Effects of Activity and Education Program on Patients With Chronic Hepatitis C Infection

Not Applicable

• Conditions: Hepatitis C Virus Infection, Response to Therapy of
• Interventions: Behavioral: Personalized Physical Activity and Psycho-Education (PPAPE) Program

• Registration Number: NCT01572233
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

This 4-year project will be guided by a biobehavioral model for the study of exercise interventions in two phases with the purposes to :

1. explore the patients' physical activity preferences and develop doable activity lists during treatment period

2. examine the changes of health-related physical fitness component over interferon treatment

3. 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

4. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-04-04
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-06
• Status Verified: 2012-11
• Last Update Submitted: 2012-12-26
• Last Update Posted: 2012-12-27
• Primary Completion: 2017-12
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients with Chronic Hepatitis C Infection Receiving Interferon Therapy
• Aged above 18

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient with HCV Infection	Personalized Physical Activity and Psycho-Education (PPAPE) Program	Personalized Physical Activity and Psycho-Education (PPAPE) Program will be tested on this group.

Primary Outcome Measures

Name	Time	Method
Effects of Activity and Education Program on Patients with Chronic Hepatitis C Infection	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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan