Trial Outcomes & Findings for Exercise Training and Cognitive Function in Kidney Disease (NCT NCT03197038)
NCT ID: NCT03197038
Last Updated: 2021-07-02
Results Overview
Determine the effect of a 6-month home-based exercise program on composite global cognitive functioning as determined by principal component analysis of immediate free recall of trials 1-5 on California verbal learning II, long-delay free recall and recognition, and memory discriminability, trail making test part A and part B, digit symbol substitution test, semantic and phonemic fluency, and Digit span subtest in older patients with kidney disease and preclinical cognitive impairment. A composite global cognitive score was created by converting the individual cognitive scores to standardized z scores and then averaging the standardized z scores. An increase in change from baseline to 6 months is considered an improvement.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
Change from baseline in composite global cognitive function at 6 months
Results posted on
2021-07-02
Participant Flow
Participant milestones
| Measure |
Home-based Walking Exercise
Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.
Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.
|
Control
The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.
Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
17
|
|
Overall Study
COMPLETED
|
18
|
17
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exercise Training and Cognitive Function in Kidney Disease
Baseline characteristics by cohort
| Measure |
Home-based Walking Exercise
n=22 Participants
Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.
Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.
|
Control
n=17 Participants
The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.
Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.
|
Total
n=39 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
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Continuous
|
66.68 Years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
68.76 Years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
67.6 Years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 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
|
22 participants
n=5 Participants
|
17 participants
n=7 Participants
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline in composite global cognitive function at 6 monthsDetermine the effect of a 6-month home-based exercise program on composite global cognitive functioning as determined by principal component analysis of immediate free recall of trials 1-5 on California verbal learning II, long-delay free recall and recognition, and memory discriminability, trail making test part A and part B, digit symbol substitution test, semantic and phonemic fluency, and Digit span subtest in older patients with kidney disease and preclinical cognitive impairment. A composite global cognitive score was created by converting the individual cognitive scores to standardized z scores and then averaging the standardized z scores. An increase in change from baseline to 6 months is considered an improvement.
Outcome measures
| Measure |
Home-based Walking Exercise
n=18 Participants
Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.
Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.
|
Control
n=17 Participants
The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.
Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.
|
|---|---|---|
|
Composite Global Cognitive Function
|
.15 Z-score
Standard Deviation .37
|
.02 Z-score
Standard Deviation .33
|
PRIMARY outcome
Timeframe: Change from baseline in composite executive function at 6 monthsA composite executive functioning score was created by converting 4 individual executive cognitive scores (verbal fluency FAS and animal summary score, digit span backward subtest, and TMT-B) to standardized z scores and then averaging the standardized z scores. A larger change in Z score is considered an improvement.
Outcome measures
| Measure |
Home-based Walking Exercise
n=18 Participants
Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.
Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.
|
Control
n=17 Participants
The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.
Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.
|
|---|---|---|
|
Composite Executive Function
|
0.21 Z score
Standard Deviation .47
|
-.01 Z score
Standard Deviation .47
|
SECONDARY outcome
Timeframe: Change from baseline white matter integrity fractional anisotropy at 6 monthsPopulation: Of the total sample of 39 participants, 31 participants were able to undergo MRI scans. Of these, four participants did not complete the study. Good quality data, without motion distortion , were available in 25 participants (two participants were excluded due to motion distortion) at baseline and follow-up and were included in the analysis (11 intervention participants and 14 control participants).
Whole brain white matter integrity was created by averaging the fractional anisotropy of 80 tracts using region of interest analysis. An increased change from baseline to 6 months in fractional anisotropy (a measure of directionality, 0 = no principle direction, 1 = one principle direction) is considered an improvement.
Outcome measures
| Measure |
Home-based Walking Exercise
n=11 Participants
Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.
Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.
|
Control
n=14 Participants
The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.
Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.
|
|---|---|---|
|
White Matter Integrity
|
-.002 units on a scale
Standard Deviation .02
|
.003 units on a scale
Standard Deviation .01
|
SECONDARY outcome
Timeframe: Change from baseline hippocampal volume at 6 months.Population: Of the total sample of 39 participants, 31 participants were able to undergo MRI scans. Of these, four participants did not complete the study. Good quality data, without motion distortion, were available in 21 participants (four participants were excluded due to motion distortion) at baseline and follow-up and were included in the analysis (9 intervention participants and 12 control participants).
Determine the effect of a 6-month exercise program on hippocampal volume. An increased change from baseline to 6 months in right hippocampal volume in cubic millimeters is considered an improvement.
Outcome measures
| Measure |
Home-based Walking Exercise
n=9 Participants
Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.
Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.
|
Control
n=12 Participants
The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.
Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.
|
|---|---|---|
|
Hippocampal Volume - Right
|
.003 Cubic millimeters
Standard Deviation .0002
|
.003 Cubic millimeters
Standard Deviation .003
|
SECONDARY outcome
Timeframe: Change from baseline in cerebral blood flow at 6 months.Population: Of the total sample of 39 participants, 31 participants were able to undergo MRI scans. Of these, four participants did not complete the study. Good quality data, without motion distortion, were available in 25 participants (two participants were excluded due to motion distortion) at baseline and follow-up and were included in the analysis (11 intervention participants and 14 control participants).
Determine the effect of a 6-month exercise program on cerebral blood flow. Change in global cerebral blood measured in mL/100g/min from baseline to 6 months. An larger change is considered an improvement.
Outcome measures
| Measure |
Home-based Walking Exercise
n=11 Participants
Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.
Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.
|
Control
n=14 Participants
The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.
Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.
|
|---|---|---|
|
Cerebral Blood Flow
|
1.6 mL/100gm/min
Standard Deviation 9.8
|
0.3 mL/100gm/min
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: Change from baseline in vascular health indices at 6 monthsPopulation: Of the total sample of 39 participants, four participants did not complete the study. Good quality data, without motion distortion, were available in 33 participants (two participants were excluded due to motion distortion) at baseline and follow-up and were included in the analysis (17 intervention participants and 16 control participants).
Vascular health was assessed by Young's Elastic Modulus (YEM) at the carotid artery. A larger negative change in YEM (measured in kilo pascal, stiffer artery=higher number) from baseline to 6 months is considered an improvement.
Outcome measures
| Measure |
Home-based Walking Exercise
n=17 Participants
Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.
Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.
|
Control
n=16 Participants
The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.
Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.
|
|---|---|---|
|
Vascular Health - Young's Elastic Modulus
|
-3,175 Kilo pascals
Standard Deviation 9,428
|
1,279 Kilo pascals
Standard Deviation 8,654
|
SECONDARY outcome
Timeframe: Mean change from baseline to 6 months.Population: Data was collected in a sub-sample (n=12) to provide pilot data on the NIH-toolbox as part of an administrative supplement. Of the 12 participants that were part of the sub-sample, two did not complete the study. Baseline and follow-up data was available in 10 participants (6=intervention, 4=control).
Determine the effect of a 6-month exercise program on cognitive function via the NIH toolbox This composite includes: Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting and Pattern Comparison. This composite score is derived by averaging the standard scores of each of the measures, and then deriving standard scores based on this new distribution. An Age-Corrected Standard Score was used. Scale runs 140 to 23, a higher score means a better outcome. An increased change from baseline to 6 months is considered an improvement
Outcome measures
| Measure |
Home-based Walking Exercise
n=6 Participants
Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.
Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.
|
Control
n=4 Participants
The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.
Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.
|
|---|---|---|
|
Cognitive Function - Total Cognition
|
8 Score on a scale
Standard Deviation 7.4
|
11 Score on a scale
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: Change from baseline in NIH toolbox motor function indices at 6 monthsPopulation: Data was collected in a sub-sample (n=12) to provide pilot data on the NIH-toolbox as part of an administrative supplement. Of the 12 participants that were part of the sub-sample, two did not complete the study. Baseline and follow-up data was available in 10 participants (6=intervention, 4=control).
Determine the effect of a 6-month exercise program on motor function via the NIH toolbox. Age corrected grip strength on a standard scale. Standard scale 140-23, higher score is better. An increased change from baseline to 6 months is considered an improvement.
Outcome measures
| Measure |
Home-based Walking Exercise
n=6 Participants
Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.
Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.
|
Control
n=4 Participants
The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.
Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.
|
|---|---|---|
|
Motor Function - Grip Strength
|
3 Score on a scale
Standard Deviation 6.2
|
-2.5 Score on a scale
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Of the 39 participants that were enrolled, four did not complete the study. Good quality data without motion distortion at baseline and follow up was available in 30 participants (15=intervention, 15=control).
Vascular function indices of vascular health was assessed using pulse wave velocity of the aorta in meters/second (higher number =more stiff aorta). A larger negative change from baseline to 6 months is considered an improvement.
Outcome measures
| Measure |
Home-based Walking Exercise
n=15 Participants
Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.
Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.
|
Control
n=15 Participants
The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.
Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.
|
|---|---|---|
|
Vascular Health - Pulse Wave Velocity
|
-.01 Meters per second
Standard Deviation 1.1
|
.21 Meters per second
Standard Deviation .92
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Of the 39 participants enrolled, four did not complete the study. Good quality data without motion distortion at baseline and follow-up was available in 34 participants (18=intervention, 16=control).
Vascular function indices of vascular health was assessed using augmentation index at the carotid artery (in percentage, higher percent=more stiff artery). A larger negative change from baseline to 6 months is considered an improvement.
Outcome measures
| Measure |
Home-based Walking Exercise
n=18 Participants
Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.
Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.
|
Control
n=16 Participants
The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.
Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.
|
|---|---|---|
|
Vascular Health - Augmentation Index
|
-2.6 Percentage
Standard Deviation 12.1
|
3.3 Percentage
Standard Deviation 16.6
|
SECONDARY outcome
Timeframe: Mean change from baseline to 6 months.Population: Data was collected in a sub-sample (n=12) to provide pilot data on the NIH-toolbox as part of an administrative supplement. Of the 12 participants that were part of the sub-sample, two did not complete the study. Baseline and follow-up data was available in 10 participants (6=intervention, 4=control).
Determine the effect of a 6-month exercise program on cognitive function via the NIH toolbox. Fluid cognition. This composite includes: Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting and Pattern Comparison. This composite score is derived by averaging the standard scores of each of the measures, and then deriving standard scores based on this new distribution. An Age-Corrected Standard Score was used. A larger change from baseline to 6 months is considered an improvement. Scale runs 140 to 23, a higher score means a better outcome.
Outcome measures
| Measure |
Home-based Walking Exercise
n=6 Participants
Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.
Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.
|
Control
n=4 Participants
The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.
Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.
|
|---|---|---|
|
Cognitive Function - Fluid Cognition
|
5.2 Score on a scale
Standard Deviation 12.2
|
11 Score on a scale
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: Mean change from baseline to 6 months.Population: Data was collected in a sub-sample (n=12) to provide pilot data on the NIH-toolbox as part of an administrative supplement. Of the 12 participants that were part of the sub-sample, two did not complete the study. Baseline and follow-up data was available in 10 participants (6=intervention, 4=control).
Change from baseline in NIH toolbox cognitive function indices at 6 months. Crystalized cognition. This composite includes : Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting and Pattern Comparison. This composite score is derived by averaging the standard scores of each of the measures, and then deriving standard scores based on this new distribution. An Age-Corrected Standard Score was used. An larger change from baseline to 6 months is considered an improvement. Scale runs 140 to 23, a higher score means a better outcome.
Outcome measures
| Measure |
Home-based Walking Exercise
n=6 Participants
Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.
Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.
|
Control
n=4 Participants
The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.
Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.
|
|---|---|---|
|
Cognitive Function - Crystalized Cognition
|
7.7 Score on a scale
Standard Deviation 7.5
|
8.3 Score on a scale
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Data was collected in a sub-sample (n=12) to provide pilot data on the NIH-toolbox as part of an administrative supplement. Of the 12 participants that were part of the sub-sample, two did not complete the study. Baseline and follow-up data was available in 10 participants (6=intervention, 4=control).
Determine the effect of a 6-month exercise program on motor function via the NIH toolbox. Change in balance age corrected standard score from baseline to 6-months (23-140, higher score is better). A larger change is considered an improvement.
Outcome measures
| Measure |
Home-based Walking Exercise
n=6 Participants
Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.
Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.
|
Control
n=4 Participants
The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.
Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.
|
|---|---|---|
|
Motor Function - Balance
|
-6 Score on a scale
Standard Deviation 8.5
|
-8 Score on a scale
Standard Deviation 25
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Data was collected in a sub-sample (n=12) to provide pilot data on the NIH-toolbox as part of an administrative supplement. Of the 12 participants that were part of the sub-sample, two did not complete the study. Baseline and follow-up data was available in 10 participants (6=intervention, 4=control).
Determine the effect of a 6-month exercise program on motor function via the NIH toolbox. Hand dexterity was determine using age corrected standard scale in the dominant hand. A larger change from baseline to 6 months is considered an improvement. Standard scale range 140-23, higher score is better.
Outcome measures
| Measure |
Home-based Walking Exercise
n=6 Participants
Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.
Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.
|
Control
n=4 Participants
The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.
Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.
|
|---|---|---|
|
Motor Function - Dexterity
|
1.2 Score on a scale
Standard Deviation 4.5
|
1.8 Score on a scale
Standard Deviation 15.5
|
SECONDARY outcome
Timeframe: Change from baseline at 6 monthsPopulation: Resting global connectivity was collected in a sub-sample (n=12) to provide pilot data. Of the 12 participants that were part of the sub-sample, two did not complete the study. Good quality data without motion distortion at baseline and follow-up was available in 10 participants (5=intervention, 5=control).
Resting global connectivity measured and averaged across 132 regions. A larger change from baseline to 6 months is considered an improvement. Connectivity is a correlation (increased connectivity=higher correlation)
Outcome measures
| Measure |
Home-based Walking Exercise
n=5 Participants
Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.
Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.
|
Control
n=5 Participants
The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.
Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.
|
|---|---|---|
|
Resting Global Connectivity
|
.0047 Z-score
Standard Deviation .0356
|
-.0310 Z-score
Standard Deviation .019
|
SECONDARY outcome
Timeframe: Change from baseline at 6 MonthsPopulation: Of the total sample of 39 participants, 31 participants were able to undergo MRI scans. Of these, four participants did not complete the study. Good quality data, without motion distortion, were available in 21 participants (four participants were excluded due to motion distortion) at baseline and follow-up and were included in the analysis (9 intervention participants and 12 control participants).
Determine the effect of a 6-month exercise program on hippocampal volume. An larger change from baseline to 6 months in left hippocampal volume (cubic millimeters) is considered an improvement.
Outcome measures
| Measure |
Home-based Walking Exercise
n=9 Participants
Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.
Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.
|
Control
n=12 Participants
The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.
Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.
|
|---|---|---|
|
Hippocampal Volume - Left
|
-.0001 Cubic millimeters
Standard Deviation .0002
|
.0 Cubic millimeters
Standard Deviation .0001
|
Adverse Events
Home-based Walking Exercise
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Home-based Walking Exercise
n=22 participants at risk
Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.
Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.
|
Control
n=17 participants at risk
The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.
Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.
|
|---|---|---|
|
Vascular disorders
Transient ischemic attack
|
4.5%
1/22 • Number of events 1 • 6 months.
|
0.00%
0/17 • 6 months.
|
Other adverse events
| Measure |
Home-based Walking Exercise
n=22 participants at risk
Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.
Partially supervised home-based walking exercise: Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.
|
Control
n=17 participants at risk
The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.
Control: Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fall
|
0.00%
0/22 • 6 months.
|
11.8%
2/17 • Number of events 2 • 6 months.
|
|
General disorders
ED visit: non-serious illness
|
13.6%
3/22 • Number of events 3 • 6 months.
|
23.5%
4/17 • Number of events 4 • 6 months.
|
|
Cardiac disorders
ED visit: non-specific chest pain
|
4.5%
1/22 • Number of events 1 • 6 months.
|
23.5%
4/17 • Number of events 4 • 6 months.
|
|
Musculoskeletal and connective tissue disorders
ED visit - fall with head injury
|
4.5%
1/22 • Number of events 1 • 6 months.
|
0.00%
0/17 • 6 months.
|
|
Cardiac disorders
ED visit - blood pressure
|
4.5%
1/22 • Number of events 1 • 6 months.
|
0.00%
0/17 • 6 months.
|
|
Surgical and medical procedures
Dental surgery
|
4.5%
1/22 • Number of events 1 • 6 months.
|
0.00%
0/17 • 6 months.
|
|
Musculoskeletal and connective tissue disorders
Home repair accident
|
4.5%
1/22 • Number of events 1 • 6 months.
|
0.00%
0/17 • 6 months.
|
|
Vascular disorders
Urgent care visit: Calf pain, possible DVT
|
4.5%
1/22 • Number of events 1 • 6 months.
|
0.00%
0/17 • 6 months.
|
|
Blood and lymphatic system disorders
ED visit: feeling of weakness
|
4.5%
1/22 • Number of events 1 • 6 months.
|
0.00%
0/17 • 6 months.
|
|
Surgical and medical procedures
Prostate and hernia surgery
|
9.1%
2/22 • Number of events 2 • 6 months.
|
5.9%
1/17 • Number of events 1 • 6 months.
|
|
Cardiac disorders
Low ejection fraction
|
4.5%
1/22 • Number of events 1 • 6 months.
|
0.00%
0/17 • 6 months.
|
|
Musculoskeletal and connective tissue disorders
Calf muscle soreness
|
4.5%
1/22 • Number of events 1 • 6 months.
|
0.00%
0/17 • 6 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place