N/A
N=39
Exercise Training and Cognitive Function in Kidney Disease
Cognitive Function, Preclinical · Chronic Kidney Diseases · Older Adults
Bottom Line
View on ClinicalTrials.gov: NCT03197038 ↗Enrolled (actual)
39
Serious AEs
2.6%
Results posted
Jul 2021
Primary outcome: Primary: Composite Global Cognitive Function — .15; .02 Z-score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Partially supervised home-based walking exercise (Behavioral); Control (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Global Cognitive Function |
.15; .02 | — |
| PRIMARY Composite Executive Function |
0.21; -.01 | — |
| SECONDARY White Matter Integrity |
-.002; .003 | — |
| SECONDARY Hippocampal Volume - Right |
.003; .003 | — |
| SECONDARY Cerebral Blood Flow |
1.6; 0.3 | — |
| SECONDARY Vascular Health - Young's Elastic Modulus |
-3,175; 1,279 | — |
| SECONDARY Cognitive Function - Total Cognition |
8; 11 | — |
| SECONDARY Motor Function - Grip Strength |
3; -2.5 | — |
| SECONDARY Vascular Health - Pulse Wave Velocity |
-.01; .21 | — |
| SECONDARY Vascular Health - Augmentation Index |
-2.6; 3.3 | — |
| SECONDARY Cognitive Function - Fluid Cognition |
5.2; 11 | — |
| SECONDARY Cognitive Function - Crystalized Cognition |
7.7; 8.3 | — |
| SECONDARY Motor Function - Balance |
-6; -8 | — |
| SECONDARY Motor Function - Dexterity |
1.2; 1.8 | — |
| SECONDARY Resting Global Connectivity |
.0047; -.0310 | — |
| SECONDARY Hippocampal Volume - Left |
-.0001; .0 | — |
Summary
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
Eligibility Criteria
Inclusion Criteria
- English speaking men and women
- diagnosed stage 3-5 CKD (eGFR 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
- cardiac pacemaker,
- aneurysm clip,
- cochlear implants,
- shrapnel,
- history of metal fragments in eyes,
- neurostimulators,
- diagnosed claustrophobia.
Data sourced from ClinicalTrials.gov (NCT03197038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.