Sleep and Training Aspects in Dialysis Fatigue - Exercise Intervention (StandFirm)
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|ClinicalTrials.gov Identifier: NCT01721551|
Recruitment Status : Completed
First Posted : November 5, 2012
Last Update Posted : June 22, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Fatigue||Other: Exercise||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Factorial Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Phase 4 Exercise Training in Aspects of Fatigue in Patients Receiving Dialysis Therapy|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Experimental: Exercise training
HD patients will receive a 9 months intradialytic exercise training program
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%.
Placebo Comparator: No exercise
HD patients will not participate in any type of systematic exercise training
- Levels of Fatigue [ Time Frame: 9 months ]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.
- Body composition [ Time Frame: 9 months ]Muscle composition will be assessed by BCM bio impedance system
- Muscle Functionality [ Time Frame: 9 months ]Muscle functionality will be assessed by functional tests. Muscle Fatigue will be assessed by a fatigue protocol.
- Quality of life aspects [ Time Frame: 9 months ]Depression, Quality of life will be assessed by questionnaires. Sleep quality and quantity will be assessed by questionnaires and a full night polysomnography.
- Cardiac functionality [ Time Frame: 9 months ]Structural and functional characteristics of the heart will be assessed by an ecocardiography system before, during and after hemodialysis
- Neurological Assessment [ Time Frame: 9 months ]Full neurological assessment will take place
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721551
|Patsidis General Clinic|
|Karditsa, Thessaly, Greece|
|University Hospital of Larissa|
|Larissa, Thessaly, Greece, 41110|
|General Hospital of Trikala|
|Trikala, Thessaly, Greece, 42100|
|Principal Investigator:||Giorgos K. Sakkas, PhD||Center for Research and Technology Thessaly - University of Thessaly|
|Principal Investigator:||Christina Karatzaferi, PhD||University of Thessaly|
|Study Director:||Ioannis Stefanidis, MD, PhD||University of Thessaly|