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OpenTrials
Completed

NCT Number: NCT00643695

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

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.

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Key information

Conditions

Hepatitis C Behavior Behavioral Symptoms Blood-Borne Infections Communicable Diseases Depression Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Motor Activity RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Portland VA Medical Center

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

home-based walking program

Behavioral

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.

Educational Intervention

Other

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

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

Sponsors and collaborators

Lead sponsor

Portland VA Medical Center

Fed

Registry information

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Mar 26, 2008
Registry last updated
Mar 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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