- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01197313
Depression and Quality of Life in Chronic Heart Failure Patients and the Caregivers
September 7, 2010 updated by: National Taiwan University Hospital
Anxiety and depression are often present in patients with chronic heart failure (CHF).
This study aimed to evaluate the influence of anxiety and depression on the physical function, disability, and quality of life (QOL) in CHF.
This study examined the effects of 8-week home-based exercise on these parameters, and investigated the correlations between these outcome changes.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 100
- National Taiwan University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of CHF for more than 6 months (NYHA Classes I-III)
- Medically stable for at least 3 months
Exclusion Criteria:
- Malignancy
- Psychiatric disease, primary neuromusculoskeletal or respiratory diseases that affected the assessment of functional or exercise capacity
- Changes in medication occurred during the study period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychologic aspect
Time Frame: 8 weeks
|
Anxiety and depression was measured by Hospital Anxiety and Depression Scale (HADS).
|
8 weeks
|
Functional capacity
Time Frame: 8 weeks
|
Functional capacity was assessed by six-minute walk test (6MWT).
|
8 weeks
|
Disability level
Time Frame: 8 weeks
|
Groningen Activity Restriction Scale (GARS)
|
8 weeks
|
Quality of life
Time Frame: 8 weeks
|
Minnesota Living with Heart Failure Questionnaire (MHFQ) was used to assess quality of life.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
September 7, 2010
First Submitted That Met QC Criteria
September 7, 2010
First Posted (Estimate)
September 9, 2010
Study Record Updates
Last Update Posted (Estimate)
September 9, 2010
Last Update Submitted That Met QC Criteria
September 7, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9561709097
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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