Sleep and Training Aspects in Dialysis Fatigue - Exercise Intervention

NCT01721551 | Completed DMC

• 1 other identifier: UTH2-3/10-10-2012
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Fatigue

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Levels of Fatigue

  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 Outcomes (2)

• Body composition

  9 months

• Muscle Functionality

  9 months

Other Outcomes (3)

• Quality of life aspects

  9 months

• Cardiac functionality

  9 months

• Neurological Assessment

  9 months

Study Arms (2)

Exercise training

EXPERIMENTAL

HD patients will receive a 9 months intradialytic exercise training program

Other: Exercise

No exercise

PLACEBO COMPARATOR

HD patients will not participate in any type of systematic exercise training

Other: Usual Treatment

Interventions

Exercise OTHER

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%.

Exercise training

Usual Treatment OTHER

The CON group received no intervention but the usual treatment

No exercise

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• University of Thessaly: lead
• Greek Ministry of Development: collaborator
• Larissa University Hospital: collaborator

Study Sites (3)

University Hospital of Larissa

Larissa, Thessaly, 41110, Greece

Location

Patsidis General Clinic

Larissa, Thessaly, Greece

Location

General Hospital of Trikala

Trikala, Thessaly, 42100, Greece

Location

Related Publications (6)

• 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.

  PMID: 22934057 BACKGROUND

• 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.

  PMID: 34100215 BACKGROUND

• 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.

  PMID: 33387217 BACKGROUND

• 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.

  PMID: 26973957 BACKGROUND

• Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.

  PMID: 37651553 DERIVED

• 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.

  PMID: 35018639 DERIVED

MeSH Terms

Conditions

Fatigue; Muscular Atrophy; Cachexia; Sleep Wake Disorders; Depression; Mental Fatigue

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Weight Loss; Body Weight Changes; Body Weight; Thinness; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Giorgos K. Sakkas, PhD

  Center for Research and Technology Thessaly - University of Thessaly

  PRINCIPAL INVESTIGATOR

• Christina Karatzaferi, PhD

  University of Thessaly

  PRINCIPAL INVESTIGATOR

• Ioannis Stefanidis, MD, PhD

  University of Thessaly

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: October 26, 2012
• First Posted: November 5, 2012
• Study Start: November 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (3)