StandFirm: Sleep and Training Aspects in Dialysis Fatigue - Exercise Intervention

Sponsor

University of Thessaly (Other)

Overall Status

Completed

CT.gov ID

NCT01721551

Collaborator

Greek Ministry of Development (Other), Larissa University Hospital (Other)

Enrollment

Locations

Arms

30.9

Duration (Months)

16.7

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fatigue	Other: Exercise Other: Usual Treatment	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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	Other: Usual Treatment The CON group received no intervention but the usual treatment

Arm

Intervention/Treatment

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

Other: Usual Treatment

The CON group received no intervention but the usual treatment

Outcome Measures

Primary Outcome Measures

Levels of Fatigue [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.

Secondary Outcome Measures

Body composition [9 months]
Muscle composition will be assessed by BCM bio impedance system
Muscle Functionality [9 months]
Muscle functionality will be assessed by functional tests. Muscle Fatigue will be assessed by a fatigue protocol.

Other Outcome Measures

Quality of life aspects [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.
Cardiac functionality [9 months]
Structural and functional characteristics of the heart will be assessed by an ecocardiography system before, during and after hemodialysis
Neurological Assessment [9 months]
Full neurological assessment will take place

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Larissa	Larissa	Thessaly	Greece	41110
2	Patsidis General Clinic	Larissa	Thessaly	Greece
3	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