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

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ClinicalTrials.gov Identifier: NCT01197313
Recruitment Status : Completed
First Posted : September 9, 2010
Last Update Posted : September 9, 2010
Sponsor:
Information provided by:
National Taiwan University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure (CHF) Anxiety and Depression Quality of Life (QOL) Exercise Other: Home-based exercise Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Depression and Quality of Life in Chronic Heart Failure Patients and the Caregivers
Study Start Date : December 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Exercise Other: Home-based exercise


Outcome Measures
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Primary Outcome Measures :
  1. Psychologic aspect [ Time Frame: 8 weeks ]
    Anxiety and depression was measured by Hospital Anxiety and Depression Scale (HADS).

  2. Functional capacity [ Time Frame: 8 weeks ]
    Functional capacity was assessed by six-minute walk test (6MWT).

  3. Disability level [ Time Frame: 8 weeks ]
    Groningen Activity Restriction Scale (GARS)

  4. Quality of life [ Time Frame: 8 weeks ]
    Minnesota Living with Heart Failure Questionnaire (MHFQ) was used to assess quality of life.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: September 9, 2010    Key Record Dates
Last Update Posted: September 9, 2010
Last Verified: September 2010

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
 Mood Disorders
Mental Disorders
Heart Diseases
Cardiovascular Diseases