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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00643695
Enrollment
14
Registered
2008-03-26
Start date
2008-03-31
Completion date
2014-10-31
Last updated
2016-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Hepatitis C

Keywords

hepatitis C, depression, exercise

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.

Interventions

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

Sponsors

Portland VA Medical Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Reduction in symptoms of fatigue as measured by the Brief Fatigue Inventory (BFI)12 weeks
reduce the reported level of chronic pain12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026