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

End Stage Renal Failure on Dialysis Clinical Trial

— REACD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03905551
• Other study ID #: 921-5/11/2014
• Status: Completed
• Phase: N/A
• Start date: February 1, 2015
• Est. completion date: February 28, 2020

Study information

• Verified date: September 2021
• Source: University of Thessaly
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 28, 2020
• Est. primary completion date: June 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Failure on Dialysis
• Kidney Failure, Chronic

Intervention

Procedure:
• Cold Dialysis
Dialysate temperature reduced to 35oC for a period of 7 months.
• Typical Dialysis
Dialysate temperature is set at 37oC for a period of 7 months
• Exercise
Aerobic Intradialytic exercise training

Locations

Country	Name	City	State
Greece	Patsidis General Clinic	Larissa	Thessaly
Greece	University Hospital of Larissa, Nephrology Clinic	Larissa	Thessaly
Greece	General Hospital of Trikala	Trikala	Thessaly

Sponsors (2)

Lead Sponsor	Collaborator
University of Thessaly	National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change in Muscle Size	Muscle size will be assessed using Ultrasonography	Changes from baseline at 7 months
Secondary	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
Secondary	Change in Functional Capacity	Functional capacity will be assessed by the 6 min walking test	Changes from baseline at 7 months
Secondary	Change in Daily Physical activity	Daily physical activity will be assessed by a 7 day recall pedometer	Changes from baseline at 7 months

External Links

•   Cold dialysis and its impact on renal patients' health: An evidence-based mini review.
•   The Effect of Cold Dialysis in Motor and Sensory Symptoms of RLS/WED Occurring During Hemodialysis: A Double-Blind Study.