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NCT Number: NCT03905551

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

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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Key information

Conditions

End Stage Renal Failure on Dialysis Behavior Fatigue Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Patsidis General Clinic, Larissa, Thessaly, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cold Dialysis

Procedure

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

Typical Dialysis

Procedure

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

Exercise

Procedure

Aerobic Intradialytic exercise training

Primary outcomes

  1. Change in Body Heat Storage

    Time frame: Changes from baseline at 7 months

    Body Heat storage will be assessed during the 4 hours of dialysis under the two main conditions. Body Heat Storage is calculated in Watt

  2. Change in Insulin Resistance

    Time frame: Changes from baseline at 7 months

    Insulin resistances will be assessed by an Oral Glucose Tolerance Test using the OGIS index

  3. Change in Muscle Size

    Time frame: Changes from baseline at 7 months

    Muscle size will be assessed using Ultrasonography

Secondary outcomes

  1. Change in Quality of life score

    Time frame: Changes from baseline at 7 months

    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

  2. Change in Functional Capacity

    Time frame: Changes from baseline at 7 months

    Functional capacity will be assessed by the 6 min walking test

  3. Change in Daily Physical activity

    Time frame: Changes from baseline at 7 months

    Daily physical activity will be assessed by a 7 day recall pedometer

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Collaborators

  • National and Kapodistrian University of Athens

Registry information

Official study title

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

Acronym: REACD

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Apr 5, 2019
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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