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Clinical Trials/NCT01572233
NCT01572233UnknownNot Applicable

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

National Taiwan University Hospital1 site in 1 country300 target enrollmentStarted: December 1, 2011Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
300
Locations
1
Primary Endpoint
Effects of Activity and Education Program on Patients with Chronic Hepatitis C Infection
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
20 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Patient with HCV Infection

Experimental

Personalized Physical Activity and Psycho-Education (PPAPE) Program will be tested on this group.

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

usual care

No Intervention

waiting list group with usual care

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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