Effects of Activity and Education Program on Patients With Chronic Hepatitis C Infection
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|ClinicalTrials.gov Identifier: NCT01572233|
Recruitment Status : Unknown
Verified November 2012 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : April 6, 2012
Last Update Posted : December 27, 2012
This 4-year project will be guided by a biobehavioral model for the study of exercise interventions in two phases with the purposes to :
- explore the patients' physical activity preferences and develop doable activity lists during treatment period
- examine the changes of health-related physical fitness component over interferon treatment
- develop the Personalized Physical Activity and Psych-Education (PPAPE) Program and test its effects on decreasing fatigue, physical and psychological distress, and improving their health-related physical fitness and quality of life in patients with chronic hepatitis C receiving Interferon with Ribavirin Combination Therapy
- evaluate the outcome of the PPAPE program on increasing adherence to therapy, the sustained virological response (SVR) in 24 weeks after the end of treatment, and the time-consuming for education program during intervention.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Virus Infection, Response to Therapy of||Behavioral: Personalized Physical Activity and Psycho-Education (PPAPE) Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effects of Personalized Physical Activity and Psycho-Education Program on Patients With Chronic Hepatitis C Infection|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||June 2018|
Experimental: Patient with HCV Infection
Personalized Physical Activity and Psycho-Education (PPAPE) Program will be tested on this group.
Behavioral: Personalized Physical Activity and Psycho-Education (PPAPE) Program
No Intervention: usual care
waiting list group with usual care
- Effects of Activity and Education Program on Patients with Chronic Hepatitis C Infection [ Time Frame: 4-year project ]Phase I of this project, the first and second year, the measurement time will be collected on the baseline (before treatment, T0), the 8 weeks (T1), 16 weeks (T2), and 24 weeks (T3) during treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572233
|Contact: Siow-ching Shun, PhD||886-2-23123456 ext email@example.com|
|National Taiwan University Hospital||Recruiting|
|Contact: Shiow-Ching Shun, PhD 886-2-23123456 ext 88439 firstname.lastname@example.org|
|Principal Investigator: Shiow-Ching Shun, PhD|
|Principal Investigator:||Shiow-ching Shun, PhD||National Taiwan University|