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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00643695
• Other study ID #: 02101
• Status: Completed
• Phase: N/A
• First received: March 20, 2008
• Last updated: March 28, 2016
• Start date: March 2008
• Est. completion date: October 2014

Study information

• Verified date: March 2016
• Source: Portland VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

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.

Other:
• Educational intervention
Participants in the control group will receive a packet of information regarding hepatitis C

Locations

Country	Name	City	State
United States	Portland VA Medical Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Portland VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of symptoms of depression as measured by the Beck Depression Inventory II (BDI-II)		12 weeks	No
Secondary	Reduction in symptoms of fatigue as measured by the Brief Fatigue Inventory (BFI)		12 weeks	No
Secondary	reduce the reported level of chronic pain		12 weeks	No