Change of Fatigue and Physical Fitness in Hospitalized Hematology Patients

Acute Leukemia Clinical Trial

Official title:

Change of Fatigue and Physical Fitness and Their Related Factors in Hospitalized Hematology Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01603290
• Other study ID #: 201111066RIC
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 18, 2012
• Last updated: May 18, 2012
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: May 2012
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purposes of this study are to (1) explore the severity of symptom of leukemia patients experienced before and after chemotherapy in hospital, (2) investigate the trajectories of the fatigue and physical fitness, and their related factors, and (3) the correlation between fatigue and physical fitness

Description:

Cancer-Related Fatigue (CRF) is one of the common distressed symptoms that leukemia patients experienced during the period of chemotherapy. Exercise is the most effective non-pharmacologic treatment but inpatients refuse to do exercise in clinical settings in Taiwan. Decreased physical activity may increase the intensity of fatigue and degenerate the physical fitness; however, there is no study to explore the trajectories of fatigue and physical fitness for leukemia patient during hospitalization. Therefore, the purposes of this study are to (1) explore the severity of symptom of leukemia patients experienced before and after chemotherapy in hospital, (2) investigate the trajectories of the fatigue and physical fitness, and their related factors, and (3) the correlation between fatigue and physical fitness. A longitudinal designed study will be conducted to recruit the leukemia patients in a medical center in Taipei. Eligible patients are those will be going to receive chemotherapy and in hospital at least one week. Time periods for data collection will be in the first 48 hours after hospitalization (T0) and the 48 hours before the patient discharged (T1). A set of structured questionnaire will be used to collected data including the Background information form, the Fatigue Symptom Inventory, the Cancer Fatigue Scale, the Symptom Severity Scale, and the Hospital Anxiety and Depression Scale. Patients will be received physical fitness test including the 6-Minute Walking Test, grip strength, and 30-second chair stand test. The descriptive statistics will be used to analyze the severity of symptom distress, fatigue, and the change of physical fitness, and the inferential statistics was used to analyze the correlation of the symptom, fatigue, and physical fitness. Besides, generalized estimating equations (GEE) will be used to analysis the average of population change of fatigue and physical fitness.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 130
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Acute leukemia patients with first complete remission status

• Aged above 20

• Be going to receive chemotherapy and in hospital at least one week.

• Those Who willing to participate in the research

Exclusion Criteria:

• Physician consider the patient was not suitable

• Patients' limbs can not move

• Patients' conscious was unclear during hospitalization

• Patient with pain of joint and can't do 30-second chair stand test and 6-Minute Walking Test

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Leukemia

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,