Effects of Exercise Training on Fluid Instability in Heart Failure Patients
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Exercise Exercise: Walking Strength Training Bicycling |
Other: Exercise
Walking Strength Training Bicycling
|
No Intervention: Usual Care Usual Care |
Outcome Measures
Primary Outcome Measures
- Bioelectrical Impedance Change [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.
Secondary Outcome Measures
- Body Weight Change [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.
- Health Outcome Measures Change [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Advanced Heart Failure
-
Ability to Walk
-
Over 21
Exclusion Criteria:
-
Renal Failure
-
Inability to walk
-
Physician exclusion
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC | Columbia | South Carolina | United States | 29209 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Andrea M Boyd, PhD, Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NRI 09-228
Study Results
Participant Flow
Recruitment Details | 98 subjects were screened. Of the 98, 15 were female, 21 meet both inclusion and exclusion criteria, and 16 began the enrollment process. Of those 16 subjects, 1 died prior to full consent, 1 choose not to enroll. |
---|---|
Pre-assignment Detail |
Arm/Group Title | Exercise | Standard of Care |
---|---|---|
Arm/Group Description | Exercise: Walking Strength Training Bicycling | Standard of care |
Period Title: Overall Study | ||
STARTED | 7 | 7 |
COMPLETED | 7 | 6 |
NOT COMPLETED | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Exercise | Standard of Care | Total |
---|---|---|---|
Arm/Group Description | Exercise: Walking Strength Training Bicycling | Standard of Care | Total of all reporting groups |
Overall Participants | 7 | 7 | 14 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
7
100%
|
7
100%
|
14
100%
|
>=65 years |
0
0%
|
0
0%
|
0
0%
|
Sex: Female, Male (Count of Participants) | |||
Female |
0
0%
|
0
0%
|
0
0%
|
Male |
7
100%
|
7
100%
|
14
100%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
1
14.3%
|
0
0%
|
1
7.1%
|
Not Hispanic or Latino |
6
85.7%
|
7
100%
|
13
92.9%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
4
57.1%
|
3
42.9%
|
7
50%
|
White |
3
42.9%
|
4
57.1%
|
7
50%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (Count of Participants) | |||
United States |
7
100%
|
7
100%
|
14
100%
|
Ejection Fraction (Count of Participants) | |||
25% and less EF |
3
42.9%
|
3
42.9%
|
6
42.9%
|
26-40% EF |
2
28.6%
|
3
42.9%
|
5
35.7%
|
41% and greater EF |
2
28.6%
|
1
14.3%
|
3
21.4%
|
Outcome Measures
Title | Bioelectrical Impedance Change |
---|---|
Description | The extracellular fluid was calculated and reported to demonstrate Fluid Instability. A Bioelectrical Impedance Monitor was utilized to attain these measures. |
Time Frame | baseline, week 16, week 24 |
Outcome Measure Data
Analysis Population Description |
---|
BioImpedence/Extracellular vs intracellular fluid analyzed daily for 24 weeks. Daily values compressed into mean for week x 24 weeks. |
Arm/Group Title | Exercise | Standard of Care |
---|---|---|
Arm/Group Description | Exercise: Walking Strength Training Bicycling | Standard of Care |
Measure Participants | 7 | 7 |
Baseline-Week 4 |
47.52
(1.5)
|
47.1
(1.35)
|
Intervention-Week 16 |
41.27
(2)
|
46.8
(1.45)
|
Maintenance-Week 24 |
42.1
(1.7)
|
47.0
(1.4)
|
Title | Body Weight Change |
---|---|
Description | 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. |
Time Frame | baseline, week 16, week 24 |
Outcome Measure Data
Analysis Population Description |
---|
Daily weight was recorded in pounds and then converted into a weekly standard deviation |
Arm/Group Title | Exercise | Standard of Care |
---|---|---|
Arm/Group Description | Exercise: Walking Strength Training Bicycling | Standard of Care |
Measure Participants | 7 | 7 |
Baselline-Weeks 1-4 |
249
(2.14)
|
256
(1.88)
|
Intervention-Weeks 5-16 |
242
(0.45)
|
260
(1.9)
|
Maintenance-Weeks 17-24 |
258
(0.95)
|
261
(1.85)
|
Title | Health Outcome Measures Change |
---|---|
Description | 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. |
Time Frame | baseline, week 16, week 24 |
Outcome Measure Data
Analysis Population Description |
---|
The Heart Failure Questionnaire was assessed as a daily measure with weekly mean and SD being reported for each phase. The Likert Scale was converted to a continuous scale from 0 to 15 cm and scores added together for the 10 questions to get a total score. |
Arm/Group Title | Exercise | Standard of Care |
---|---|---|
Arm/Group Description | Exercise: Walking Strength Training Bicycling | Standard of Care |
Measure Participants | 7 | 7 |
Baseline-Week 4 |
25.05
(1.48)
|
27.25
(1.52)
|
Intervention-Week 16 |
18.2
(1.7)
|
28.25
(1.75)
|
Maintenance-Week 24 |
28.55
(3)
|
29.5
(1.8)
|
Adverse Events
Time Frame | 2 years | |||
---|---|---|---|---|
Adverse Event Reporting Description | No difference in definition | |||
Arm/Group Title | Exercise | Standard of Care | ||
Arm/Group Description | Exercise: Walking Strength Training Bicycling | Standard of Care | ||
All Cause Mortality |
||||
Exercise | Standard of Care | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/7 (0%) | 0/7 (0%) | ||
Serious Adverse Events |
||||
Exercise | Standard of Care | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/7 (0%) | 0/7 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Exercise | Standard of Care | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/7 (0%) | 0/7 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Andrea M. Boyd, PhD, Asscoaite Nurse Executive, Research/Education |
---|---|
Organization | WJB Dorn VAMC (VHA) |
Phone | 803.776.4000 ext 5654 |
andrea.boyd@va.gov |
- NRI 09-228