Fatigue Clinical Trial
— StandFirmOfficial title:
Phase 4 Exercise Training in Aspects of Fatigue in Patients Receiving Dialysis Therapy
Verified date | October 2021 |
Source | University of Thessaly |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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, |
Country | Name | City | State |
---|---|---|---|
Greece | Patsidis General Clinic | Larissa | Thessaly |
Greece | University Hospital of Larissa | Larissa | Thessaly |
Greece | General Hospital of Trikala | Trikala | Thessaly |
Lead Sponsor | Collaborator |
---|---|
University of Thessaly | Greek Ministry of Development, Larissa University Hospital |
Greece,
Grigoriou SS, Giannaki CD, George K, Karatzaferi C, Zigoulis P, Eleftheriadis T, Stefanidis I, Sakkas GK. A single bout of hybrid intradialytic exercise did not affect left-ventricular function in exercise-naïve dialysis patients: a randomized, cross-over trial. Int Urol Nephrol. 2021 Jun 7. doi: 10.1007/s11255-021-02910-x. [Epub ahead of print] — View Citation
Grigoriou SS, Karatzaferi C, Sakkas GK. Pharmacological and Non-pharmacological Treatment Options for Depression and Depressive Symptoms in Hemodialysis Patients. Health Psychol Res. 2015 Apr 13;3(1):1811. doi: 10.4081/hpr.2015.1811. eCollection 2015 Apr 13. Review. — View Citation
Grigoriou SS, Krase AA, Karatzaferi C, Giannaki CD, Lavdas E, Mitrou GI, Bloxham S, Stefanidis I, Sakkas GK. Long-term intradialytic hybrid exercise training on fatigue symptoms in patients receiving hemodialysis therapy. Int Urol Nephrol. 2021 Apr;53(4):771-784. doi: 10.1007/s11255-020-02711-8. Epub 2021 Jan 2. — View Citation
Sakkas GK, Karatzaferi C. Hemodialysis fatigue: just "simple" fatigue or a syndrome on its own right? Front Physiol. 2012 Jul 31;3:306. doi: 10.3389/fphys.2012.00306. eCollection 2012. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Quality of life aspects | Depression, Quality of life will be assessed by questionnaires. Sleep quality and quantity will be assessed by questionnaires and a full night polysomnography. | 9 months | |
Other | Cardiac functionality | Structural and functional characteristics of the heart will be assessed by an ecocardiography system before, during and after hemodialysis | 9 months | |
Other | Neurological Assessment | Full neurological assessment will take place | 9 months | |
Primary | 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 | Body composition | Muscle composition will be assessed by BCM bio impedance system | 9 months | |
Secondary | Muscle Functionality | Muscle functionality will be assessed by functional tests. Muscle Fatigue will be assessed by a fatigue protocol. | 9 months |
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