Trial Outcomes & Findings for Effects of Exercise Training on Fluid Instability in Heart Failure Patients (NCT NCT01375673)

Last Updated: 2020-06-04

Results Overview

The extracellular fluid was calculated and reported to demonstrate Fluid Instability. A Bioelectrical Impedance Monitor was utilized to attain these measures.

Recruitment status

COMPLETED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

baseline, week 16, week 24

Results posted on

2020-06-04

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Exercise Exercise: Walking Strength Training Bicycling	Standard of Care Standard of care
Overall Study STARTED	7	7
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Exercise Exercise: Walking Strength Training Bicycling	Standard of Care Standard of care
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Effects of Exercise Training on Fluid Instability in Heart Failure Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exercise n=7 Participants Exercise: Walking Strength Training Bicycling	Standard of Care n=7 Participants Standard of Care	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Ejection Fraction 25% and less EF	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ejection Fraction 26-40% EF	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ejection Fraction 41% and greater EF	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, week 16, week 24

Population: BioImpedence/Extracellular vs intracellular fluid analyzed daily for 24 weeks. Daily values compressed into mean for week x 24 weeks.

The extracellular fluid was calculated and reported to demonstrate Fluid Instability. A Bioelectrical Impedance Monitor was utilized to attain these measures.

Outcome measures

Outcome measures
Measure	Exercise n=7 Participants Exercise: Walking Strength Training Bicycling	Standard of Care n=7 Participants Standard of Care
Bioelectrical Impedance Change Baseline-Week 4	47.52 Percentage of Extra Cellular Fluid Standard Deviation 1.5	47.1 Percentage of Extra Cellular Fluid Standard Deviation 1.35
Bioelectrical Impedance Change Intervention-Week 16	41.27 Percentage of Extra Cellular Fluid Standard Deviation 2	46.8 Percentage of Extra Cellular Fluid Standard Deviation 1.45
Bioelectrical Impedance Change Maintenance-Week 24	42.1 Percentage of Extra Cellular Fluid Standard Deviation 1.7	47.0 Percentage of Extra Cellular Fluid Standard Deviation 1.4

SECONDARY outcome

Timeframe: baseline, week 16, week 24

Population: Daily weight was recorded in pounds and then converted into a weekly standard deviation

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.

Outcome measures

Outcome measures
Measure	Exercise n=7 Participants Exercise: Walking Strength Training Bicycling	Standard of Care n=7 Participants Standard of Care
Body Weight Change Baselline-Weeks 1-4	249 Pounds Standard Deviation 2.14	256 Pounds Standard Deviation 1.88
Body Weight Change Intervention-Weeks 5-16	242 Pounds Standard Deviation 0.45	260 Pounds Standard Deviation 1.9
Body Weight Change Maintenance-Weeks 17-24	258 Pounds Standard Deviation 0.95	261 Pounds Standard Deviation 1.85

SECONDARY outcome

Timeframe: baseline, week 16, week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Exercise n=7 Participants Exercise: Walking Strength Training Bicycling	Standard of Care n=7 Participants Standard of Care
Health Outcome Measures Change Baseline-Week 4	25.05 Total Points Standard Deviation 1.48	27.25 Total Points Standard Deviation 1.52
Health Outcome Measures Change Intervention-Week 16	18.2 Total Points Standard Deviation 1.7	28.25 Total Points Standard Deviation 1.75
Health Outcome Measures Change Maintenance-Week 24	28.55 Total Points Standard Deviation 3	29.5 Total Points Standard Deviation 1.8

Adverse Events

Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrea M. Boyd, PhD, Asscoaite Nurse Executive, Research/Education

WJB Dorn VAMC (VHA)

Phone: 803.776.4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place