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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG022849 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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Chronic kidney disease (CKD), affects over 45% of all individuals over 70 years of age. Patients with moderate CKD have more than a two-fold increased risk of cognitive impairment than those without CKD; furthermore, as many as 20-70% of patients with CKD have established cognitive impairment and overt dementia. The burden of cognitive impairment and dementia leads to functional decline and accelerated loss of independence, contributing to the tremendous individual, societal, and economic burden of CKD (i.e., 20% of Medicare expenditures in adults >65 years of age). There is no recommended treatment to prevent cognitive decline in CKD patients, and the few medications available for cognitive impairment have only short term modest effects. There is a critical need to evaluate therapies to forestall cognitive impairment, and maintain or improve cognitive functioning in older patients with CKD. To address this need, this study will test the hypothesis that older patients with moderate/severe CKD and pre-clinical cognitive impairment randomized to a 6-month home-based exercise program will improve cognitive function and MRI measured brain structure, compared to a usual care control group. This study will combine an assessment of cognition with MR imaging techniques to fully evaluate brain structure, blood flow, and behavior relationships at a level previously not conducted in this population
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-based walking exercise | Experimental | 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. |
|
| Control | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partially supervised home-based walking exercise | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Global Cognitive Function | 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. | Change from baseline in composite global cognitive function at 6 months |
| Composite Executive Function | A 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. | Change from baseline in composite executive function at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| White Matter Integrity | 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. | Change from baseline white matter integrity fractional anisotropy at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
• current/past diagnosis of neurological/psychiatric disorders;
any medications to improve cognition or mood;
Diagnosed Dementia or a score of <2 on the mini-cog assessment
Ischemic ulcerations or gangrene on the feet or legs;
Participating in a supervised exercise program with intent to increase fitness levels 3 days/week,
Requires assistive ambulation;
Limited exercise capacity due to conditions other than claudication
Resting systolic BP >200 mmHg or resting diastolic BP >110 mmHg;
Revascularization procedures within the previous 6 months;
Any unforeseen illness or disability that would preclude exercise testing or training based on patient provider opinion;
Pregnancy
No diagnosis of CKD
One or more contraindication for MRI
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| Name | Affiliation | Role |
|---|---|---|
| Ulf G Bronas, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34570042 | Derived | Bronas UG, Hannan M, Lash JP, Ajilore O, Zhou XJ, Lamar M. Exercise Training and Cognitive Function in Kidney Disease: Protocol for a Pilot Randomized Controlled Trial. Nurs Res. 2022 Jan-Feb 01;71(1):75-82. doi: 10.1097/NNR.0000000000000554. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Composite Global Cognitive Function | 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. | Posted | Mean | Standard Deviation | Z-score | Change from baseline in composite global cognitive function at 6 months |
|
6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient ischemic attack | Vascular disorders | Non-systematic Assessment | An intervention participant was diagnosed with a transient ischemic attack (TIA). It was determined that this event was unrelated to study procedures and that no protocol revisions were required. The participant was discontinued from the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ulf Bronas | University of Illinois at Chicago | 312-355-5886 | bronas@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2018 | Jan 6, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007674 | Kidney Diseases |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Randomized, controlled design with a 1:1 allocation
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|
| Control | Behavioral | 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 | 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. | Change from baseline hippocampal volume at 6 months. |
| Cerebral Blood Flow | 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. | Change from baseline in cerebral blood flow at 6 months. |
| Vascular Health - Young's Elastic Modulus | 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. | Change from baseline in vascular health indices at 6 months |
| Cognitive Function - Total Cognition | 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 | Mean change from baseline to 6 months. |
| Motor Function - Grip Strength | 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. | Change from baseline in NIH toolbox motor function indices at 6 months |
| Vascular Health - Pulse Wave Velocity | 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. | 6 Months |
| Vascular Health - Augmentation Index | 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. | 6 Months |
| Cognitive Function - Fluid Cognition | 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. | Mean change from baseline to 6 months. |
| Cognitive Function - Crystalized Cognition | 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. | Mean change from baseline to 6 months. |
| Motor Function - Balance | 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. | 6 Months |
| Motor Function - Dexterity | 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. | 6 Months |
| Resting Global Connectivity | 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) | Change from baseline at 6 months |
| Hippocampal Volume - Left | 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. | Change from baseline at 6 Months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Primary | Composite Executive Function | A 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. | Posted | Mean | Standard Deviation | Z score | Change from baseline in composite executive function at 6 months |
|
|
|
| Secondary | White Matter Integrity | 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. | 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). | Posted | Mean | Standard Deviation | units on a scale | Change from baseline white matter integrity fractional anisotropy at 6 months |
|
|
|
| Secondary | Hippocampal Volume - Right | 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. | 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). | Posted | Mean | Standard Deviation | Cubic millimeters | Change from baseline hippocampal volume at 6 months. |
|
|
|
| Secondary | Cerebral Blood Flow | 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. | 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). | Posted | Mean | Standard Deviation | mL/100gm/min | Change from baseline in cerebral blood flow at 6 months. |
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| Secondary | Vascular Health - Young's Elastic Modulus | 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. | 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). | Posted | Mean | Standard Deviation | Kilo pascals | Change from baseline in vascular health indices at 6 months |
|
|
|
| Secondary | Cognitive Function - Total Cognition | 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 | 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). | Posted | Mean | Standard Deviation | Score on a scale | Mean change from baseline to 6 months. |
|
|
|
| Secondary | Motor Function - Grip Strength | 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. | 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). | Posted | Mean | Standard Deviation | Score on a scale | Change from baseline in NIH toolbox motor function indices at 6 months |
|
|
|
| Secondary | Vascular Health - Pulse Wave Velocity | 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. | 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). | Posted | Mean | Standard Deviation | Meters per second | 6 Months |
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|
| Secondary | Vascular Health - Augmentation Index | 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. | 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). | Posted | Mean | Standard Deviation | Percentage | 6 Months |
|
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| Secondary | Cognitive Function - Fluid Cognition | 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. | 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). | Posted | Mean | Standard Deviation | Score on a scale | Mean change from baseline to 6 months. |
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| Secondary | Cognitive Function - Crystalized Cognition | 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. | 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). | Posted | Mean | Standard Deviation | Score on a scale | Mean change from baseline to 6 months. |
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| Secondary | Motor Function - Balance | 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. | 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). | Posted | Mean | Standard Deviation | Score on a scale | 6 Months |
|
|
|
| Secondary | Motor Function - Dexterity | 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. | 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). | Posted | Mean | Standard Deviation | Score on a scale | 6 Months |
|
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| Secondary | Resting Global Connectivity | 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) | 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). | Posted | Mean | Standard Deviation | Z-score | Change from baseline at 6 months |
|
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|
| Secondary | Hippocampal Volume - Left | 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. | 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). | Posted | Mean | Standard Deviation | Cubic millimeters | Change from baseline at 6 Months |
|
|
|
| 0 |
| 22 |
| 1 |
| 22 |
| 14 |
| 22 |
| EG001 | 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. | 0 | 17 | 0 | 17 | 10 | 17 |
|
| ED visit: non-serious illness | General disorders | Systematic Assessment |
|
| ED visit: non-specific chest pain | Cardiac disorders | Systematic Assessment |
|
| ED visit - fall with head injury | Musculoskeletal and connective tissue disorders | Systematic Assessment | Participant fell out of bed at home. Unrelated to study participation. |
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| ED visit - blood pressure | Cardiac disorders | Systematic Assessment |
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| Dental surgery | Surgical and medical procedures | Systematic Assessment |
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| Home repair accident | Musculoskeletal and connective tissue disorders | Systematic Assessment | Drywall well on participant. |
|
| Urgent care visit: Calf pain, possible DVT | Vascular disorders | Systematic Assessment |
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| ED visit: feeling of weakness | Blood and lymphatic system disorders | Systematic Assessment | Possible anemia |
|
| Prostate and hernia surgery | Surgical and medical procedures | Systematic Assessment |
|
| Low ejection fraction | Cardiac disorders | Systematic Assessment |
|
| Calf muscle soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |