Effects of Exercise Training on Fluid Instability in Heart Failure Patients

May 18, 2020 updated by: VA Office of Research and Development
Heart Failure (HF) is a significant healthcare concern in the US, with a 120% rise in mortality rates over 15 years costing the country an estimated $37.2 billion in 2009. Veterans are currently impacted at a rate of 5.2%, and cost an average of $14,959/individual/year for those utilizing the VA's Healthcare services. Research has shown that exercise training (ET) improves aerobic capacity, endothelial dysfunction, quality of life, and the ability to tolerate activity within the overall HF population. The purpose of this study is to examine the effects of structured exercise training and specific types of exercise training, walking, bicycling, and resistance training, on the symptom of fluid volume over load or edema in advanced heart failure patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Heart Failure (HF) is a significant healthcare concern in the US, with a 120% rise in mortality rates over 15 years costing the country an estimated $37.2 billion in 2009. Veterans are currently impacted at a rate of 5.2%, and cost an average of $14,959/individual/year for those utilizing the VA's Healthcare services. Research has shown that exercise training (ET) improves aerobic capacity, endothelial dysfunction, quality of life, and the ability to tolerate activity within the overall HF population. Animal models have emerged to explain some of the underlying mechanisms for the pathologic expression of symptoms and the links to ET. A translational link has not yet been explored between the animal models and human symptom expression.

Objectives: The long-term goal of this research program is to develop an exercise training (ET) program that effectively decreases fluid shift variability in HF patients, while being safely implemented in the home environment and remotely monitored by a healthcare provider within a nurse-lead HF Clinic. The purpose of the proposed research project is to determine if ET alters fluid status of patients with HF as compared to those under standard treatment of care. The central hypothesis is that a combined weight-bearing aerobic and resistance ET protocol will reduce (stabilize) 24-hour weight and bioelectrical impedance patterns of variability, as evaluated via mixed-effects regression modeling, greater than any other form of ET protocol.

Methods: Design: Using established experimental design techniques implemented in an innovative manner, a between-group design is used within the experimental arm employing a single subject, multiple-baseline design. The use of such technique allows for the subjects to be their own controls, while also allowing for statistical between group comparisons.

Subjects and Setting: 60 subjects meeting inclusion/exclusion criteria will be enrolled from the VA HF Clinic and outpatient VA cardiology clinics within 50 miles of Columbia, South Carolina. Subjects will be randomized to the exercise or usual care groups.

Procedures: The exercise protocol lasts 12 weeks, with subjects being randomized to order of ET. Weight-bearing aerobic ET will be walking on a treadmill; non-weight-bearing aerobic ET will be stationary bicycling; and resistance ET will be lower body isolation ET. Fluid stability is the concept of day-to-day variability of movement of intra-cellular fluid to extra-cellular space. Fluid stability will be assessed using 24-hour weight and bioelectrical impedance and quantified statistically using mixed effect modeling.

Data Analysis: Statistical analysis will utilize a longitudinal mixed-effects regression model, modeling variability over time for the subjects individually, as well as within groups. Additionally, main effects (time and group) and interaction effects (time by group) will be assessed.

Status: Funding began September 1, 2010. The study was transferred to Dorn VAMC in Columbia, SC in March of 2011. Currently the study is in the final phase of data analysis.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29209
        • Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Advanced Heart Failure
  • Ability to Walk
  • Over 21

Exclusion Criteria:

  • Renal Failure
  • Inability to walk
  • Physician exclusion

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Experimental: Exercise
Exercise: Walking Strength Training Bicycling
Other: Exercise
Walking Strength Training Bicycling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioelectrical Impedance Change
Time Frame: baseline, week 16, week 24
The extracellular fluid was calculated and reported to demonstrate Fluid Instability. A Bioelectrical Impedance Monitor was utilized to attain these measures.
baseline, week 16, week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight Change
Time Frame: baseline, week 16, week 24
Body weight was assessed via a home weight scale. Patients recorded their morning body weight in pounds up to 1 decimal point. The daily values were then used to create a weekly standard deviation to represent variability of daily weight. The standard deviation was then meaned for phase of the study. The values reported represent absolute weight means across participants.
baseline, week 16, week 24
Health Outcome Measures Change
Time Frame: baseline, week 16, week 24
Health Outcomes were measured with a Daily Heart Failure Symptom Questionnaire. The likert scale was converted to a continuous scale ranging from 0-15 for each of the 10 questions. The higher scores are more indicative of active HF symptoms while lower scores are lack of active HF symptoms. Range for this total score is 0-150.
baseline, week 16, week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Andrea M Boyd, PhD, Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC

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

November 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 8, 2010

First Submitted That Met QC Criteria

June 15, 2011

First Posted (Estimate)

June 17, 2011

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

May 18, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRI 09-228

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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