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Completed

NCT Number: NCT01846754

Prevalence of Fatigue in Hemodialysis Patients

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.

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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 1. Unable to complete muscle strength test or questionnaire

Treatment and study plan

Primary outcomes

  1. Relationships Among Fatigue, Muscle Power and Metabolomics

    Time frame: 1-year study

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Prevalence of Fatigue and Its Related Factors in Hemodialysis Patients

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 3, 2013
Registry last updated
Apr 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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