Efficacy of an Exercise Intervention to Decrease Depressive Symptoms in Veterans With Hepatitis C - Full Text View

Sponsored by:	Portland VA Medical Center
Information provided by:	Portland VA Medical Center
ClinicalTrials.gov Identifier:	NCT00643695

Purpose

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	Intervention
Hepatitis C Depression	Behavioral: Home-based walking program Other: Educational intervention

MedlinePlus related topics: Depression Exercise and Physical Fitness Hepatitis Hepatitis C

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of an Exercise Intervention to Decrease Depressive Symptoms in Veterans With Hepatitis C

Further study details as provided by Portland VA Medical Center:

Primary Outcome Measures:

Reduction of symptoms of depression as measured by the Beck Depression Inventory II (BDI-II) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction in symptoms of fatigue as measured by the Brief Fatigue Inventory (BFI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
reduce the reported level of chronic pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	56
Study Start Date:	March 2008
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: No Intervention	Other: Educational intervention Participants in the control group will receive a packet of information regarding hepatitis C

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643695

Locations

United States, Oregon
Portland VA Medical Center
Portland, Oregon, United States, 97239

Sponsors and Collaborators

Portland VA Medical Center

Investigators

Principal Investigator:

Patricia Taylor-Young, PhD, RN,FNP

Portland VA Medical Center

More Information

No publications provided

Responsible Party:	Portland VA Medical Center ( Patricia Taylor-Young PhD RN NP )
Study ID Numbers:	02101
Study First Received:	March 20, 2008
Last Updated:	March 20, 2008
ClinicalTrials.gov Identifier:	NCT00643695 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Portland VA Medical Center:

hepatitis C
depression
exercise

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Depression
Mental Disorders

Mood Disorders
Hepatitis, Viral, Human
Hepatitis C
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Liver Diseases
RNA Virus Infections
Depression
Flaviviridae Infections
Hepatitis, Viral, Human
Depressive Disorder
Behavioral Symptoms

Hepatitis
Virus Diseases
Digestive System Diseases
Mental Disorders
Mood Disorders
Hepatitis C

ClinicalTrials.gov processed this record on May 07, 2009