Cognitive Function, PreclinicalNCT03197038
Exercise Training and Cognitive Function in Kidney Disease
A study testing Partially supervised home-based walking exercise in people with Cognitive Function, Preclinical and Chronic Kidney Diseases, run by University of Illinois at Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function, Preclinical, Chronic Kidney Diseases, Older Adults
- What is being tested?
- Partially supervised home-based walking exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 18 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking men and women
- diagnosed stage 3-5 CKD (eGFR<60 to 15 ml/min);
- 60-80 years of age,
- self-experienced persistent decline in cognitive capacity determined as self-reported cognitive complaint (i.e., answering "yes" to the question: "Do you feel like your memory or thinking skills have gotten worse recently?" (before any clinical impairment of cognition has occurred)
- ability to undergo an MRI;
- no history of major head trauma.
Who cannot join
- • 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;
Show all 33Show fewer
- Limited exercise capacity due to conditions other than claudication
- unstable angina,
- Claudication
- severe arthritis,
- extreme dyspnea on exertion,
- unstable coronary artery disease;
- Class III-IV heart failure;
- Current uncontrolled sustained arrhythmias,
- severe/symptomatic aortic or mitral stenosis,
- hypertrophic obstructive cardiomyopathy,
- severe pulmonary hypertension,
- active myocarditis/pericarditis,
- thrombophlebitis,
- recent systemic/pulmonary embolus (within 3 months);
- 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
- cardiac pacemaker,
- aneurysm clip,
- cochlear implants,
- shrapnel,
- history of metal fragments in eyes,
- neurostimulators,
- diagnosed claustrophobia.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
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
- Being tested
- Partially supervised home-based walking exercise, Control
- Keywords
- Cognitive function, Kidney Disease, Exercise, Older adults
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partially supervised home-based walking exerciseBehavioural
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.
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Partially supervised home-based walking exercise |
| 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline in composite executive function at 6 months
Secondary outcomes (14)
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.
Measured: Change from baseline white matter integrity fractional anisotropy at 6 months
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: Change from baseline at 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start1 Sep 2017
- Primary completion26 Nov 2019
- Study completion18 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive Function, PreclinicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled design with a 1:1 allocation
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Ulf G. Bronas, University of Illinois at Chicago
- Investigators
- Ulf G Bronas, PhD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197038
- Sponsor's protocol ID
- 2016-1217
- Other IDs
- P30AG022849
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2017
- Last updated
- 2 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34570042
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training and Cognitive Function in Kidney Disease
- ClinicalTrials.gov ID
- NCT03197038
- Acronym / sponsor ID
- 2016-1217
- Keywords
- Cognitive function, Kidney Disease, Exercise, Older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 23 Jun 2017 (actual)
- Results
- Posted 2 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled design with a 1:1 allocation
| Arm | Type | Receives |
|---|---|---|
| Home-based walking exercise | Experimental | Behavioral: Partially supervised home-based walking exerciseHome-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 | Behavioral: ControlThe 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- English speaking men and women
- diagnosed stage 3-5 CKD (eGFR<60 to 15 ml/min);
- 60-80 years of age,
- self-experienced persistent decline in cognitive capacity determined as self-reported cognitive complaint (i.e., answering "yes" to the question: "Do you feel like your memory or thinking skills have gotten worse recently?" (before any clinical impairment of cognition has occurred)
- ability to undergo an MRI;
Key exclusion criteria (33 listed)
- • current/past diagnosis of neurological/psychiatric disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partially supervised home-based walking exerciseParticipants 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. | Behavioural | Home-based walking exercise |
| ControlParticipants 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. | Behavioural | Control |
Primary outcome
Composite Global Cognitive Function
Time frame: Change from baseline in composite global cognitive function at 6 months
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.
Composite Executive Function
Time frame: Change from baseline in composite executive function at 6 months
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.
14 secondary outcomes
White Matter Integrity
Time frame: Change from baseline white matter integrity fractional anisotropy at 6 months
Hippocampal Volume - Right
Time frame: Change from baseline hippocampal volume at 6 months.
Cerebral Blood Flow
Time frame: Change from baseline in cerebral blood flow at 6 months.
Vascular Health - Young's Elastic Modulus
Time frame: Change from baseline in vascular health indices at 6 months
Cognitive Function - Total Cognition
Time frame: Mean change from baseline to 6 months.
Motor Function - Grip Strength
Time frame: Change from baseline in NIH toolbox motor function indices at 6 months
Vascular Health - Pulse Wave Velocity
Time frame: 6 Months
Vascular Health - Augmentation Index
Time frame: 6 Months
Cognitive Function - Fluid Cognition
Time frame: Mean change from baseline to 6 months.
Cognitive Function - Crystalized Cognition
Time frame: Mean change from baseline to 6 months.
Motor Function - Balance
Time frame: 6 Months
Motor Function - Dexterity
Time frame: 6 Months
Resting Global Connectivity
Time frame: Change from baseline at 6 months
Hippocampal Volume - Left
Time frame: Change from baseline at 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34570042Bronas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulf G Bronas, PhD principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partially supervised home-based walking exercise in people with Cognitive Function, Preclinical and Chronic Kidney Diseases, run by University of Illinois at Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Global Cognitive Function (time frame: Change from baseline in composite global cognitive function at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03197038, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.