Efficacy of an Exercise Intervention to Decrease Depressive Symptoms in Veterans With Hepatitis C

March 28, 2016 updated by: Patricia Taylor-Young, Portland VA Medical Center

In this study, depressed veterans with hepatitis C will be randomly assigned to the control group or to the exercise intervention group. The exercise intervention is designed to begin slowly for most participants and to progress within each participant's target heart rate range for moderate intensity exercise. The exercise intervention is a 12 week home based walking program. Ideally individuals will walk for 30 minutes, at a moderate intensity, a minimum of three times per week. However, the duration and relative intensity will be tailored for each individual.

Central Hypothesis Veterans who receive the exercise intervention will be significantly less symptomatic for depression than veterans in the control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Portland VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, age 18 or older
  • Documentation of positive hepatitis C status as indicated by a detectable HCV viral load by polymerase chain reaction
  • Mild to moderate depressive symptoms as evidenced by a BDI II score of ≥ 14
  • Able to read and understand English
  • Written/signed informed consent specific to this protocol
  • Being sedentary that is , less than 30 minutes of planned low to moderate intensity exercise 2 days per week

Exclusion Criteria:

  • Suicidal ideations
  • Current interferon therapy or planning to begin interferon therapy during the next three months
  • Diagnosis of Bipolar disorder, Schizophrenia, or Post Traumatic Stress Disorder
  • Any medical condition, disorder, or medication that contraindicates participation in a mild to moderate intensity walking program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Home-based walking program
Behavioral: Home-based walking program
The exercise intervention is a 12 week home-based exercise program. Ideally Individuals will walk for 30 minutes, at a moderate intensity, a minimum of three times per week. However, the duration and relative intensity will be tailored for each individual.
Other: 2
educational intervention
Other: Educational intervention
Participants in the control group will receive a packet of information regarding hepatitis C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of symptoms of depression as measured by the Beck Depression Inventory II (BDI-II)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction in symptoms of fatigue as measured by the Brief Fatigue Inventory (BFI)
Time Frame: 12 weeks
12 weeks
reduce the reported level of chronic pain
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Portland VA Medical Center

Investigators

  • Principal Investigator: Patricia Taylor-Young, PhD, RN,FNP, Portland VA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

March 20, 2008

First Submitted That Met QC Criteria

March 20, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 28, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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