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

NCT00643695 | Completed

• 1 other identifier: 02101
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Keywords

hepatitis C; depression; exercise

Outcome Measures

Primary Outcomes (1)

• Reduction of symptoms of depression as measured by the Beck Depression Inventory II (BDI-II)

  12 weeks

Secondary Outcomes (2)

• Reduction in symptoms of fatigue as measured by the Brief Fatigue Inventory (BFI)

  12 weeks

• reduce the reported level of chronic pain

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

Home-based walking program

Behavioral: Home-based walking program

2

OTHER

educational intervention

Other: Educational intervention

Interventions

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.

1

Educational intervention OTHER

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Portland VA Medical Center: lead

Study Sites (1)

Portland VA Medical Center

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Hepatitis C; Depression; Motor Activity

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Patricia Taylor-Young, PhD, RN,FNP

  Portland VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Scientist

Study Record Dates

• First Submitted: March 20, 2008
• First Posted: March 26, 2008
• Study Start: March 1, 2008
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 29, 2016

Record last verified: 2016-03

Locations

US (1)