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

Primary Purpose

End Stage Renal Failure on Dialysis

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Cold Dialysis
Typical Dialysis
Exercise
Sponsored by
University of Thessaly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for End Stage Renal Failure on Dialysis focused on measuring cold dialysis, intradialytic exercise, insulin resistance, thermoregulation, muscle architecture, quality of life, fitness, fatigue, physical activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital of Larissa, Nephrology Clinic
  • Patsidis General Clinic
  • General Hospital of Trikala

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Standard Dialysis

Cold Dialysis

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
Change in Insulin Resistance
Insulin resistances will be assessed by an Oral Glucose Tolerance Test using the OGIS index
Change in Muscle Size
Muscle size will be assessed using Ultrasonography

Secondary Outcome Measures

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
Change in Functional Capacity
Functional capacity will be assessed by the 6 min walking test
Change in Daily Physical activity
Daily physical activity will be assessed by a 7 day recall pedometer

Full Information

First Posted
March 29, 2019
Last Updated
September 28, 2021
Sponsor
University of Thessaly
Collaborators
National and Kapodistrian University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT03905551
Brief Title
Impact of Cold Dialysis in Combination With Intradialytic Exercise in Aspects Related to Quality of Life and Health
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2015 (Actual)
Primary Completion Date
June 29, 2018 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Thessaly
Collaborators
National and Kapodistrian University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Failure on Dialysis
Keywords
cold dialysis, intradialytic exercise, insulin resistance, thermoregulation, muscle architecture, quality of life, fitness, fatigue, physical activity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Dialysis
Arm Type
Placebo Comparator
Arm Description
Patients participated in a 7 months exercise trials receiving standard dialysis (at 37oC)
Arm Title
Cold Dialysis
Arm Type
Experimental
Arm Description
Patients participated in a 7 months exercise trials receiving cold dialysis (at 35oC)
Intervention Type
Procedure
Intervention Name(s)
Cold Dialysis
Intervention Description
Dialysate temperature reduced to 35oC for a period of 7 months.
Intervention Type
Procedure
Intervention Name(s)
Typical Dialysis
Intervention Description
Dialysate temperature is set at 37oC for a period of 7 months
Intervention Type
Procedure
Intervention Name(s)
Exercise
Intervention Description
Aerobic Intradialytic exercise training
Primary Outcome Measure Information:
Title
Change in Body Heat Storage
Description
Body Heat storage will be assessed during the 4 hours of dialysis under the two main conditions. Body Heat Storage is calculated in Watt
Time Frame
Changes from baseline at 7 months
Title
Change in Insulin Resistance
Description
Insulin resistances will be assessed by an Oral Glucose Tolerance Test using the OGIS index
Time Frame
Changes from baseline at 7 months
Title
Change in Muscle Size
Description
Muscle size will be assessed using Ultrasonography
Time Frame
Changes from baseline at 7 months
Secondary Outcome Measure Information:
Title
Change in Quality of life score
Description
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
Time Frame
Changes from baseline at 7 months
Title
Change in Functional Capacity
Description
Functional capacity will be assessed by the 6 min walking test
Time Frame
Changes from baseline at 7 months
Title
Change in Daily Physical activity
Description
Daily physical activity will be assessed by a 7 day recall pedometer
Time Frame
Changes from baseline at 7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giorgos K Sakkas, PhD
Organizational Affiliation
University of Thessaly
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Larissa, Nephrology Clinic
City
Larissa
State/Province
Thessaly
ZIP/Postal Code
41110
Country
Greece
Facility Name
Patsidis General Clinic
City
Larissa
State/Province
Thessaly
Country
Greece
Facility Name
General Hospital of Trikala
City
Trikala
State/Province
Thessaly
ZIP/Postal Code
42100
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
4184202
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. No abstract available.
Results Reference
background
PubMed Identifier
33267815
Citation
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.
Results Reference
background
PubMed Identifier
35018639
Citation
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.
Results Reference
derived
PubMed Identifier
34184202
Citation
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.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/28540201
Description
Cold dialysis and its impact on renal patients' health: An evidence-based mini review.
URL
https://www.ncbi.nlm.nih.gov/pubmed/28682991
Description
The Effect of Cold Dialysis in Motor and Sensory Symptoms of RLS/WED Occurring During Hemodialysis: A Double-Blind Study.

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

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