Sleep and Training Aspects in Dialysis Fatigue - Intervention Receiving Melatonin (StandFirm)
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Purpose
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 6 months intradialytic exercise training (combination of aerobic and resistance training) in combination with melatonin treatment in aspects related to fatigue, quality of life and depression.
| Condition | Intervention | Phase |
|---|---|---|
|
Fatigue |
Drug: Melatonin Other: Exercise Training |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Phase 4 Exercise Training and Melatonin Supplementation in Aspects of Fatigue in Patients Receiving Dialysis Therapy |
- Levels of Fatigue [ Time Frame: 6 months ] [ Designated as safety issue: No ]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: 6 months ] [ Designated as safety issue: No ]Muscle composition will be assessed by MRI. Body Composition will be assessed by DEXA.
- Muscle Functionality [ Time Frame: 6 months ] [ Designated as safety issue: No ]Muscle functionality will be assessed by functional tests. Muscle Fatigue will be assessed by a fatigue protocol.
- Quality of life aspects [ Time Frame: 6 months ] [ Designated as safety issue: No ]Depression, Quality of life will be assessed by questionnaires. Sleep quality and quantity will be assessed by questionnaires and a full night polysomnography.
| Estimated Enrollment: | 80 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Exercise training and Placebo
HD patients will receive a 6 months intradialytic exercise training program in combination with placebo pills.
|
Other: Exercise Training
The patients will be required to complete 3 exercise sessions per week for 24 weeks. Training will include a 35-45 min aerobic training on a rehabilitation cycle ergometer (Monark Rehab Trainer 881E) in the supine position during dialysis session followed by a resistance training session including training in 5 muscle groups (3 sets of 10 reps). The intensity will progress from 30-40% of the maximum exercise power to 60-70%.
Other Name: Cross training (combination of aerobic and resistance)
|
|
Experimental: Exercise and Melatonin
HD patients will receive a 6 months intradialytic exercise training program in combination with 2 mg of Melatonin.
|
Drug: Melatonin
2 mg/day, 2 hours before bed
Other Name: Circadin
Other: Exercise Training
The patients will be required to complete 3 exercise sessions per week for 24 weeks. Training will include a 35-45 min aerobic training on a rehabilitation cycle ergometer (Monark Rehab Trainer 881E) in the supine position during dialysis session followed by a resistance training session including training in 5 muscle groups (3 sets of 10 reps). The intensity will progress from 30-40% of the maximum exercise power to 60-70%.
Other Name: Cross training (combination of aerobic and resistance)
|
|
Experimental: Melatonin
HD patients will receive a 6 months melatonin therapy (2mg/night)
|
Drug: Melatonin
2 mg/day, 2 hours before bed
Other Name: Circadin
|
|
Placebo Comparator: Placebo
HD patients will receive a 6 months Placebo therapy
|
Detailed Description:
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 quality of sleep will increase patients' rest levels resulting in more energy during day and therefore more physical activity, total body and mind recovery and therefore better capacity for exercise, and more secretion of growth hormone and therefore increased anabolism. Our mission is to help the HD patient to better cope with their sensation of fatigue.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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,
Contacts and Locations| Contact: Giorgos K. Sakkas, PhD | 30-2431-500-911 | gsakkas@med.uth.gr |
| Contact: Christina Karatzaferi, PhD | 30-24310-47015 | ck@pe.uth.gr |
| Greece | |
| Patsidis General Clinic | Recruiting |
| Karditsa, Thessaly, Greece | |
| Contact: Spyros Dovas, MD, PhD | |
| Sub-Investigator: Eftixios Patsidis, MD | |
| University Hospital of Larissa | Recruiting |
| Larissa, Thessaly, Greece, 41110 | |
| Contact: Stefania S Grigoriou, MSc 30-2431-500-911 stefaniagrigoriou@gmail.com | |
| Principal Investigator: Ioannis Stefanidis, MD, PhD | |
| General Hospital of Trikala | Recruiting |
| Trikala, Thessaly, Greece, 42100 | |
| Contact: Nikoloaos Tsianas, MD 24313-50122 karatsi@otenet.gr | |
| Sub-Investigator: Nikolaos Tsianas, MD | |
| 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 |
More Information
Publications:
| Responsible Party: | Giorgos K. Sakkas, Research Associate Professor, University of Thessaly |
| ClinicalTrials.gov Identifier: | NCT01721551 History of Changes |
| Other Study ID Numbers: | UTH2-3/10-10-2012 |
| Study First Received: | October 26, 2012 |
| Last Updated: | January 13, 2013 |
| Health Authority: | Greece: National Organization of Medicines |
Keywords provided by University of Thessaly:
|
Dialysis fatigue, exercise intolerance, muscle atrophy, cachexia, disability, |
Sleep disorders Depression Mental Fatigue, Cognitive function Physical Fatigue |
Additional relevant MeSH terms:
|
Fatigue Signs and Symptoms Melatonin Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013