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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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18 October 2021 |
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Main ID: |
NCT01721551 |
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Date of registration:
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26/10/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Sleep and Training Aspects in Dialysis Fatigue - Exercise Intervention
StandFirm |
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Scientific title:
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Phase 4 Exercise Training in Aspects of Fatigue in Patients Receiving Dialysis Therapy |
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Date of first enrolment:
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November 2012 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01721551 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Supportive Care. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Greece
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Contacts
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Name:
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Ioannis Stefanidis, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Thessaly |
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Name:
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Christina Karatzaferi, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Thessaly |
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Name:
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Giorgos K. Sakkas, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Center for Research and Technology Thessaly - University of Thessaly |
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Key inclusion & exclusion 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,
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Fatigue
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Intervention(s)
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Other: Usual Treatment
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Other: Exercise
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Primary Outcome(s)
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Levels of Fatigue
[Time Frame: 9 months]
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Secondary Outcome(s)
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Body composition
[Time Frame: 9 months]
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Muscle Functionality
[Time Frame: 9 months]
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Secondary ID(s)
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UTH2-3/10-10-2012
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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