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

NCT03905551 | Completed

• 1 other identifier: 921-5/11/2014
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

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.

Conditions

End Stage Renal Failure on Dialysis

Keywords

cold dialysis; intradialytic exercise; insulin resistance; thermoregulation; muscle architecture; quality of life; fitness; fatigue; physical activity

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Change in Muscle Size

  Muscle size will be assessed using Ultrasonography

  Changes from baseline at 7 months

Secondary Outcomes (3)

• Change in Quality of life score

  Changes from baseline at 7 months

• Change in Functional Capacity

  Changes from baseline at 7 months

• Change in Daily Physical activity

  Changes from baseline at 7 months

Study Arms (2)

Standard Dialysis

PLACEBO COMPARATOR

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

Procedure: Typical Dialysis; Procedure: Exercise

Cold Dialysis

EXPERIMENTAL

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

Procedure: Cold Dialysis; Procedure: Exercise

Interventions

Cold Dialysis PROCEDURE

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

Cold Dialysis

Typical Dialysis PROCEDURE

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

Standard Dialysis

Exercise PROCEDURE

Aerobic Intradialytic exercise training

Cold Dialysis; Standard Dialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Thessaly: lead
• National and Kapodistrian University of Athens: collaborator

Study Sites (3)

University Hospital of Larissa, Nephrology Clinic

Larissa, Thessaly, 41110, Greece

Location

Patsidis General Clinic

Larissa, Thessaly, Greece

Location

General Hospital of Trikala

Trikala, Thessaly, 42100, Greece

Location

Related Publications (5)

• 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.

  PMID: 4184202 BACKGROUND

• 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.

  PMID: 33267815 BACKGROUND

• Krase AA, Giannaki CD, Flouris AD, Liakos D, Stefanidis I, Karatzaferi C, Sakkas GK. The Acute, Combined, and Separate Effects of Cold Hemodialysis and Intradialytic Exercise in Insulin Sensitivity and Glucose Disposal. ASAIO J. 2024 May 1;70(5):436-441. doi: 10.1097/MAT.0000000000002117. Epub 2024 Jan 23.

  PMID: 38261536 DERIVED

• 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.

  PMID: 35018639 DERIVED

• 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.

  PMID: 34184202 DERIVED

Related 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.

MeSH Terms

Conditions

Insulin Resistance; Fatigue; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Giorgos K Sakkas, PhD

  University of Thessaly

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Clinical Exercise Physiology

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 5, 2019
• Study Start: February 1, 2015
• Primary Completion: June 29, 2018
• Study Completion: February 28, 2020
• Last Updated: October 6, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (3)