Sleep and Training Aspects in Dialysis Fatigue - Exercise Intervention

Study Overview
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Brief Summary
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The purpose of the current study is to investigate whether changes in patients' sleep quality and quantity will be followed by improvements in parameters related to physical and mental fatigue in patients receiving hemodialysis therapy. More specific, the current project will investigate the effect of a 9 months intradialytic exercise training in aspects related to fatigue, quality of life and depression.

Detailed Description
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Chronic renal disease is a silent epidemic affecting up to 10% of the population in the EU, USA, and Asian with some of the sufferers progressing into end-stage renal failure. Renal disease patients are characterized by progressively worsening muscle weakness and muscle atrophy due to both a metabolic and a disuse component collectively described as uremic myopathy. While various interventions in stable HD patients have helped these patients improve their functionality, they still have not proven enough to bring their muscle quality and quantity up to the levels of a healthy sedentary person. Moreover, patients present with sleep problems, neurological and quality of life issues, anxiety and/or symptoms of depression but most notably they complain of chronic fatigue and lack of energy. Other factors that contribute to the excessive fatigue are a lack of restorative sleep, excess pre-dialysis weight, poor nutritional status, restless legs syndrome and the overall mental status of the patients. Evidently, of all of these factors can contribute to a self-exacerbating process, a vicious circle, of fatigue due to inactivity and further inactivity due to fatigue. This sensation of an enduring fatigue interferes with physical and social activities and feeds perceptions of increased restrictions and barriers, and leads to a significant reduction of physical activity and functional capacity, which in turn contributes to the increased cardiovascular risk and a high mortality rate among these patients. Rationale: The investigators hypothesize that by improving the patients fitness levels, it will lead in more energy during day and therefore less fatigue. Our mission is to help the HD patient to better cope with their sensation of fatigue.

Official Title
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Phase 4 Exercise Training in Aspects of Fatigue in Patients Receiving Dialysis Therapy

Conditions
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Fatigue

Intervention / Treatment
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* Other: Exercise
* Other: Usual Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult hemodialysis patients both sexes who has received regular HD treatment for at least 6 months, adequate dialysis delivery with Kt/V >1.1 and good compliance with dialysis treatment, with serum albumin > 2.5 g/dL, hemoglobin>= 11g/dL sleep onset latency > 15 minutes or sleep efficiency < 85% or arousal index > 25 Exclusion Criteria: Patients unable to give informed consent, with opportunistic infection in the last 3 months, malignancy or infection requiring intravenous antibiotics within 2 months prior to enrollment, myoskeletal contraindication to exercise requirement for systemic anticoagulation, participating or participated in an investigational drug or medical device study within 30 days or five half-lives, pregnant, breast feed or female of childbearing potential who does not agree to remain abstinent or to use an acceptable contraceptive regimen, lactate dehydrogenase > 300U/L, prolonged heart wave (QT) interval (as defined by corrected QT (QTc) > 460 msec in males and > 470 msec in females) on screening electrocardiogram (ECG), known current alcohol or drug abuse, known or suspected hypersensitivity to the study medication or any of its ingredients,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise training<br>HD patients will receive a 9 months intradialytic exercise training program | Other: Exercise<br>* Training will include a 45-60 min aerobic training on a rehabilitation cycle ergometer (Monark Rehab Trainer 881E) in the supine position during dialysis session. The intensity will progress from 30-40% of the maximum exercise power to 60-70%.<br>|
| Placebo Comparator: No exercise<br>HD patients will not participate in any type of systematic exercise training | Other: Usual Treatment<br>* The CON group received no intervention but the usual treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of Fatigue | Fatigue will be assessed by direct and indirect measurements. Physical Fatigue will be assessed by hand grip, functional tests, cardiorespiratory max test. Mental Fatigue will be assessed by questionnaires. Cognitive Fatigue will be assessed by questionnaires. Pre and Post dialysis fatigue will be assessed by hand grip and questionnaires. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Muscle composition will be assessed by BCM bio impedance system | 9 months | 
| Muscle Functionality | Muscle functionality will be assessed by functional tests. Muscle Fatigue will be assessed by a fatigue protocol. | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis fatigue,, exercise intolerance,, muscle atrophy,, cachexia,, disability,, Sleep disorders, Depression, Mental Fatigue,, Cognitive function, Physical Fatigue