Effects of Exercise Training on Fluid Instability in Heart Failure Patients
1 other identifier
interventional
14
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Nov 2011
Typical duration for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2010
CompletedFirst Posted
Study publicly available on registry
June 17, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
June 4, 2020
CompletedJune 4, 2020
May 1, 2020
2.8 years
October 8, 2010
April 2, 2018
May 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bioelectrical Impedance Change
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 Outcomes (2)
Body Weight Change
baseline, week 16, week 24
Health Outcome Measures Change
baseline, week 16, week 24
Study Arms (2)
Exercise
EXPERIMENTALExercise: Walking Strength Training Bicycling
Usual Care
NO INTERVENTIONUsual Care
Interventions
Eligibility Criteria
You may qualify if:
- Advanced Heart Failure
- Ability to Walk
- Over 21
You may not qualify if:
- Renal Failure
- Inability to walk
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
Columbia, South Carolina, 29209, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Limited patient population due to the clinic, strict limitations of inclusion/exclusion criteria and the distance many participants would have had to travel to participate.
Results Point of Contact
- Title
- Andrea M. Boyd, PhD, Asscoaite Nurse Executive, Research/Education
- Organization
- WJB Dorn VAMC (VHA)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea M Boyd, PhD
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2010
First Posted
June 17, 2011
Study Start
November 1, 2011
Primary Completion
August 1, 2014
Study Completion
December 1, 2014
Last Updated
June 4, 2020
Results First Posted
June 4, 2020
Record last verified: 2020-05