Trial Outcomes & Findings for A Physical Activity Program in End-state Liver Disease (NCT NCT02776553)
NCT ID: NCT02776553
Last Updated: 2020-08-06
Results Overview
Peak VO2 will be obtained from cardiorespiratory stress test
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Change from Baseline to 12 weeks after baseline
Results posted on
2020-08-06
Participant Flow
227 Subjects were recruited from the UAMS liver transplant clinic. 207 were excluded for meeting exclusion criteria.
Participant milestones
| Measure |
Active (Physical Training Program)
physical activity + behavioral therapy + nutritional intervention
Nutritional consultation: Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids
Physical training program: Physical activity prescription will target ≥10,000 steps/day, taking into account all activities performed throughout the day, although the increment in activity should be no less than 3000 steps/day above the baseline.
Behavioral modification therapy: The behavior modification theory will be applied in the form of a structured set of cues and questions between investigator and participant at each visit in order to provide individually tailored counseling to enhance internal motivation and facilitate behavior change toward physical activity and dietary improvement that are adaptable to each participant's usual habits.
|
Control
nutritional intervention
Nutritional consultation: Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Active (Physical Training Program)
physical activity + behavioral therapy + nutritional intervention
Nutritional consultation: Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids
Physical training program: Physical activity prescription will target ≥10,000 steps/day, taking into account all activities performed throughout the day, although the increment in activity should be no less than 3000 steps/day above the baseline.
Behavioral modification therapy: The behavior modification theory will be applied in the form of a structured set of cues and questions between investigator and participant at each visit in order to provide individually tailored counseling to enhance internal motivation and facilitate behavior change toward physical activity and dietary improvement that are adaptable to each participant's usual habits.
|
Control
nutritional intervention
Nutritional consultation: Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
got liver transplant
|
1
|
2
|
|
Overall Study
had other surgery
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
A Physical Activity Program in End-state Liver Disease
Baseline characteristics by cohort
| Measure |
Active (Physical Training Program)
n=9 Participants
physical activity + behavioral therapy + nutritional intervention
Nutritional consultation: Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids
Physical training program: Physical activity prescription will target ≥10,000 steps/day, taking into account all activities performed throughout the day, although the increment in activity should be no less than 3000 steps/day above the baseline.
Behavioral modification therapy: The behavior modification theory will be applied in the form of a structured set of cues and questions between investigator and participant at each visit in order to provide individually tailored counseling to enhance internal motivation and facilitate behavior change toward physical activity and dietary improvement that are adaptable to each participant's usual habits.
|
Control
n=8 Participants
nutritional intervention
Nutritional consultation: Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 7 • n=99 Participants
|
54 years
STANDARD_DEVIATION 11 • n=107 Participants
|
55 years
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Etiology of cirrhosis-NASH/cryptogenic
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Etiology of cirrhosis-Hepatitis C
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Etiology of cirrhosis-Alcoholic
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Etiology of cirrhosis-Cholestatic
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Weight
|
92 kilograms
STANDARD_DEVIATION 21 • n=99 Participants
|
89 kilograms
STANDARD_DEVIATION 14 • n=107 Participants
|
91 kilograms
STANDARD_DEVIATION 18 • n=206 Participants
|
|
BMI
|
31 kg/m^2
STANDARD_DEVIATION 8 • n=99 Participants
|
29 kg/m^2
STANDARD_DEVIATION 4 • n=107 Participants
|
30 kg/m^2
STANDARD_DEVIATION 6 • n=206 Participants
|
|
Diabetes Mellitus
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Hypertension
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Use of beta-blocker
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Esophageal varices
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Prior variceal bleeding
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ascites
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Large volume paracentesis
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Hepatic encephalopathy
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Child-Turcotte-Pugh Score [median (range)]
|
9 units on a scale
n=99 Participants
|
10 units on a scale
n=107 Participants
|
9 units on a scale
n=206 Participants
|
|
Child-Turcotte-Pugh Class B
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Child-Turcotte-Pugh Class C
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
D'Amico Stage 4
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
D'Amico Stage 5
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Total bilirubin (mg/dL)
|
2.3 mg/dL
STANDARD_DEVIATION 1.3 • n=99 Participants
|
3.1 mg/dL
STANDARD_DEVIATION 1.5 • n=107 Participants
|
2.7 mg/dL
STANDARD_DEVIATION 1.4 • n=206 Participants
|
|
ALT
|
34 units per liter
STANDARD_DEVIATION 18 • n=99 Participants
|
45 units per liter
STANDARD_DEVIATION 16 • n=107 Participants
|
39 units per liter
STANDARD_DEVIATION 16 • n=206 Participants
|
|
AST
|
54 units per liter
STANDARD_DEVIATION 28 • n=99 Participants
|
78 units per liter
STANDARD_DEVIATION 31 • n=107 Participants
|
65 units per liter
STANDARD_DEVIATION 29 • n=206 Participants
|
|
Albumin
|
3.1 g/dL
STANDARD_DEVIATION 0.3 • n=99 Participants
|
2.5 g/dL
STANDARD_DEVIATION 0.6 • n=107 Participants
|
2.8 g/dL
STANDARD_DEVIATION 0.5 • n=206 Participants
|
|
Hemoglobin
|
12.1 g/dL
STANDARD_DEVIATION 2.6 • n=99 Participants
|
11.4 g/dL
STANDARD_DEVIATION 2.3 • n=107 Participants
|
11.7 g/dL
STANDARD_DEVIATION 2.4 • n=206 Participants
|
|
Platelets
|
121 thousand platelets/microliter
STANDARD_DEVIATION 74 • n=99 Participants
|
112 thousand platelets/microliter
STANDARD_DEVIATION 24 • n=107 Participants
|
116 thousand platelets/microliter
STANDARD_DEVIATION 63 • n=206 Participants
|
|
INR
|
1.4 units on a scale
STANDARD_DEVIATION 0.3 • n=99 Participants
|
1.7 units on a scale
STANDARD_DEVIATION 1.2 • n=107 Participants
|
1.5 units on a scale
STANDARD_DEVIATION 0.4 • n=206 Participants
|
|
Creatinine
|
0.8 mg/dL
STANDARD_DEVIATION 0.3 • n=99 Participants
|
0.9 mg/dL
STANDARD_DEVIATION 0.3 • n=107 Participants
|
0.9 mg/dL
STANDARD_DEVIATION 0.2 • n=206 Participants
|
|
Sodium
|
135 mEq/L
STANDARD_DEVIATION 3 • n=99 Participants
|
135 mEq/L
STANDARD_DEVIATION 4 • n=107 Participants
|
135 mEq/L
STANDARD_DEVIATION 3 • n=206 Participants
|
|
MELD-sodium
|
16 units on a scale
STANDARD_DEVIATION 4 • n=99 Participants
|
19 units on a scale
STANDARD_DEVIATION 3 • n=107 Participants
|
17 units on a scale
STANDARD_DEVIATION 4 • n=206 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to 12 weeks after baselinePeak VO2 will be obtained from cardiorespiratory stress test
Outcome measures
| Measure |
Active (Physical Training Program)
n=9 Participants
physical activity + behavioral therapy + nutritional intervention
Nutritional consultation: Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids
Physical training program: Physical activity prescription will target ≥10,000 steps/day, taking into account all activities performed throughout the day, although the increment in activity should be no less than 3000 steps/day above the baseline.
Behavioral modification therapy: The behavior modification theory will be applied in the form of a structured set of cues and questions between investigator and participant at each visit in order to provide individually tailored counseling to enhance internal motivation and facilitate behavior change toward physical activity and dietary improvement that are adaptable to each participant's usual habits.
|
Control
n=8 Participants
nutritional intervention
Nutritional consultation: Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids
|
|---|---|---|
|
Physical Fitness - VO2
|
-1 mL oxygen/kg/min
Standard Deviation 6.5
|
-3 mL oxygen/kg/min
Standard Deviation 6.5
|
PRIMARY outcome
Timeframe: Change from Baseline to 12 weeks after baselineTotal distance walked during 6-minute walk test
Outcome measures
| Measure |
Active (Physical Training Program)
n=6 Participants
physical activity + behavioral therapy + nutritional intervention
Nutritional consultation: Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids
Physical training program: Physical activity prescription will target ≥10,000 steps/day, taking into account all activities performed throughout the day, although the increment in activity should be no less than 3000 steps/day above the baseline.
Behavioral modification therapy: The behavior modification theory will be applied in the form of a structured set of cues and questions between investigator and participant at each visit in order to provide individually tailored counseling to enhance internal motivation and facilitate behavior change toward physical activity and dietary improvement that are adaptable to each participant's usual habits.
|
Control
n=5 Participants
nutritional intervention
Nutritional consultation: Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids
|
|---|---|---|
|
Physical Fitness - Distance Walked
|
59.2 meters
Interval -36.0 to 133.0
|
-91.4 meters
Interval -291.0 to 27.0
|
PRIMARY outcome
Timeframe: Change from Baseline to 12 weeks after baselineTotal thigh muscle volume (cm\^3), as determined by CT-scan.
Outcome measures
| Measure |
Active (Physical Training Program)
n=9 Participants
physical activity + behavioral therapy + nutritional intervention
Nutritional consultation: Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids
Physical training program: Physical activity prescription will target ≥10,000 steps/day, taking into account all activities performed throughout the day, although the increment in activity should be no less than 3000 steps/day above the baseline.
Behavioral modification therapy: The behavior modification theory will be applied in the form of a structured set of cues and questions between investigator and participant at each visit in order to provide individually tailored counseling to enhance internal motivation and facilitate behavior change toward physical activity and dietary improvement that are adaptable to each participant's usual habits.
|
Control
n=8 Participants
nutritional intervention
Nutritional consultation: Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids
|
|---|---|---|
|
Sarcopenia
|
-124 cubic centimeters
Interval -881.0 to 384.0
|
-373 cubic centimeters
Interval -881.0 to 384.0
|
Adverse Events
Active (Physical Training Program)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Arny A. Ferrando, Ph.D.
University of Arkansas for Medical Sciences
Phone: 501-526-5711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place