The Study in the Correlation Between the Severity of Post-stroke Fatigue and the Severity of qi Deficiency and Blood Stasis

The Study in the Correlation Between the Severity of Post-stroke Fatigue and the Severity of qi Deficiency and Blood Stasis in Chinese Medicine.

The purpose of the present study was to investigate the correlation between the severity of fatigue, and the severity of qi deficiency and blood stasis.

Study Overview

• Status: Unknown
• Conditions: Poststroke Fatigue

Detailed Description

According to the reports of department of Health, stroke has been the top three ranking in leading ten major mortality causes. Although fatigue is a common symptom after stroke, but it is easy to neglect due to fatigue is a non-specific symptom. Based on the literature review, fatigue symptom is not only common on post-stroke patient and it also has highly correlation with mortality, prognosis and efficacy of rehabilitation. In Traditional Chinese Medicine recording, Wang Qing-ren suggests that the main etiology of stroke is results from qi stagnation and blood stasis, thereafter, the study about qi deficiency and blood stasis became to the main stream for stroke until now. Therefore, the purpose of the present study was to investigate the correlation between the severity of fatigue, and the severity of qi deficiency and blood stasis.

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 40447
    • Recruiting
    • China Medical University Hospital
    • Contact: Ching-Liang Hsieh, professor; Phone Number: 3600 886-4-22053366; Email: clhsieh@mail.cmuh.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with post-stroke fatigue were enrolled from the departments of neurological, neurosurgical, and rehabilitation in China Medical University Hospital (Taichung, Taiwan), their Brief Fatigue Inventory-Taiwan form score ≥ 4, and stroke onset more than 3 months.

Description

Inclusion Criteria:

1. Gender: men or women
2. Age:40~80 years old
3. Stroke history at least 3 months
4. Hemorrhage or ischemic stoke
5. Conscious clear and can communicate
6. Brief Fatigue Inventory-Taiwan form score ≥ 4
7. Sign informed consent

Exclusion Criteria:

1. Patient with psychotic diagnosis and can't cooperate with researcher
2. Major disease: chronic obstructive pulmonary disease, heart failure, myocardial infarction, chronic renal failure, liver cirrhosis
3. Pregnant women
4. Breastfeeding women

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
fatigue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frome Fatigue severity level scale to evaluate fatigue severity score.	When patient visit first time,we complete all the evaluation scale. Total evaluation time is about 20 minutes. And all data will be analyzed one year later.	about 20 minutes

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ANTICIPATED): June 1, 2013
• Study Completion (ANTICIPATED): June 1, 2013

Study Registration Dates

• First Submitted: August 14, 2012
• First Submitted That Met QC Criteria: August 20, 2012
• First Posted (ESTIMATE): August 21, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 21, 2012
• Last Update Submitted That Met QC Criteria: August 20, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: DMR101-IRB2-151