- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01721551
Sleep and Training Aspects in Dialysis Fatigue - Exercise Intervention (StandFirm)
Phase 4 Exercise Training in Aspects of Fatigue in Patients Receiving Dialysis Therapy
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Thessaly
-
Larissa, Thessaly, Greece, 41110
- University Hospital of Larissa
-
Larissa, Thessaly, Greece
- Patsidis General Clinic
-
Trikala, Thessaly, Greece, 42100
- General Hospital of Trikala
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise training
HD patients will receive a 9 months intradialytic exercise training program
|
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%.
|
Placebo Comparator: No exercise
HD patients will not participate in any type of systematic exercise training
|
The CON group received no intervention but the usual treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Levels of Fatigue
Time Frame: 9 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body composition
Time Frame: 9 months
|
Muscle composition will be assessed by BCM bio impedance system
|
9 months
|
Muscle Functionality
Time Frame: 9 months
|
Muscle functionality will be assessed by functional tests.
Muscle Fatigue will be assessed by a fatigue protocol.
|
9 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life aspects
Time Frame: 9 months
|
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
|
Cardiac functionality
Time Frame: 9 months
|
Structural and functional characteristics of the heart will be assessed by an ecocardiography system before, during and after hemodialysis
|
9 months
|
Neurological Assessment
Time Frame: 9 months
|
Full neurological assessment will take place
|
9 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christina Karatzaferi, PhD, University of Thessaly
- Principal Investigator: Giorgos K. Sakkas, PhD, Center for Research and Technology Thessaly - University of Thessaly
- Study Director: Ioannis Stefanidis, MD, PhD, University of Thessaly
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UTH2-3/10-10-2012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fatigue
-
Bakulev Scientific Center of Cardiovascular SurgeryFoundation for the Support of Physical Culture and Sports BECOME A CHAMPION; Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPIONNot yet recruitingEfficacy, Self | Fatigue, Mental | Fatigue; Muscle, Heart | Fatigue; CombatRussian Federation
-
Universita di VeronaUniversity of Southern CaliforniaCompletedDiet, Healthy | Fasting | Fatigue, Mental | Fatigue; Muscle, HeartItaly
-
Supplement Formulators, Inc.Completed
-
University of ZurichRecruitingVocal FatigueSwitzerland
-
KU LeuvenCompleted
-
Société des Produits Nestlé (SPN)Maastricht University Medical CenterCompleted
-
University of Applied Sciences for Health Professions...University of Wisconsin, MilwaukeeCompleted
-
Taoyuan General HospitalCompleted
-
Alaa Yousri Mahmoud AtiaUnknownMuscle FatigueEgypt
-
University Hospital, Clermont-FerrandLaboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques...CompletedNeuromuscular FatigueFrance
Clinical Trials on Exercise
-
University of Kansas Medical CenterRecruiting
-
National Institute of Neurological Disorders and...TerminatedTraumatic Brain InjuryUnited States
-
University of Alabama at BirminghamCompletedCystic FibrosisUnited States
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
University of Texas, El PasoRecruitingKnee Osteoarthritis | Knee Pain Chronic | Central Pain SyndromeUnited States
-
University of Missouri-ColumbiaCompleted
-
University of AlcalaCompletedMyofascial Pain | Myofascial Pain Syndrome | Post Needling Soreness | Myofascial Trigger Point PainSpain
-
Sahmyook UniversityRecruitingChronic Nonspecific Neck PainKorea, Republic of
-
University of AlbertaWomen and Children's Health Research Institute, CanadaRecruitingType 1 Diabetes | Post-menopauseCanada
-
Uskudar UniversityCompleted