Impact of Cold Dialysis in Combination With Intradialytic Exercise in Aspects Related to Quality of Life and Health (REACD)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Thessaly
-
Larissa, Thessaly, Greece, 41110
- University Hospital of Larissa, Nephrology Clinic
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Larissa, Thessaly, Greece
- Patsidis General Clinic
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Trikala, Thessaly, Greece, 42100
- General Hospital of Trikala
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
PLACEBO_COMPARATOR: Standard Dialysis
Patients participated in a 7 months exercise trials receiving standard dialysis (at 37oC)
|
Dialysate temperature is set at 37oC for a period of 7 months
Aerobic Intradialytic exercise training
|
|
EXPERIMENTAL: Cold Dialysis
Patients participated in a 7 months exercise trials receiving cold dialysis (at 35oC)
|
Aerobic Intradialytic exercise training
Dialysate temperature reduced to 35oC for a period of 7 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Changes from baseline at 7 months
|
|
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
|
Changes from baseline at 7 months
|
|
Change in Muscle Size
Time Frame: Changes from baseline at 7 months
|
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
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:
|
Changes from baseline at 7 months
|
|
Change in Functional Capacity
Time Frame: Changes from baseline at 7 months
|
Functional capacity will be assessed by the 6 min walking test
|
Changes from baseline at 7 months
|
|
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
|
Changes from baseline at 7 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
- Parnas I, Spira M, Werman R, Bergmann F. Micro-electrode studies of the giant fibres of the American cockroach. Electroencephalogr Clin Neurophysiol. 1969 Aug;27(2):221. No abstract available.
- Krase AA, Flouris AD, Karatzaferi C, Giannaki CD, Stefanidis I, Sakkas GK. Separate and combined effects of cold dialysis and intradialytic exercise on the thermoregulatory responses of hemodialysis patients: a randomized-cross-over study. BMC Nephrol. 2020 Dec 2;21(1):524. doi: 10.1186/s12882-020-02167-z.
- Krase AA, Terzis G, Giannaki CD, Stasinaki AN, Wilkinson TJ, Smith AC, Zorz C, Karatzaferi C, Stefanidis I, Sakkas GK. Seven months of aerobic intradialytic exercise training can prevent muscle loss in haemodialysis patients: an ultrasonography study. Int Urol Nephrol. 2022 Feb;54(2):447-456. doi: 10.1007/s11255-021-02931-6. Epub 2021 Jun 28.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 921-5/11/2014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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