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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01197313
Other study ID # 9561709097
Secondary ID
Status Completed
Phase N/A
First received September 7, 2010
Last updated September 7, 2010
Start date December 2006
Est. completion date December 2007

Study information

Verified date September 2010
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Intervention

Other:
Home-based exercise


Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Psychologic aspect Anxiety and depression was measured by Hospital Anxiety and Depression Scale (HADS). 8 weeks No
Primary Functional capacity Functional capacity was assessed by six-minute walk test (6MWT). 8 weeks No
Primary Disability level Groningen Activity Restriction Scale (GARS) 8 weeks No
Primary Quality of life Minnesota Living with Heart Failure Questionnaire (MHFQ) was used to assess quality of life. 8 weeks No
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