Heart Failure With or Without CRT-P/DNCT02928783
Evaluation of Exercise Tolerance and Cardiac Output in Patients With Heart Failure After Intervention of Rehabilitation Program
A study testing Home-based cardiac rehabilitation in people with Heart Failure With or Without CRT-P/D, run by Taichung Veterans General Hospital.
Trial summary
Home-based rehabilitation programs have not been widely few been studied and the training effects are not unclear. This study evaluates the beneficial effects of home-based cardiac rehabilitation on quality of medical care in patients with chronic heart failure. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Heart Failure With or Without CRT-P/D
- What is being tested?
- Home-based cardiac rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Mar 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart failure patients with NYHA I, II, III, and LVEF<50%.
Who cannot join
- Heart failure patients with NYHA I, II, III, and LVEF<50%. But excluded pregnancy, disability.
About this study
Home-based rehabilitation programs have not been widely few been studied and the training effects are not unclear. This study evaluates the beneficial effects of home-based cardiac rehabilitation on quality of medical care in patients with chronic heart failure.
Read the detailed description
cardiopulmonary rehabilitation programs are safe and effective for improving functional capacity, quality of life, as well as for reducing in the re-admission rate and all-cause mortality of patients with heart failure.clinical trials that have established the benefits of hospital-based cardiac rehabilitation for patients with chronic heart failure. Home-based cardiac rehabilitation could be more accessible and acceptable compared with hospital-based cardiac rehabilitation.
- Conditions
- Heart Failure With or Without CRT-P/D
- Being tested
- Home-based cardiac rehabilitation
- Keywords
- Home-based cardiac rehabilitation, Quality of Medical Care, Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based cardiac rehabilitationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In interventional group, we arranged individualized rehabilitation programs including home-based cardiac rehabilitation, diet education and management of daily activity for 3 months. Receives: Behavioral: Home-based cardiac rehabilitation |
| Control | No intervention | We didn't arrange individualized rehabilitation programs including home-based cardiac rehabilitation, diet education and management of daily activity for 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline peak oxygen uptake (ml /kg/min) at 3 months
All participants the assessment of cardiopulmonary exercise test at baseline and after completing an 3 months training programs.
Measured: 3 months
Change from Baseline quality of life at 3 months
All participants the assessment of Minnesota Living With HF Questionnaire (MLHFQ) at baseline and after completing an 3 months training programs.
Measured: 3 months
Change from Baseline 6-min walking distance (6MWD) at 3 months
All participants the assessment of 6-min walk test at baseline and after completing an 3 months training programs.
Measured: 3 months
Secondary outcomes (1)
readmission rate
All participants the assessment of 90-day readmission rate after completing an 3 months training programs.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startJun 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With or Without CRT-P/DStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Long Huang, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928783
- Sponsor's protocol ID
- CG13107
- Status last verified
- Oct 2016
- First submitted
- 4 Sep 2016
- Last updated
- 10 Oct 2016
- Results posted
- No
Publications
Haykowsky MJ, Liang Y, Pechter D, Jones LW, McAlister FA, Clark AM. A meta-analysis of the effect of exercise training on left ventricular remodeling in heart failure patients: the benefit depends on the type of training performed. J Am Coll Cardiol. 2007 Jun 19;49(24):2329-36. doi: 10.1016/j.jacc.2007.02.055. Epub 2007 Jun 4.
PubMed 17572248O'Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Miller NH, Fleg JL, Schulman KA, McKelvie RS, Zannad F, Pina IL; HF-ACTION Investigators. Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1439-50. doi: 10.1001/jama.2009.454.
PubMed 19351941Tomczak CR, Thompson RB, Paterson I, Schulte F, Cheng-Baron J, Haennel RG, Haykowsky MJ. Effect of acute high-intensity interval exercise on postexercise biventricular function in mild heart failure. J Appl Physiol (1985). 2011 Feb;110(2):398-406. doi: 10.1152/japplphysiol.01114.2010. Epub 2010 Nov 18.
PubMed 21088202Smart NA, Steele M. A comparison of 16 weeks of continuous vs intermittent exercise training in chronic heart failure patients. Congest Heart Fail. 2012 Jul-Aug;18(4):205-11. doi: 10.1111/j.1751-7133.2011.00274.x. Epub 2011 Nov 27.
PubMed 22809258Schmidt C, Theilmeier G, Van Aken H, Korsmeier P, Wirtz SP, Berendes E, Hoffmeier A, Meissner A. Comparison of electrical velocimetry and transoesophageal Doppler echocardiography for measuring stroke volume and cardiac output. Br J Anaesth. 2005 Nov;95(5):603-10. doi: 10.1093/bja/aei224. Epub 2005 Sep 9.
PubMed 16155037Suttner S, Schollhorn T, Boldt J, Mayer J, Rohm KD, Lang K, Piper SN. Noninvasive assessment of cardiac output using thoracic electrical bioimpedance in hemodynamically stable and unstable patients after cardiac surgery: a comparison with pulmonary artery thermodilution. Intensive Care Med. 2006 Dec;32(12):2053-8. doi: 10.1007/s00134-006-0409-x. Epub 2006 Oct 13.
PubMed 17039348
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Exercise Tolerance and Cardiac Output in Patients With Heart Failure After Intervention of Rehabilitation Program
- ClinicalTrials.gov ID
- NCT02928783
- Acronym / sponsor ID
- CG13107
- Conditions
- Heart Failure With or Without CRT-P/D
- Keywords
- Home-based cardiac rehabilitation, Quality of Medical Care, Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 10 Oct 2016 (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.
Home-based rehabilitation programs have not been widely few been studied and the training effects are not unclear. This study evaluates the beneficial effects of home-based cardiac rehabilitation on quality of medical care in patients with chronic heart failure.
Detailed description
cardiopulmonary rehabilitation programs are safe and effective for improving functional capacity, quality of life, as well as for reducing in the re-admission rate and all-cause mortality of patients with heart failure.clinical trials that have established the benefits of hospital-based cardiac rehabilitation for patients with chronic heart failure. Home-based cardiac rehabilitation could be more accessible and acceptable compared with hospital-based cardiac rehabilitation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Home-based cardiac rehabilitationIn interventional group, we arranged individualized rehabilitation programs including home-based cardiac rehabilitation, diet education and management of daily activity for 3 months. |
| Control | No intervention | –We didn't arrange individualized rehabilitation programs including home-based cardiac rehabilitation, diet education and management of daily activity for 3 months. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Heart failure patients with NYHA I, II, III, and LVEF<50%.
Key exclusion criteria (1 listed)
- Heart failure patients with NYHA I, II, III, and LVEF<50%. But excluded pregnancy, disability.
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 cardiac rehabilitation | Behavioural | Intervention |
Primary outcome
Change from Baseline peak oxygen uptake (ml /kg/min) at 3 months
Time frame: 3 months
All participants the assessment of cardiopulmonary exercise test at baseline and after completing an 3 months training programs.
Change from Baseline quality of life at 3 months
Time frame: 3 months
All participants the assessment of Minnesota Living With HF Questionnaire (MLHFQ) at baseline and after completing an 3 months training programs.
Change from Baseline 6-min walking distance (6MWD) at 3 months
Time frame: 3 months
All participants the assessment of 6-min walk test at baseline and after completing an 3 months training programs.
1 secondary outcome
readmission rate
Time frame: 90 days
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 10 Oct 2016.
- Results publication: PubMed 17572248Haykowsky MJ, Liang Y, Pechter D, Jones LW, McAlister FA, Clark AM. A meta-analysis of the effect of exercise training on left ventricular remodeling in heart failure patients: the benefit depends on the type of training performed. J Am Coll Cardiol. 2007 Jun 19;49(24):2329-36. doi: 10.1016/j.jacc.2007.02.055. Epub 2007 Jun 4.
- Results publication: PubMed 19351941O'Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Miller NH, Fleg JL, Schulman KA, McKelvie RS, Zannad F, Pina IL; HF-ACTION Investigators. Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1439-50. doi: 10.1001/jama.2009.454.
- Results publication: PubMed 21088202Tomczak CR, Thompson RB, Paterson I, Schulte F, Cheng-Baron J, Haennel RG, Haykowsky MJ. Effect of acute high-intensity interval exercise on postexercise biventricular function in mild heart failure. J Appl Physiol (1985). 2011 Feb;110(2):398-406. doi: 10.1152/japplphysiol.01114.2010. Epub 2010 Nov 18.
- Results publication: PubMed 22809258Smart NA, Steele M. A comparison of 16 weeks of continuous vs intermittent exercise training in chronic heart failure patients. Congest Heart Fail. 2012 Jul-Aug;18(4):205-11. doi: 10.1111/j.1751-7133.2011.00274.x. Epub 2011 Nov 27.
- Results publication: PubMed 16155037Schmidt C, Theilmeier G, Van Aken H, Korsmeier P, Wirtz SP, Berendes E, Hoffmeier A, Meissner A. Comparison of electrical velocimetry and transoesophageal Doppler echocardiography for measuring stroke volume and cardiac output. Br J Anaesth. 2005 Nov;95(5):603-10. doi: 10.1093/bja/aei224. Epub 2005 Sep 9.
- Results publication: PubMed 17039348Suttner S, Schollhorn T, Boldt J, Mayer J, Rohm KD, Lang K, Piper SN. Noninvasive assessment of cardiac output using thoracic electrical bioimpedance in hemodynamically stable and unstable patients after cardiac surgery: a comparison with pulmonary artery thermodilution. Intensive Care Med. 2006 Dec;32(12):2053-8. doi: 10.1007/s00134-006-0409-x. Epub 2006 Oct 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based cardiac rehabilitation in people with Heart Failure With or Without CRT-P/D, run by Taichung Veterans General Hospital.
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 1 inclusion and 1 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 10 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from Baseline peak oxygen uptake (ml /kg/min) at 3 months (time frame: 3 months). The study lists 3 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 NCT02928783, which also lists 6 linked publications.
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 10 Oct 2016; AzTrials last refreshed its copy on 7 Nov 2026.