Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Depression and Quality of Life in Chronic Heart Failure Patients and the Caregivers

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01197313
First received: September 7, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Chronic Heart Failure (CHF)
Anxiety and Depression
Quality of Life (QOL)
Exercise
 Other: Home-based exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Depression and Quality of Life in Chronic Heart Failure Patients and the Caregivers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Psychologic aspect [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Anxiety and depression was measured by Hospital Anxiety and Depression Scale (HADS).

  • Functional capacity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Functional capacity was assessed by six-minute walk test (6MWT).

  • Disability level [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Groningen Activity Restriction Scale (GARS)

  • Quality of life [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Minnesota Living with Heart Failure Questionnaire (MHFQ) was used to assess quality of life.
Enrollment: 51
Study Start Date: December 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise Other: Home-based exercise

  Eligibility
Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197313

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Ying-Tai Wu, Ph.D National Taiwan University Hospital
  More Information

No publications provided by National Taiwan University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ying-Tai Wu/ Associate professor, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
ClinicalTrials.gov Identifier: NCT01197313     History of Changes
Other Study ID Numbers: 9561709097
Study First Received: September 7, 2010
Last Updated: September 7, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
chronic heart failure (CHF); anxiety and depression; quality of life (QOL); exercise

Additional relevant MeSH terms:
Depression
Depressive Disorder
Heart Failure
Behavioral Symptoms
 Cardiovascular Diseases
Heart Diseases
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on February 25, 2015