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

Primary Purpose

Hepatitis C, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-based walking program
Educational intervention
Sponsored by
Portland VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring hepatitis C, depression, exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Portland VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

Home-based walking program

educational intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Reduction in symptoms of fatigue as measured by the Brief Fatigue Inventory (BFI)
reduce the reported level of chronic pain

Full Information

First Posted
March 20, 2008
Last Updated
March 28, 2016
Sponsor
Portland VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00643695
Brief Title
Efficacy of an Exercise Intervention to Decrease Depressive Symptoms in Veterans With Hepatitis C
Official Title
Efficacy of an Exercise Intervention to Decrease Depressive Symptoms in Veterans With Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Portland VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Depression
Keywords
hepatitis C, depression, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Home-based walking program
Arm Title
2
Arm Type
Other
Arm Description
educational intervention
Intervention Type
Behavioral
Intervention Name(s)
Home-based walking program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Educational intervention
Intervention Description
Participants in the control group will receive a packet of information regarding hepatitis C
Primary Outcome Measure Information:
Title
Reduction of symptoms of depression as measured by the Beck Depression Inventory II (BDI-II)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Reduction in symptoms of fatigue as measured by the Brief Fatigue Inventory (BFI)
Time Frame
12 weeks
Title
reduce the reported level of chronic pain
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Taylor-Young, PhD, RN,FNP
Organizational Affiliation
Portland VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Portland VA Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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