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

Sponsor

Portland VA Medical Center (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00643695

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Depression	Behavioral: Home-based walking program Other: Educational intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Reduction of symptoms of depression as measured by the Beck Depression Inventory II (BDI-II) [12 weeks]

Secondary Outcome Measures

Reduction in symptoms of fatigue as measured by the Brief Fatigue Inventory (BFI) [12 weeks]
reduce the reported level of chronic pain [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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