Clinical trial NCT03905551: Impact of Cold Dialysis in Combination With Intradialytic Exercise in Aspects Related to Quality of Life and Health
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
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Failure on Dialysis
Keywords: cold dialysis
intradialytic exercise
insulin resistance
thermoregulation
muscle architecture
quality of life
fitness
fatigue
physical activity
Lead sponsor: University of Thessaly
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
First posted: 2019-04-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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:

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.

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.

Primary outcomes:
measure: Change in Body Heat Storage
timeFrame: Changes from baseline at 7 months
measure: Change in Insulin Resistance
timeFrame: Changes from baseline at 7 months
measure: Change in Muscle Size
timeFrame: Changes from baseline at 7 months
Secondary outcomes:
measure: Change in Quality of life score
timeFrame: Changes from baseline at 7 months
measure: Change in Functional Capacity
timeFrame: Changes from baseline at 7 months
measure: Change in Daily Physical activity
timeFrame: Changes from baseline at 7 months
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University Hospital of Larissa, Nephrology Clinic
state: Thessaly
city: Larissa
country: Greece
facility: Patsidis General Clinic
state: Thessaly
city: Trikala
country: Greece
facility: General Hospital of Trikala
state: Thessaly
Study officials:
affiliation: University of Thessaly
name: Giorgos K Sakkas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.