NCT02928783

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 10, 2016

Completed
Last Updated

October 10, 2016

Status Verified

October 1, 2016

Enrollment Period

9 months

First QC Date

September 4, 2016

Last Update Submit

October 6, 2016

Conditions

Heart Failure With or Without CRT-P/D

Keywords

Home-based cardiac rehabilitationQuality of Medical CareHeart Failure

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    3 months

Secondary Outcomes (1)

  • readmission rate

    90 days

Study Arms (2)

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.

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.

Interventions

Home-based cardiac rehabilitationBEHAVIORAL
Intervention

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heart failure patients with NYHA I, II, III, and LVEF\<50%.

You may not qualify if:

  • Heart failure patients with NYHA I, II, III, and LVEF\<50%. But excluded pregnancy, disability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 17572248RESULT

  • 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.

    PMID: 19351941RESULT

  • 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.

    PMID: 21088202RESULT

  • 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.

    PMID: 22809258RESULT

  • 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.

    PMID: 16155037RESULT

  • 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.

    PMID: 17039348RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., P.D

Study Record Dates

First Submitted

September 4, 2016

First Posted

October 10, 2016

Study Start

June 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

October 10, 2016

Record last verified: 2016-10