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
  Purpose

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.


Condition Intervention
Heart Failure
Other: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Exercise Training on Fluid Instability in Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Exercise
Other: Exercise
Walking Strength Training Bicycling
No Intervention: Arm 2
Usual Care

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced Heart Failure
  • Ability to Walk
  • Over 21

Exclusion Criteria:

  • Renal Failure
  • Inability to walk
  • Physician exclusion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375673

Locations
United States, South Carolina
Wm. Jennings Bryan Dorn VA Medical Center, Columbia SC
Columbia, South Carolina, United States, 29209
Sponsors and Collaborators
Investigators
Principal Investigator: Andrea M Boyd, PhD Wm. Jennings Bryan Dorn VA Medical Center, Columbia SC
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01375673     History of Changes
Other Study ID Numbers: NRI 09-228
Study First Received: October 8, 2010
Last Updated: May 13, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Exercise
Heart Failure
Mixed Effects Modeling

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014