Chronic Heart Failure (CHF)NCT01197313
Depression and Quality of Life in Chronic Heart Failure Patients and the Caregivers
A study testing Home-based exercise in people with Chronic Heart Failure (CHF) and Anxiety and Depression, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Heart Failure (CHF), Anxiety and Depression, Quality of Life (QOL)
- What is being tested?
- Home-based exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2006to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of CHF for more than 6 months (NYHA Classes I-III)
- Medically stable for at least 3 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Home-based exercise
- Keywords
- chronic heart failure (CHF); anxiety and depression; quality of life (QOL); exercise
- Medical subject headings
- Anxiety Disorders, Depression, Motor Activity, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based exerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Not described Receives: Other: Home-based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychologic aspect
Anxiety and depression was measured by Hospital Anxiety and Depression Scale (HADS).
Measured: 8 weeks
Functional capacity
Functional capacity was assessed by six-minute walk test (6MWT).
Measured: 8 weeks
Disability level
Groningen Activity Restriction Scale (GARS)
Measured: 8 weeks
Quality of life
Minnesota Living with Heart Failure Questionnaire (MHFQ) was used to assess quality of life.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startDec 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart Failure (CHF)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ying-Tai Wu, Ph.D, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197313
- Sponsor's protocol ID
- 9561709097
- Status last verified
- Sep 2010
- First submitted
- 7 Sep 2010
- Last updated
- 9 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21843830
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression and Quality of Life in Chronic Heart Failure Patients and the Caregivers
- ClinicalTrials.gov ID
- NCT01197313
- Acronym / sponsor ID
- 9561709097
- Keywords
- chronic heart failure (CHF); anxiety and depression; quality of life (QOL); exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: Home-based exercise |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of CHF for more than 6 months (NYHA Classes I-III)
- Medically stable for at least 3 months
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based exercise | Other | Exercise |
Primary outcome
Psychologic aspect
Time frame: 8 weeks
Anxiety and depression was measured by Hospital Anxiety and Depression Scale (HADS).
Functional capacity
Time frame: 8 weeks
Functional capacity was assessed by six-minute walk test (6MWT).
Disability level
Time frame: 8 weeks
Groningen Activity Restriction Scale (GARS)
Quality of life
Time frame: 8 weeks
Minnesota Living with Heart Failure Questionnaire (MHFQ) was used to assess quality of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2010.
- Derived from this study: PubMed 21843830Chien 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying-Tai Wu, Ph.D principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based exercise in people with Chronic Heart Failure (CHF) and Anxiety and Depression, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychologic aspect (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01197313, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2010.