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Trial record 1 of 1 for:    NCT03905551
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Impact of Cold Dialysis in Combination With Intradialytic Exercise in Aspects Related to Quality of Life and Health (REACD)

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ClinicalTrials.gov Identifier: NCT03905551
Recruitment Status : Unknown
Verified April 2019 by Giorgos K. Sakkas, University of Thessaly.
Recruitment status was:  Active, not recruiting
First Posted : April 5, 2019
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
National and Kapodistrian University of Athens
Information provided by (Responsible Party):
Giorgos K. Sakkas, University of Thessaly

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
End Stage Renal Failure on Dialysis Procedure: Cold Dialysis Procedure: Typical Dialysis Procedure: Exercise Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official 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
Actual Study Start Date : February 1, 2015
Actual Primary Completion Date : June 29, 2018
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Standard Dialysis
Patients participated in a 7 months exercise trials receiving standard dialysis (at 37oC)
Procedure: Typical Dialysis
Dialysate temperature is set at 37oC for a period of 7 months

Procedure: Exercise
Aerobic Intradialytic exercise training

Experimental: Cold Dialysis
Patients participated in a 7 months exercise trials receiving cold dialysis (at 35oC)
Procedure: Cold Dialysis
Dialysate temperature reduced to 35oC for a period of 7 months.

Procedure: Exercise
Aerobic Intradialytic exercise training




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905551


Locations
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Greece
University Hospital of Larissa, Nephrology Clinic
Larissa, Thessaly, Greece, 41110
Patsidis General Clinic
Larissa, Thessaly, Greece
General Hospital of Trikala
Trikala, Thessaly, Greece, 42100
Sponsors and Collaborators
University of Thessaly
National and Kapodistrian University of Athens
Investigators
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Principal Investigator: Giorgos K Sakkas, PhD University of Thessaly
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Giorgos K. Sakkas, Professor in Clinical Exercise Physiology, University of Thessaly
ClinicalTrials.gov Identifier: NCT03905551    
Other Study ID Numbers: 921-5/11/2014
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Giorgos K. Sakkas, University of Thessaly:
cold dialysis
intradialytic exercise
insulin resistance
thermoregulation
muscle architecture
quality of life
fitness
fatigue
physical activity
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic