Effects of Exercise Training on Fluid Instability in Heart Failure Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01375673
First received: October 8, 2010
Last updated: May 13, 2014
Last verified: May 2014

October 8, 2010
May 13, 2014
November 2011
August 2014   (final data collection date for primary outcome measure)
Bioelectrical Impedance [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
The total body water, intracellular fluid, and extracellular fluid will be calculated and reported to demonstrate Fluid Instability and Fluid Shift from intra to extra-cellular and from extra to intra-cellular. A Bioelectrical Impedance Monitor will be utilized to attain these measures.
Same as current
Complete list of historical versions of study NCT01375673 on ClinicalTrials.gov Archive Site
  • Body Weight [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
    Body weight will be assessed via an average home weight scale. Patients will record their morning body weight in lbs up to 1 decimal point. Additionally, a hospital scale will be used to measure body weight on each clinic visit.
  • Health Outcome Measures [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Health Outcomes will be measured using the Kansas City Cardio-myopathy Questionnaire, Heart Failure Symptom Questionnaire, and subjective assessments by the study physician. All data will be reported per instrument and a total score will be tabulated for a portion of the analysis.
Same as current
Not Provided
Not Provided
 
Effects of Exercise Training on Fluid Instability in Heart Failure Patients
Effects of Exercise Training on Fluid Instability in Heart Failure Patients

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure
Other: Exercise
Walking Strength Training Bicycling
  • Experimental: Arm 1
    Exercise
    Intervention: Other: Exercise
  • No Intervention: Arm 2
    Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
December 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Advanced Heart Failure
  • Ability to Walk
  • Over 21

Exclusion Criteria:

  • Renal Failure
  • Inability to walk
  • Physician exclusion
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01375673
NRI 09-228
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Andrea M Boyd, PhD Wm. Jennings Bryan Dorn VA Medical Center, Columbia SC
Department of Veterans Affairs
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP