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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
Taichung Veterans General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 4, 2016
    Last Updated
    October 6, 2016
    Sponsor
    Taichung Veterans General Hospital
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    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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