Sleep and Training Aspects in Dialysis Fatigue - Exercise Intervention

Fatigue Clinical Trial

— StandFirm  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721551
• Other study ID #: UTH2-3/10-10-2012
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: June 2015

Study information

• Verified date: October 2021
• Source: University of Thessaly
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 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.

Recruitment information / eligibility

• 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,

Related Conditions & MeSH terms

• Fatigue

Intervention

Other:
• Exercise
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%.
• Usual Treatment
The CON group received no intervention but the usual treatment

Locations

Country	Name	City	State
Greece	Patsidis General Clinic	Larissa	Thessaly
Greece	University Hospital of Larissa	Larissa	Thessaly
Greece	General Hospital of Trikala	Trikala	Thessaly

Sponsors (3)

Lead Sponsor	Collaborator
University of Thessaly	Greek Ministry of Development, Larissa University Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (4)

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

Outcome

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