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.
Behavioral: Home-based cardiac rehabilitation
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.

Sponsor

Taichung Veterans General Hospital

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

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CG13107

Plan for Individual participant data (IPD)

Study Data/Documents

  1. 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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