- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02928783
Evaluation of Exercise Tolerance and Cardiac Output in Patients With Heart Failure After Intervention of Rehabilitation Program
October 6, 2016 updated by: Jin Long Huang, Taichung Veterans General Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
37
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Heart failure patients with NYHA I, II, III, and LVEF<50%.
Exclusion Criteria:
- Heart failure patients with NYHA I, II, III, and LVEF<50%. But excluded pregnancy, disability.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
In interventional group, we arranged individualized rehabilitation programs including home-based cardiac rehabilitation, diet education and management of daily activity for 3 months.
|
|
No Intervention: Control
We didn't arrange individualized rehabilitation programs including home-based cardiac rehabilitation, diet education and management of daily activity for 3 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months
|
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.
|
3 months
|
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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
readmission rate
Time Frame: 90 days
|
All participants the assessment of 90-day readmission rate after completing an 3 months training programs.
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- O'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.
- Tomczak 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.
- Smart 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.
- Schmidt 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.
- Suttner 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
September 4, 2016
First Submitted That Met QC Criteria
October 6, 2016
First Posted (Estimate)
October 10, 2016
Study Record Updates
Last Update Posted (Estimate)
October 10, 2016
Last Update Submitted That Met QC Criteria
October 6, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CG13107
Plan for Individual participant data (IPD)
Study Data/Documents
-
Individual Participant Data Set
Information comments: Data set
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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