NCT01197313

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
Last Updated

September 9, 2010

Status Verified

September 1, 2010

Enrollment Period

1 year

First QC Date

September 7, 2010

Last Update Submit

September 7, 2010

Conditions

Keywords

chronic heart failure (CHF); anxiety and depression; quality of life (QOL); exercise

Outcome Measures

Primary Outcomes (4)

  • Psychologic aspect

    Anxiety and depression was measured by Hospital Anxiety and Depression Scale (HADS).

    8 weeks

  • Functional capacity

    Functional capacity was assessed by six-minute walk test (6MWT).

    8 weeks

  • Disability level

    Groningen Activity Restriction Scale (GARS)

    8 weeks

  • Quality of life

    Minnesota Living with Heart Failure Questionnaire (MHFQ) was used to assess quality of life.

    8 weeks

Study Arms (1)

Exercise

EXPERIMENTAL
Other: Home-based exercise

Interventions

Exercise

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of CHF for more than 6 months (NYHA Classes I-III)
  • Medically stable for at least 3 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Anxiety DisordersDepressionMotor ActivityHeart Failure

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorHeart DiseasesCardiovascular Diseases

Study Officials

  • Ying-Tai Wu, Ph.D

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2010

First Posted

September 9, 2010

Study Start

December 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

September 9, 2010

Record last verified: 2010-09

Locations