Prevalence of Fatigue in Hemodialysis Patients

Hemodialysis Patients Clinical Trial

Official title:

Prevalence of Fatigue and Its Related Factors in Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01846754
• Other study ID #: 201302037RINC
• Status: Completed
• Phase: N/A
• First received: May 1, 2013
• Last updated: April 17, 2014
• Start date: June 2013
• Est. completion date: July 2013

Study information

• Verified date: April 2014
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

The prevalence of end stage renal disease in Taiwan was listed first all over the world. Fatigue, which makes patients unable to be competitive to play their functional roles, is one of the most bothersome symptoms of patients receiving long-term hemodialysis. Tracing back to the development of its relating studies, there is no accurate reason that why does people undergoing hemodialysis feel fatigued. Conclusive predictors of fatigue are still not shown up yet. Paper review indicated that the level of L-Carnitine concentration, which affect metabolism of fatty acid, had correlation with fatigue and muscle strength in this population. The serum concentration of L-Carnitine is influenced a lot by hemodialysis. When there is deficiency of energy supply, it resulted to decline of muscle strength, which increased frequency and intensity of fatigue. Hence, the purposes of this study are (1) to understand the basic condition of fatigue level, muscle and metabolism of fat and carbohydrate among hemodialysis patients, (2) to analyze correlation among muscle strength, metabolism of fat/carbohydrate, and fatigue, and (3) to understand correlations among demographic characteristics, blood test data (hemoglobin, albumin, Kt/V, urea reduction ratio(URR), blood urea nitrogen(BUN), creatinine, calcium, phosphorus, and C-reactive protein), mental and social conditions (depression, anxiety, and social support), muscle strength and fatigue, seeking further exploring predictors of muscle strength and fatigue.

The study use cross-sectional descriptive correlative design with consecutive sampling. Recruit patients from a hemodialysis unit in a medical center in north Taiwan after informed- consent. The estimated sample size is 100. To understand relationship among muscle strength, by-products of fatty acid and carbohydrate and fatigue, we collect data by measuring their muscle strength (handgrip and 30 seconds sit-to-stand), and analyzing blood test data and the structured questionnaires which included mental/social data (depression, anxiety, social support and fatigue level). Descriptive statistics, ANOVA, Pearson's correlation, Spearsman's rank correlation and stepwise regression were used to analyze the collected data. Hope this research can get advance in comprehension of cause of fatigue and improve the fatigue symptom of hemodialysis patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• 1.Hemodialysis Patients 2.Aged above 20 3.Consciousness: oriented

Exclusion Criteria:

• 1. Unable to complete muscle strength test or questionnaire

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemodialysis Patients

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationships Among Fatigue, Muscle Power and Metabolomics		1-year study	No