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Sleep and Training Aspects in Dialysis Fatigue - Exercise Intervention

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01721551
Acronym
StandFirm
Enrollment
50
Registered
2012-11-05
Start date
2012-11-30
Completion date
2015-06-30
Last updated
2021-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue

Keywords

Dialysis fatigue,, exercise intolerance,, muscle atrophy,, cachexia,, disability,, Sleep disorders, Depression, Mental Fatigue,, Cognitive function, Physical Fatigue

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.

Interventions

OTHERExercise

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%.

OTHERUsual Treatment

The CON group received no intervention but the usual treatment

Sponsors

Greek Ministry of Development
CollaboratorOTHER_GOV
Larissa University Hospital
CollaboratorOTHER
University of Thessaly
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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,

Design outcomes

Primary

MeasureTime frameDescription
Levels of Fatigue9 monthsFatigue 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.

Secondary

MeasureTime frameDescription
Body composition9 monthsMuscle composition will be assessed by BCM bio impedance system
Muscle Functionality9 monthsMuscle functionality will be assessed by functional tests. Muscle Fatigue will be assessed by a fatigue protocol.

Other

MeasureTime frameDescription
Quality of life aspects9 monthsDepression, Quality of life will be assessed by questionnaires. Sleep quality and quantity will be assessed by questionnaires and a full night polysomnography.
Cardiac functionality9 monthsStructural and functional characteristics of the heart will be assessed by an ecocardiography system before, during and after hemodialysis
Neurological Assessment9 monthsFull neurological assessment will take place

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026