Cognitive ImpairmentNCT02145702
Impact of Exercise on Cognitive Impairment in End-Stage Renal Disease
A study testing Aerobic Exercise in people with Cognitive Impairment and End-Stage Renal Disease, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the impact of 12 weeks of exercise on cognition in patients with end stage renal disease. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cognitive Impairment, End-Stage Renal Disease
- What is being tested?
- Aerobic Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ESRD on dialysis
- Age greater than 20 years
- Have means of transportation to and from the exercise session
- Speak English (as the neuropsychological tests will be performed in English)
Who cannot join
- Recent myocardial infarction (within 6 weeks), unstable angina, uncontrolled arrhythmias, congestive heart failure (> NYHA grade II)
- History of stroke in the last 2 months
- Active respiratory disease
- Uncontrolled hypertension
- Severe uncontrolled diabetes
- Persistent predialysis hyperkalemia
Show all 14Show fewer
- Active decompensated liver disease
- Symptomatic peripheral vascular disease
- Musculoskeletal abnormalities that will be prohibit their participation in the exercise program
- Health conditions needing frequent hospitalizations
- Other health conditions causing inability to follow exercise program correctly
- Unwillingness to participate in structured exercise program
- Current use of antipsychotics or anti-epileptics
- Inability to hear, read or write which will limit their ability to perform the cognitive tests
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to evaluate the impact of 12 weeks of exercise on cognition in patients with end stage renal disease.
Read the detailed description
Patients with end stage renal disease have higher cognitive impairment than general population. They also have decreased physical and functional capacity. Exercise has shown to improve cognition in general population. This study will evaluate if exercise improves cognition in dialysis patients. It will also evaluate whether exercise affects performance in daily activities, mood or depression and inflammatory markers in the blood.
- Conditions
- Cognitive Impairment, End-Stage Renal Disease
- Being tested
- Aerobic Exercise, Standard Care Dialysis
- Keywords
- ESRD, Kidney Failure, Exercise, Cognitive impairment
- Medical subject headings
- Cognitive Dysfunction, Kidney Failure, Chronic, Renal Insufficiency, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
Each exercise session will be conducted at the KUMC Exercise and Cardiovascular Health (REACH) Laboratory. Exercise sessions will include a warm-up period, exercise period and a cool down period. Exercise intervention individualized based on health of participant. Subject will be asked to completed two exercise sessions per week for 12 weeks.
Standard Care DialysisProcedure or surgery
12 weeks of standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Subjects randomized to this group will start 12 weeks of supervised aerobic exercise after baseline testing. Receives: Other: Aerobic Exercise |
| Control Group | Experimental | Subjects randomized to this group will continue with 12 weeks of Standard Care. After 12 weeks, the subjects will cross over to the exercise arm and undergo baseline testing again and then start 12 weeks of exercise intervention. Receives: Other: Aerobic Exercise; Procedure: Standard Care Dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Subject compliance with exercise training
Measured: Up to 26 Weeks
Secondary outcomes (2)
Cognitive function
Measured using a standard battery of neuropsychological tests.
Measured: Baseline, within1 week before and within 1 week after exercise intervention
Markers of inflammation
Markers of inflammation will be evaluated before and after exercise intervention
Measured: Baseline, within 1 week before and within 1 week after exercise intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: Funding has expired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aditi Gupta, MD, University of Kansas Medical Center
- Investigators
- Aditi Gupta, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145702
- Sponsor's protocol ID
- STUDY00000284
- Status last verified
- Mar 2019
- First submitted
- 17 May 2014
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exercise on Cognitive Impairment in End-Stage Renal Disease
- ClinicalTrials.gov ID
- NCT02145702
- Acronym / sponsor ID
- STUDY00000284
- Conditions
- Cognitive Impairment, End-Stage Renal Disease
- Keywords
- ESRD, Kidney Failure, Exercise, Cognitive impairment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding has expired
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 23 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the impact of 12 weeks of exercise on cognition in patients with end stage renal disease.
Detailed description
Patients with end stage renal disease have higher cognitive impairment than general population. They also have decreased physical and functional capacity. Exercise has shown to improve cognition in general population. This study will evaluate if exercise improves cognition in dialysis patients. It will also evaluate whether exercise affects performance in daily activities, mood or depression and inflammatory markers in the blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Aerobic ExerciseSubjects randomized to this group will start 12 weeks of supervised aerobic exercise after baseline testing. |
| Control Group | Experimental | Other: Aerobic Exercise, Procedure: Standard Care DialysisSubjects randomized to this group will continue with 12 weeks of Standard Care. After 12 weeks, the subjects will cross over to the exercise arm and undergo baseline testing again and then start 12 weeks of exercise intervention. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with ESRD on dialysis
- Age greater than 20 years
- Have means of transportation to and from the exercise session
- Speak English (as the neuropsychological tests will be performed in English)
Key exclusion criteria (14 listed)
- Recent myocardial infarction (within 6 weeks), unstable angina, uncontrolled arrhythmias, congestive heart failure (> NYHA grade II)
- History of stroke in the last 2 months
- Active respiratory disease
- Uncontrolled hypertension
- Severe uncontrolled diabetes
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 |
|---|---|---|
| Aerobic ExerciseEach exercise session will be conducted at the KUMC Exercise and Cardiovascular Health (REACH) Laboratory. Exercise sessions will include a warm-up period, exercise period and a cool down period. Exercise intervention individualized based on health of participant. Subject will be asked to completed two exercise sessions per week for 12 weeks. | Other | Control Group, Exercise Group |
| Standard Care Dialysis12 weeks of standard of care. | Procedure or surgery | Control Group |
Primary outcome
Feasibility
Time frame: Up to 26 Weeks
Subject compliance with exercise training
2 secondary outcomes
Cognitive function
Time frame: Baseline, within1 week before and within 1 week after exercise intervention
Markers of inflammation
Time frame: Baseline, within 1 week before and within 1 week after exercise intervention
Results and safety
The study was stopped early (reason given: Funding has expired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
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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.
Aditi Gupta, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise in people with Cognitive Impairment and End-Stage Renal Disease, run by University of Kansas Medical Center 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 4 inclusion and 14 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: stopped early, as of the sponsor's last update on 29 Mar 2019. 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?
The study was stopped early (reason given: Funding has expired). Results are not available in the source record.
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?
Feasibility (time frame: Up to 26 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2019.