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CompletedNCT00643695Updated Mar 29, 2016

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

An interventional study of Home-based walking program and Educational intervention in Hepatitis C and Depression, sponsored by Portland VA Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-29.

Sponsored by Portland VA Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hepatitis C
  • Depression

Keywords

  • hepatitis C
  • depression
  • exercise
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 14 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Portland VA Medical Center is the lead sponsor of 18 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    1

    Home-based walking program

    Behavioral: Home-based walking program

  • Other
    2

    educational intervention

    Other: Educational intervention

Interventions

  • BehavioralHome-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.

  • OtherEducational intervention

    Participants in the control group will receive a packet of information regarding hepatitis C

06

What researchers measure

Primary outcomes

  1. Reduction of symptoms of depression as measured by the Beck Depression Inventory II (BDI-II)

    Time frame: 12 weeks

Secondary outcomes

  1. Reduction in symptoms of fatigue as measured by the Brief Fatigue Inventory (BFI)

    Time frame: 12 weeks

  2. reduce the reported level of chronic pain

    Time frame: 12 weeks

07

Study locations

1 site
  • Portland VA Medical Center
    Portland, Oregon 97239, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00643695
Lead sponsor
Portland VA Medical Center
Responsible party
Patricia Taylor-Young (Nurse Scientist, Portland VA Medical Center) — Principal investigator
First posted
Mar 26, 2008
Start date
Mar 2008
Primary completion
Oct 2014
Completion
Oct 2014
Last update
Mar 29, 2016

Study contacts

Patricia Taylor-Young, PhD, RN,FNP
principal investigator · Portland VA Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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