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

NCT ID: NCT00643695

Last Updated: 2016-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2014-10-31

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.

Conditions

Hepatitis C; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Home-based walking program

Group Type: EXPERIMENTAL

Home-based walking program

Intervention Type: 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.

2

educational intervention

Group Type: OTHER

Educational intervention

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

Educational intervention

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Portland VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Patricia Taylor-Young

Nurse Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia Taylor-Young, PhD, RN,FNP

Role: PRINCIPAL_INVESTIGATOR

Portland VA Medical Center

Locations

Portland VA Medical Center

Portland, Oregon, United States

Countries

United States

Other Identifiers

02101

Identifier Type: -

Identifier Source: org_study_id