Expired Study
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Portland, Oregon 97239


Purpose:

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.


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


Study is Available At:


Original ID:

02101


NCT ID:

NCT00643695


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Portland VA Medical Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

14


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:March 2008
Completion Date:October 2014
Completion Type:Actual
Primary Completion Date:October 2014
Primary Completion Type:Actual
Verification Date:March 2016
Last Changed Date:March 28, 2016
First Received Date:March 20, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:reduce the reported level of chronic pain
Time Frame:12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Reduction in symptoms of fatigue as measured by the Brief Fatigue Inventory (BFI)
Time Frame:12 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Reduction of symptoms of depression as measured by the Beck Depression Inventory II (BDI-II)
Time Frame:12 weeks
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Home-based walking program
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.
Arm Name:1
Intervention Type:Other
Name:Educational intervention
Description:Participants in the control group will receive a packet of information regarding hepatitis C
Arm Name:2

Study Arms

Study Arm Type:Other
Arm Name:2
Description:educational intervention
Study Arm Type:Experimental
Arm Name:1
Description:Home-based walking program

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Portland VA Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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