Sleep and Training Aspects in Dialysis Fatigue - Exercise Intervention (StandFirm)

October 6, 2021 updated by: Giorgos K. Sakkas, University of Thessaly

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

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

October 26, 2012

First Submitted That Met QC Criteria

November 2, 2012

First Posted (Estimate)

November 4, 2012

Study Record Updates

Last Update Posted (Actual)

October 14, 2021

Last Update Submitted That Met QC Criteria

October 6, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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