Back to resultsDepression and Quality of Life in Chronic Heart Failure Patients and the Caregivers
Primary Purpose
Chronic Heart Failure (CHF), Anxiety and Depression, Quality of Life (QOL)
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Home-based exercise
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure (CHF) focused on measuring chronic heart failure (CHF); anxiety and depression; quality of life (QOL); exercise
Eligibility Criteria
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
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise
Arm Description
Outcomes
Primary Outcome Measures
Psychologic aspect
Anxiety and depression was measured by Hospital Anxiety and Depression Scale (HADS).
Functional capacity
Functional capacity was assessed by six-minute walk test (6MWT).
Disability level
Groningen Activity Restriction Scale (GARS)
Quality of life
Minnesota Living with Heart Failure Questionnaire (MHFQ) was used to assess quality of life.
Secondary Outcome Measures
Full Information
NCT ID
NCT01197313
First Posted
September 7, 2010
Last Updated
September 7, 2010
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01197313
Brief Title
Depression and Quality of Life in Chronic Heart Failure Patients and the Caregivers
Official Title
Depression and Quality of Life in Chronic Heart Failure Patients and the Caregivers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure (CHF), Anxiety and Depression, Quality of Life (QOL), Exercise
Keywords
chronic heart failure (CHF); anxiety and depression; quality of life (QOL); exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Home-based exercise
Primary Outcome Measure Information:
Title
Psychologic aspect
Description
Anxiety and depression was measured by Hospital Anxiety and Depression Scale (HADS).
Time Frame
8 weeks
Title
Functional capacity
Description
Functional capacity was assessed by six-minute walk test (6MWT).
Time Frame
8 weeks
Title
Disability level
Description
Groningen Activity Restriction Scale (GARS)
Time Frame
8 weeks
Title
Quality of life
Description
Minnesota Living with Heart Failure Questionnaire (MHFQ) was used to assess quality of life.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying-Tai Wu, Ph.D
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
21843830
Citation
Chien CL, Lee CM, Wu YW, Wu YT. Home-based exercise improves the quality of life and physical function but not the psychological status of people with chronic heart failure: a randomised trial. J Physiother. 2011;57(3):157-63. doi: 10.1016/S1836-9553(11)70036-4.
Results Reference
derived
Learn more about this trial
Depression and Quality of Life in Chronic Heart Failure Patients and the Caregivers
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