Evaluation of Exercise Tolerance and Cardiac Output in Patients With Heart Failure After Intervention of Rehabilitation Program
Primary Purpose
Heart Failure With or Without CRT-P/D
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Home-based cardiac rehabilitation
Sponsored by

About this trial
This is an interventional health services research trial for Heart Failure With or Without CRT-P/D focused on measuring Home-based cardiac rehabilitation, Quality of Medical Care, Heart Failure
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
In interventional group, we arranged individualized rehabilitation programs including home-based cardiac rehabilitation, diet education and management of daily activity for 3 months.
We didn't arrange individualized rehabilitation programs including home-based cardiac rehabilitation, diet education and management of daily activity for 3 months.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
readmission rate
All participants the assessment of 90-day readmission rate after completing an 3 months training programs.
Full Information
NCT ID
NCT02928783
First Posted
September 4, 2016
Last Updated
October 6, 2016
Sponsor
Taichung Veterans General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02928783
Brief Title
Evaluation of Exercise Tolerance and Cardiac Output in Patients With Heart Failure After Intervention of Rehabilitation Program
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taichung Veterans General Hospital
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With or Without CRT-P/D
Keywords
Home-based cardiac rehabilitation, Quality of Medical Care, Heart Failure
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
In interventional group, we arranged individualized rehabilitation programs including home-based cardiac rehabilitation, diet education and management of daily activity for 3 months.
Arm Title
Control
Arm Type
No Intervention
Arm Description
We didn't arrange individualized rehabilitation programs including home-based cardiac rehabilitation, diet education and management of daily activity for 3 months.
Intervention Type
Behavioral
Intervention Name(s)
Home-based cardiac rehabilitation
Primary Outcome Measure Information:
Title
Change from Baseline peak oxygen uptake (ml /kg/min) at 3 months
Description
All participants the assessment of cardiopulmonary exercise test at baseline and after completing an 3 months training programs.
Time Frame
3 months
Title
Change from Baseline quality of life at 3 months
Description
All participants the assessment of Minnesota Living With HF Questionnaire (MLHFQ) at baseline and after completing an 3 months training programs.
Time Frame
3 months
Title
Change from Baseline 6-min walking distance (6MWD) at 3 months
Description
All participants the assessment of 6-min walk test at baseline and after completing an 3 months training programs.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
readmission rate
Description
All participants the assessment of 90-day readmission rate after completing an 3 months training programs.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
17572248
Citation
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.
Results Reference
result
PubMed Identifier
19351941
Citation
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.
Results Reference
result
PubMed Identifier
21088202
Citation
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.
Results Reference
result
PubMed Identifier
22809258
Citation
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.
Results Reference
result
PubMed Identifier
16155037
Citation
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.
Results Reference
result
PubMed Identifier
17039348
Citation
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.
Results Reference
result
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Evaluation of Exercise Tolerance and Cardiac Output in Patients With Heart Failure After Intervention of Rehabilitation Program
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