Trial Outcomes & Findings for Exercise Trial in Chronic Kidney Disease (NCT NCT01462097)
NCT ID: NCT01462097
Last Updated: 2023-01-25
Results Overview
VO2peak, measured by Graded Exercise Treadmill Test (GXT) with a modified Balke protocol - higher indicates better aerobic capacity
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
Baseline, 6 months, 12 months
Results posted on
2023-01-25
Participant Flow
March 2012 through June 2016 recruited from the University of Maryland Medical Center, VA Maryland Healthcare System, Tufts Medical Center, and Partners Healthcare.
Participant milestones
| Measure |
Aerobic Exercise
12 months of treadmill walking and strength training exercise. Exercise is gradually progressed in walking speed and time on the treadmill based on the individual's tolerance, abilities, and safety. For months 1-6 exercise will take place 3 times per week at the research center. For months 6-12 exercise will take place 2 times per week at the center and 1 time per week at home.
Aerobic exercise training: 12 months of aerobic exercise
|
Health Education
12 months of Health education sessions which will cover topics important to older adults (safe travel, age-appropriate preventative screenings, resources for reliable health information, and topics relevant to chronic kidney disease). For months 1-6 classes will take place 1 time per week. For months 6-12 classes will take place 1 time per month.
Health Education: 12 months of health education sessions
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
50
|
|
Overall Study
6 Month
|
35
|
37
|
|
Overall Study
COMPLETED
|
30
|
38
|
|
Overall Study
NOT COMPLETED
|
19
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exercise Trial in Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Aerobic Exercise
n=49 Participants
12 months of treadmill walking and strength training exercise. Exercise is gradually progressed in walking speed and time on the treadmill based on the individual's tolerance, abilities, and safety. For months 1-6 exercise will take place 3 times per week at the research center. For months 6-12 exercise will take place 2 times per week at the center and 1 time per week at home.
Aerobic exercise training: 12 months of aerobic exercise
|
Health Education
n=50 Participants
12 months of Health education sessions which will cover topics important to older adults (safe travel, age-appropriate preventative screenings, resources for reliable health information, and topics relevant to chronic kidney disease). For months 1-6 classes will take place 1 time per week. For months 6-12 classes will take place 1 time per month.
Health Education: 12 months of health education sessions
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
68.1 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
68.0 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
27 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
50 participants
n=7 Participants
|
99 participants
n=5 Participants
|
|
Estimated glomerular filtration rate (eGFR)
|
34.1 ml/min/1.73m^2
STANDARD_DEVIATION 9.5 • n=5 Participants
|
32.6 ml/min/1.73m^2
STANDARD_DEVIATION 11.4 • n=7 Participants
|
33.3 ml/min/1.73m^2
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Hemoglobin (g/dl)
|
12.5 g/dL
STANDARD_DEVIATION 1.6 • n=5 Participants
|
12.3 g/dL
STANDARD_DEVIATION 1.7 • n=7 Participants
|
12.4 g/dL
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Body Mass Index (kg/m2)
|
30.3 kg/m2
STANDARD_DEVIATION 7.2 • n=5 Participants
|
31.8 kg/m2
STANDARD_DEVIATION 5.8 • n=7 Participants
|
31.1 kg/m2
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Self-reported Moderate-vigorous physical activity
|
72 minutes/week
STANDARD_DEVIATION 126 • n=5 Participants
|
90 minutes/week
STANDARD_DEVIATION 174 • n=7 Participants
|
78 minutes/week
STANDARD_DEVIATION 150 • n=5 Participants
|
|
Coronary Artery Disease
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Diabetes
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Hypertension
|
44 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Heart Failure
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Peripheral vascular disease
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Chronic Obstructive Pulmonary Disease (COPD)
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Study Site
Tufts
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Study Site
Univ Maryland
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Participants with complete V02peak at \>=1 time point
VO2peak, measured by Graded Exercise Treadmill Test (GXT) with a modified Balke protocol - higher indicates better aerobic capacity
Outcome measures
| Measure |
Aerobic Exercise
n=48 Participants
12 months of treadmill walking and strength training exercise. Exercise is gradually progressed in walking speed and time on the treadmill based on the individual's tolerance, abilities, and safety. For months 1-6 exercise will take place 3 times per week at the research center. For months 6-12 exercise will take place 2 times per week at the center and 1 time per week at home.
Aerobic exercise training: 12 months of aerobic exercise
|
Health Education
n=50 Participants
12 months of Health education sessions which will cover topics important to older adults (safe travel, age-appropriate preventative screenings, resources for reliable health information, and topics relevant to chronic kidney disease). For months 1-6 classes will take place 1 time per week. For months 6-12 classes will take place 1 time per month.
Health Education: 12 months of health education sessions
|
|---|---|---|
|
Change in Peak Aerobic Capacity
Baseline
|
17.1 ml/kg/min
Standard Deviation 5.3
|
16.8 ml/kg/min
Standard Deviation 5.6
|
|
Change in Peak Aerobic Capacity
6 months
|
17.9 ml/kg/min
Standard Deviation 5.5
|
15.9 ml/kg/min
Standard Deviation 7.0
|
|
Change in Peak Aerobic Capacity
12 Months
|
18.7 ml/kg/min
Standard Deviation 5.2
|
17.2 ml/kg/min
Standard Deviation 6.4
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Total # with at least one measurement
Distance walked in 6 minutes - greater distance represents higher function
Outcome measures
| Measure |
Aerobic Exercise
n=49 Participants
12 months of treadmill walking and strength training exercise. Exercise is gradually progressed in walking speed and time on the treadmill based on the individual's tolerance, abilities, and safety. For months 1-6 exercise will take place 3 times per week at the research center. For months 6-12 exercise will take place 2 times per week at the center and 1 time per week at home.
Aerobic exercise training: 12 months of aerobic exercise
|
Health Education
n=50 Participants
12 months of Health education sessions which will cover topics important to older adults (safe travel, age-appropriate preventative screenings, resources for reliable health information, and topics relevant to chronic kidney disease). For months 1-6 classes will take place 1 time per week. For months 6-12 classes will take place 1 time per month.
Health Education: 12 months of health education sessions
|
|---|---|---|
|
Change in 6 Minute Walk
Baseline
|
1298 Feet
Standard Deviation 323
|
1251 Feet
Standard Deviation 394
|
|
Change in 6 Minute Walk
6 months
|
1649 Feet
Standard Deviation 620
|
1247 Feet
Standard Deviation 454
|
|
Change in 6 Minute Walk
12 months
|
1453 Feet
Standard Deviation 368
|
1284 Feet
Standard Deviation 462
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: \# of participants with complete measures
Timed Up and Go Test
Outcome measures
| Measure |
Aerobic Exercise
n=49 Participants
12 months of treadmill walking and strength training exercise. Exercise is gradually progressed in walking speed and time on the treadmill based on the individual's tolerance, abilities, and safety. For months 1-6 exercise will take place 3 times per week at the research center. For months 6-12 exercise will take place 2 times per week at the center and 1 time per week at home.
Aerobic exercise training: 12 months of aerobic exercise
|
Health Education
n=49 Participants
12 months of Health education sessions which will cover topics important to older adults (safe travel, age-appropriate preventative screenings, resources for reliable health information, and topics relevant to chronic kidney disease). For months 1-6 classes will take place 1 time per week. For months 6-12 classes will take place 1 time per month.
Health Education: 12 months of health education sessions
|
|---|---|---|
|
Change in Physical Function
Baseline
|
8.2 Seconds
Standard Deviation 2.4
|
8.6 Seconds
Standard Deviation 2.7
|
|
Change in Physical Function
6 months
|
8.0 Seconds
Standard Deviation 2.6
|
9.3 Seconds
Standard Deviation 3.6
|
|
Change in Physical Function
12 months
|
8.3 Seconds
Standard Deviation 29
|
9.0 Seconds
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: \# of participants with complete measures
Short Physical Performance Battery is a test of lower extremity function designed to be administered in older adults, consisting of three components: 1) usual gait speed over a 4-meter course; 2) five repeated chair stands; 3) standing balance battery. Each component is scored 0-4, with higher scores indicating better function, and the total scores of each component are summed (range, 0-12).
Outcome measures
| Measure |
Aerobic Exercise
n=49 Participants
12 months of treadmill walking and strength training exercise. Exercise is gradually progressed in walking speed and time on the treadmill based on the individual's tolerance, abilities, and safety. For months 1-6 exercise will take place 3 times per week at the research center. For months 6-12 exercise will take place 2 times per week at the center and 1 time per week at home.
Aerobic exercise training: 12 months of aerobic exercise
|
Health Education
n=50 Participants
12 months of Health education sessions which will cover topics important to older adults (safe travel, age-appropriate preventative screenings, resources for reliable health information, and topics relevant to chronic kidney disease). For months 1-6 classes will take place 1 time per week. For months 6-12 classes will take place 1 time per month.
Health Education: 12 months of health education sessions
|
|---|---|---|
|
Number With Short Physical Performance Battery (SPPB) Score <10 (Out of 12 Maximum)
Baseline
|
19 Participants
|
19 Participants
|
|
Number With Short Physical Performance Battery (SPPB) Score <10 (Out of 12 Maximum)
6 months
|
9 Participants
|
15 Participants
|
|
Number With Short Physical Performance Battery (SPPB) Score <10 (Out of 12 Maximum)
12 months
|
9 Participants
|
16 Participants
|
Adverse Events
Aerobic Exercise
Serious events: 21 serious events
Other events: 30 other events
Deaths: 1 deaths
Health Education
Serious events: 34 serious events
Other events: 31 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Aerobic Exercise
n=49 participants at risk
12 months of treadmill walking and strength training exercise. Exercise is gradually progressed in walking speed and time on the treadmill based on the individual's tolerance, abilities, and safety. For months 1-6 exercise will take place 3 times per week at the research center. For months 6-12 exercise will take place 2 times per week at the center and 1 time per week at home.
Aerobic exercise training: 12 months of aerobic exercise
|
Health Education
n=50 participants at risk
12 months of Health education sessions which will cover topics important to older adults (safe travel, age-appropriate preventative screenings, resources for reliable health information, and topics relevant to chronic kidney disease). For months 1-6 classes will take place 1 time per week. For months 6-12 classes will take place 1 time per month.
Health Education: 12 months of health education sessions
|
|---|---|---|
|
General disorders
All SAEs
|
42.9%
21/49 • Number of events 21 • 12 months or until loss to follow-up or withdrawal.
|
68.0%
34/50 • Number of events 34 • 12 months or until loss to follow-up or withdrawal.
|
Other adverse events
| Measure |
Aerobic Exercise
n=49 participants at risk
12 months of treadmill walking and strength training exercise. Exercise is gradually progressed in walking speed and time on the treadmill based on the individual's tolerance, abilities, and safety. For months 1-6 exercise will take place 3 times per week at the research center. For months 6-12 exercise will take place 2 times per week at the center and 1 time per week at home.
Aerobic exercise training: 12 months of aerobic exercise
|
Health Education
n=50 participants at risk
12 months of Health education sessions which will cover topics important to older adults (safe travel, age-appropriate preventative screenings, resources for reliable health information, and topics relevant to chronic kidney disease). For months 1-6 classes will take place 1 time per week. For months 6-12 classes will take place 1 time per month.
Health Education: 12 months of health education sessions
|
|---|---|---|
|
General disorders
All AEs
|
61.2%
30/49 • Number of events 66 • 12 months or until loss to follow-up or withdrawal.
|
62.0%
31/50 • Number of events 79 • 12 months or until loss to follow-up or withdrawal.
|
Additional Information
Stephen Seliger, MD MS
University of Maryland School of Medicine
Phone: 410-605-7000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place