Impact of Cold Dialysis in Combination With Intradialytic Exercise in Aspects Related to Quality of Life and Health

Study Overview
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Brief Summary
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Despite the tremendous advances in dialysis technology, hemodialysis (HD) is a significant challenge for dialysis patients and quality of their lives[2]. Research has shown for years that dialysate fluid temperature and especially the typical dialysis (TD) temperature at (37°C) are complicated by hemodynamic instability which leading to an increased risk of heat-induced hypotension causing patient discomfort and increased mortality. Cold dialysis (CD) is defined as the reduction of dialysis fluid temperature to 35-36°C, approximately 1°C below the typical dialysate temperature which ranges between 37-38°C. A number of studies have reported beneficial effects of CD on maintaining hemodynamic stability, minimizes hypotension and exerts a protective effect over major organs including the heart and brain. In addition, current evidence showed the protective effect of CD in cardiac performance during the dialysis session. As the investigators know until today cardiovascular mortality is an important issue for nephrologists that care for ESRD patients, however, many other benefits have been observed on patients' overall health and quality of life levels by used of CD. The above-mentioned benefits of CD in the hemodynamic stability and the general quality of life of the patients are highlighted even further due to the ever-increasing adoption of intradialytic exercise programs. It has been well established that intradialytic exercise leads to benefits of physiological, functional, and psychological deterioration, which commonly accrues as a consequence of biological aging, catabolic illness, and a sedentary lifestyle, factors that may all contribute to the progressive decline of vitality and quality of life commonly observed in ESRD patients. However, despite a strong rationale for the implementation of intradialytic exercise programs and the aforementioned benefits of CD, the separate and combined effects of these protocols in aspects related to quality of life and health in ESRD patients have not been investigated to date. The aim of the current clinical study was to assess the effect of exercise rehabilitation regimes in combination with changes in dialysate temperature in aspects related to quality of life and health in end-stage renal disease patients receiving hemodialysis.

Detailed Description
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The primary aim of the clinical study was to investigate the combined effect of cold dialysis and aerobic exercise in aspects related to health. More specific: To investigate the thermoregulatory responses of hemodialysis patients under four different hemodialysis protocols. To assess the changes in muscular architecture and functional capacity in dialysis patients after 7 months of intradialytic exercise training. To assess the impact on insulin sensitivity and glucose disposal.

Official Title
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The Effect of Exercise Rehabilitation Regimes in Combination With Changes in Dialysis Procedures in Aspects Related to Quality of Life and Health in End Stage Renal Disease Patients

Conditions
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End Stage Renal Failure on Dialysis

Intervention / Treatment
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* Procedure: Cold Dialysis
* Procedure: Typical Dialysis
* Procedure: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically stable ESRD patients receiving regular hemodialysis treatment for at least 3 months, adequate dialysis delivery Kt/V >1.1 good compliance of dialysis treatment serum albumin >2.5 g/dL hemoglobin ≥11g/dL. Exclusion Criteria: Patients with a reason to be in a catabolic state, hyperthyroidism, active vasculitis, malignancies, pregnancy HIV, opportunistic infections, musculoskeletal contraindication to exercise, requirement for systemic anticoagulation, participant or participated in an investigational drug or medical device study within 30 days, active inflammations, that required intravenous antibiotics within 3 months prior to enrollment, diabetics receiving insulin therapy, New York Heart Association grade IV heart failure, mental incapacity to consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The current study is a randomized clinical trial lasting for 7 months. Hemodialysis patients, which fulfilled the inclusion criteria, randomly divided into two groups: a) typical dialysis with dialysate temperature at 37°C (TD+EX) in combination with aerobic intradialytic exercise training, b) cold dialysis with dialysate temperature at 35°C (CD) in combination with aerobic intradialytic exercise training (CD+ET). Patients enrolled by a research assistant assigned into the study while the order that the patients assigned to the first scenario was randomly using a computer random number generator.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard Dialysis<br>Patients participated in a 7 months exercise trials receiving standard dialysis (at 37oC) | Procedure: Typical Dialysis<br>* Dialysate temperature is set at 37oC for a period of 7 months<br>Procedure: Exercise<br>* Aerobic Intradialytic exercise training<br>|
| Experimental: Cold Dialysis<br>Patients participated in a 7 months exercise trials receiving cold dialysis (at 35oC) | Procedure: Cold Dialysis<br>* Dialysate temperature reduced to 35oC for a period of 7 months.<br>Procedure: Exercise<br>* Aerobic Intradialytic exercise training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Heat Storage | Body Heat storage will be assessed during the 4 hours of dialysis under the two main conditions. Body Heat Storage is calculated in Watt | Changes from baseline at 7 months | 
| Change in Insulin Resistance | Insulin resistances will be assessed by an Oral Glucose Tolerance Test using the OGIS index | Changes from baseline at 7 months | 
| Change in Muscle Size | Muscle size will be assessed using Ultrasonography | Changes from baseline at 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of life score | Quality of life will be assessed using the Sort Form 36 questionnaire. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is consisted of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health | Changes from baseline at 7 months | 
| Change in Functional Capacity | Functional capacity will be assessed by the 6 min walking test | Changes from baseline at 7 months | 
| Change in Daily Physical activity | Daily physical activity will be assessed by a 7 day recall pedometer | Changes from baseline at 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cold dialysis, intradialytic exercise, insulin resistance, thermoregulation, muscle architecture, quality of life, fitness, fatigue, physical activity