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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-01

Study Completion Date

2020-02-28

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.

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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:

1. To investigate the thermoregulatory responses of hemodialysis patients under four different hemodialysis protocols.
2. To assess the changes in muscular architecture and functional capacity in dialysis patients after 7 months of intradialytic exercise training.
3. To assess the impact on insulin sensitivity and glucose disposal.

Conditions

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End Stage Renal Failure on Dialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard Dialysis

Patients participated in a 7 months exercise trials receiving standard dialysis (at 37oC)

Group Type PLACEBO_COMPARATOR

Typical Dialysis

Intervention Type PROCEDURE

Dialysate temperature is set at 37oC for a period of 7 months

Exercise

Intervention Type PROCEDURE

Aerobic Intradialytic exercise training

Cold Dialysis

Patients participated in a 7 months exercise trials receiving cold dialysis (at 35oC)

Group Type EXPERIMENTAL

Cold Dialysis

Intervention Type PROCEDURE

Dialysate temperature reduced to 35oC for a period of 7 months.

Exercise

Intervention Type PROCEDURE

Aerobic Intradialytic exercise training

Interventions

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Cold Dialysis

Dialysate temperature reduced to 35oC for a period of 7 months.

Intervention Type PROCEDURE

Typical Dialysis

Dialysate temperature is set at 37oC for a period of 7 months

Intervention Type PROCEDURE

Exercise

Aerobic Intradialytic exercise training

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No