Hepatitis CNCT00643695
Efficacy of an Exercise Intervention to Decrease Depressive Symptoms in Veterans With Hepatitis C
A study testing Home-based walking program and Educational intervention in people with Hepatitis C and Depression, run by Portland VA Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Depression
- What is being tested?
- Home-based walking program and Educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Home-based walking program, Educational intervention
- Keywords
- hepatitis C, depression, exercise
- Medical subject headings
- Hepatitis C, Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based walking programBehavioural
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 interventionOther
Participants in the control group will receive a packet of information regarding hepatitis C
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Home-based walking program Receives: Behavioral: Home-based walking program |
| 2 | Other | educational intervention Receives: Other: Educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of symptoms of depression as measured by the Beck Depression Inventory II (BDI-II)
Measured: 12 weeks
Secondary outcomes (2)
Reduction in symptoms of fatigue as measured by the Brief Fatigue Inventory (BFI)
Measured: 12 weeks
reduce the reported level of chronic pain
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portland VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Patricia Taylor-Young, Portland VA Medical Center
- Investigators
- Patricia Taylor-Young, PhD, RN,FNP, Principal investigator, Portland VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643695
- Sponsor's protocol ID
- 02101
- Status last verified
- Mar 2016
- First submitted
- 20 Mar 2008
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Exercise Intervention to Decrease Depressive Symptoms in Veterans With Hepatitis C
- ClinicalTrials.gov ID
- NCT00643695
- Acronym / sponsor ID
- 02101
- Conditions
- Hepatitis C, Depression
- Keywords
- hepatitis C, depression, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Portland VA Medical CenterUS federal agency
- Study start
- Mar 2008
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 26 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Home-based walking programHome-based walking program |
| 2 | Other | Other: Educational interventioneducational intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based walking programThe 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. | Behavioural | 1 |
| Educational interventionParticipants in the control group will receive a packet of information regarding hepatitis C | Other | 2 |
Primary outcome
Reduction of symptoms of depression as measured by the Beck Depression Inventory II (BDI-II)
Time frame: 12 weeks
2 secondary outcomes
Reduction in symptoms of fatigue as measured by the Brief Fatigue Inventory (BFI)
Time frame: 12 weeks
reduce the reported level of chronic pain
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Taylor-Young, PhD, RN,FNP principal investigator
Portland VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based walking program and Educational intervention in people with Hepatitis C and Depression, run by Portland VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of symptoms of depression as measured by the Beck Depression Inventory II (BDI-II) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2016; AzTrials last refreshed its copy on 28 Oct 2026.