Prevalence of Fatigue in Hemodialysis Patients

NCT ID: NCT01846754

Last Updated: 2014-04-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 88 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2013-07-31

Brief 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.

Conditions

Hemodialysis Patients

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Hemodialysis patients

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 1. Unable to complete muscle strength test or questionnaire

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shiow-Ching Shun Shun, PHD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

201302037RINC

Identifier Type: -

Identifier Source: org_study_id