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

This study has been completed.
Sponsor:
Collaborators:
Greek Ministry of Development
Larissa University Hospital
Information provided by (Responsible Party):
Giorgos K. Sakkas, University of Thessaly
ClinicalTrials.gov Identifier:
NCT01721551
First received: October 26, 2012
Last updated: June 19, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention Phase
Fatigue
Other: Exercise
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Phase 4 Exercise Training in Aspects of Fatigue in Patients Receiving Dialysis Therapy

Resource links provided by NLM:


Further study details as provided by University of Thessaly:

Primary Outcome Measures:
  • Levels of Fatigue [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Body composition [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Muscle composition will be assessed by BCM bio impedance system

  • Muscle Functionality [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Muscle functionality will be assessed by functional tests. Muscle Fatigue will be assessed by a fatigue protocol.


Other Outcome Measures:
  • Quality of life aspects [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Depression, Quality of life will be assessed by questionnaires. Sleep quality and quantity will be assessed by questionnaires and a full night polysomnography.

  • Cardiac functionality [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Structural and functional characteristics of the heart will be assessed by an ecocardiography system before, during and after hemodialysis

  • Neurological Assessment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Full neurological assessment will take place


Enrollment: 50
Study Start Date: November 2012
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise training
HD patients will receive a 9 months intradialytic exercise training program
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%.
Placebo Comparator: No exercise
HD patients will not participate in any type of systematic exercise training

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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,

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721551

Locations
Greece
Patsidis General Clinic
Karditsa, Thessaly, Greece
University Hospital of Larissa
Larissa, Thessaly, Greece, 41110
General Hospital of Trikala
Trikala, Thessaly, Greece, 42100
Sponsors and Collaborators
University of Thessaly
Greek Ministry of Development
Larissa University Hospital
Investigators
Principal Investigator: Giorgos K. Sakkas, PhD Center for Research and Technology Thessaly - University of Thessaly
Principal Investigator: Christina Karatzaferi, PhD University of Thessaly
Study Director: Ioannis Stefanidis, MD, PhD University of Thessaly
  More Information

Publications:
Responsible Party: Giorgos K. Sakkas, Research Associate Professor, University of Thessaly
ClinicalTrials.gov Identifier: NCT01721551     History of Changes
Other Study ID Numbers: UTH2-3/10-10-2012
Study First Received: October 26, 2012
Last Updated: June 19, 2015
Health Authority: Greece: National Organization of Medicines

Keywords provided by University of Thessaly:
Dialysis fatigue,
exercise intolerance,
muscle atrophy,
cachexia,
disability,
Sleep disorders
Depression
Mental Fatigue,
Cognitive function
Physical Fatigue

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on July 01, 2015