Clinical trial NCT01721551: Sleep and Training Aspects in Dialysis Fatigue - Exercise Intervention
Official title: Phase 4 Exercise Training in Aspects of Fatigue in Patients Receiving Dialysis Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Keywords: Dialysis fatigue,
exercise intolerance,
muscle atrophy,
cachexia,
disability,
Sleep disorders
Depression
Mental Fatigue,
Cognitive function
Physical Fatigue
Lead sponsor: University of Thessaly
Sponsor class: OTHER
Collaborators: name: Greek Ministry of Development
name: Larissa University Hospital
First posted: 2012-11-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 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.

Eligibility criteria: 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,

Primary outcomes:
measure: Levels of Fatigue
timeFrame: 9 months
Secondary outcomes:
measure: Body composition
timeFrame: 9 months
measure: Muscle Functionality
timeFrame: 9 months
Other outcomes:
measure: Quality of life aspects
timeFrame: 9 months
measure: Cardiac functionality
timeFrame: 9 months
measure: Neurological Assessment
timeFrame: 9 months
Locations:
city: Larissa
country: Greece
facility: University Hospital of Larissa
state: Thessaly
city: Larissa
country: Greece
facility: Patsidis General Clinic
state: Thessaly
city: Trikala
country: Greece
facility: General Hospital of Trikala
state: Thessaly
Study officials:
affiliation: Center for Research and Technology Thessaly - University of Thessaly
name: Giorgos K. Sakkas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Thessaly
name: Christina Karatzaferi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Thessaly
name: Ioannis Stefanidis, MD, PhD
role: STUDY_DIRECTOR
References:
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. No abstract available.
citation: 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-naive dialysis patients: a randomized, cross-over trial. Int Urol Nephrol. 2022 Jan;54(1):201-208. doi: 10.1007/s11255-021-02910-x. Epub 2021 Jun 7.
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.
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.
citation: Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.