Effects of Exercise Training on Fluid Instability in Heart Failure Patients

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT01375673
Collaborator
(none)
14
1
2
37
0.4

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
  • Other: Exercise
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

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Exercise Training on Fluid Instability in Heart Failure Patients
Study Start Date :
Nov 1, 2011
Actual Primary Completion Date :
Aug 1, 2014
Actual Study Completion Date :
Dec 1, 2014

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

  1. 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

  1. 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.

  2. 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

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01375673
Other Study ID Numbers:
  • NRI 09-228
First Posted:
Jun 17, 2011
Last Update Posted:
Jun 4, 2020
Last Verified:
May 1, 2020
Keywords provided by VA Office of Research and Development
Additional relevant MeSH terms:

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

1. Primary Outcome
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)
2. Secondary Outcome
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)
3. Secondary Outcome
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

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.

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
Email andrea.boyd@va.gov
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01375673
Other Study ID Numbers:
  • NRI 09-228
First Posted:
Jun 17, 2011
Last Update Posted:
Jun 4, 2020
Last Verified:
May 1, 2020