two treatment sequences. Participants in Sequence A will receive MCO dialysis membranes for the first 3 months followed by high-flux membranes for the next 3 months. Participants in Sequence B will receive high-flux membranes for the first 3 months followed by MCO membranes for the next 3 months. Blood samples and clinical assessments will be performed at baseline, month 3, and month 6. The study is expected to provide evidence regarding the effects of different dialysis membrane technologies on inflammation and cardiovascular health and may contribute to optimizing membrane selection in routine hemodialysis practice.

Euvolemia-Based Assessment of Pulmonary Hypertension in Stable Hemodialysis Patients

Pulmonary hypertension (PH) is a frequent and clinically significant complication in patients with end-stage kidney disease (ESKD) undergoing maintenance hemodialysis (HD). However, PH assessment in this population is often confounded by volume overload, leading to potential overestimation and misclassification. This prospective, multicenter observational study aims to evaluate the prevalence, phenotype, and predictors of PH in HD patients under standardized euvolemic conditions. A structured pretrial phase including volume assessment and correction will be performed prior to echocardiographic evaluation, which will be conducted after confirmation of euvolemia, post-hemodialysis or on the following day. In participants with echocardiographic findings suggestive of PH, right heart catheterization may be performed when clinically indicated and after obtaining specific informed consent. The study integrates clinical, biological, dialysis-related, and echocardiographic data to provide a comprehensive characterization of PH in a well-defined ESKD population.

Arrhythmia in Hemodialysis Patients

Patients receiving dialysis for kidney failure suffer from very high rates of sudden cardiac death due to abnormal heart rhythms and perfusion defects associated with HD treatment. It has previously been recognized that patients suffer heart injury during the dialysis procedure which may be an important factor for investigation. The study uses a simple implantable device that can monitor heart rhythms over time to gather information on the type of abnormal rhythms that occur in dialysis patients. This information will be combined with ultrasound and x-ray scans of the heart that will also be collected. The goal is to understand the relationship between the abnormal rhythms and injury to the heart during dialysis and what causes these injuries. The information gathered in this study will be used to compare the accuracy of an in house personalized computational model to predict potential cardiac injuries when patients undergo HD treatment.

Music-Assisted Acupressure for Pain During AVF Cannulation in Hemodialysis Patients

This randomized controlled trial was conducted to evaluate the effect of music-assisted acupressure on pain experienced during arteriovenous fistula (AVF) cannulation in hemodialysis patients. The study was carried out with 72 patients receiving hemodialysis treatment three times per week via AVF in a state hospital in Gaziantep, Türkiye. Participants were randomly assigned to one of four groups: music-assisted acupressure, acupressure alone, music alone, and control group (routine care). The acupressure intervention was applied to the Hegu (LI4) point for approximately 3 minutes prior to needle insertion, while the music intervention consisted of listening to instrumental Classical Turkish Music in the Acemaşiran mode through headphones starting 5 minutes before cannulation and continuing until the end of the procedure. Pain intensity during AVF cannulation was measured using the Visual Analog Scale (VAS) during three consecutive dialysis sessions. The primary outcome was pain severity during needle insertion. The study aimed to determine whether combining music therapy and acupressure would provide greater pain relief compared to single interventions or routine care. Findings suggest that music-assisted acupressure may be an effective non-pharmacological nursing intervention for reducing procedural pain in hemodialysis patients.

Usefulness of the VExUS Protocol for Dry-Weight Adjustment in Hemodialysis Patients: The Multicenter VExHD Study

The objective of this prospective observational study is to determine the utility of ultrasonographic assessment using the VExUS protocol for dry weight adjustment in clinically euvolemic patients undergoing hemodialysis. The primary hypothesis is that the assessment of venous congestion by ultrasound may help identify patients who can tolerate increased ultrafiltration, thereby improving blood pressure control. The comparison group will consist of patients who do not meet the criteria for venous congestion according to the VExUS protocol. In patients meeting the criteria for venous congestion, the ultrafiltration volume during hemodialysis will be increased.

The Application of Art Therapy to Patients Undergoing Hemodialysis Treatment

Purpose of the Study: This study aims to investigate the effect of art therapy on anxiety and psychological resilience levels in Chronic kidney disease(CKD) patients undergoing hemodialysis patients. Hemodialysis patients undergo long-term treatment, often experiencing psychological issues such as anxiety and depression, which significantly reduce their quality of life. Among non-pharmacological approaches to alleviate these symptoms, art therapy has gained increasing attention. Art therapy helps patients shift their focus away from their illness, fosters self-confidence, reduces anxiety, and promotes relaxation .

Health Belief Model-Based Education for Pruritus and Quality of Life in Hemodialysis Patients

This study evaluates the effect of a Health Belief Model (HBM)-based educational intervention on pruritus severity and pruritus-related quality of life (QoL) in hemodialysis patients. The cluster-randomized controlled trial includes hemodialysis patients allocated to an intervention group and a control group. The intervention group receives two face-to-face HBM-based education sessions at 15-day intervals supported by a structured booklet, while the control group receives standard care. Pruritus outcomes and quality of life are assessed using the 5-D Itch Scale and ItchyQoL to determine the effectiveness of theory-driven educational frameworks in routine nursing care and patient-centered outcomes.