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

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Personalized Physical Activity and Psycho-Education Program on Patients With Chronic Hepatitis C Infection

Conditions
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Hepatitis C Virus Infection, Response to Therapy of

Intervention / Treatment
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* Behavioral: Personalized Physical Activity and Psycho-Education (PPAPE) Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Chronic Hepatitis C Infection Receiving Interferon Therapy Aged above 18 Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with HCV Infection<br>Personalized Physical Activity and Psycho-Education (PPAPE) Program will be tested on this group. | Behavioral: Personalized Physical Activity and Psycho-Education (PPAPE) Program<br>* Effects of Personalized Physical Activity and Psycho-Education Program on Patients with HCV infection The third and fourth year, will be examine on the 12, 24, 36, and 48 weeks during the interferon treatment.<br>|
| No Intervention: usual care<br>waiting list group with usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of Activity and Education Program on Patients with Chronic Hepatitis C Infection | 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. | 4-year project | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue,Physical Activity,Hepatitis C Virus Infection