ESRDIMPCTNCT03616535
Interventions Made to Preserve Cognitive Function
A study testing Cognitive training, Exercise training and Combined cognitive and exercise training in people with ESRD, run by Johns Hopkins University at 2 sites in United States.
Trial summary
This is a randomized, controlled trial to slow cognitive decline in adults undergoing hemodialysis (HD). The investigators will test three interventions cognitive training (CT), exercise training (ET), and combined cognitive and exercise training (CT+ET) relative to standard of care (SC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESRD
- What is being tested?
- Cognitive training, Exercise training and Combined cognitive and exercise training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Aug 2018to 20 Sep 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older at enrollment
- English speaking
- within 3 months to 3 years of initiating hemodialysis
- receiving hemodialysis at participating dialysis centers
- Exclusion Criteria: Patients with the following conditions will be excluded:
- Pregnancy
Show all 15Show fewer
- Angina Pectoris
- Chronic lung disease requiring oxygen
- Musculoskeletal conditions that limit mobility
- Upper or lower extremity amputation
- Orthopedic disorders exacerbated by physical activity
- Femoral arteriovenous (AV) access
- Hepatitis B infection
- Blindness/Legal blindness
- In addition to conditions outlined above, patients who are currently incarcerated will be excluded from the study.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins School of Medicine
Baltimore, Maryland, 21205
New York University Langone Health
New York, New York, 10016
About this study
Official title: Hemodialysis-based Interventions to Preserve Cognitive Function
This is a randomized, controlled trial to slow cognitive decline in adults undergoing hemodialysis (HD). The investigators will test three interventions cognitive training (CT), exercise training (ET), and combined cognitive and exercise training (CT+ET) relative to standard of care (SC).
Read the detailed description
This will be a two by two factorial, randomized, controlled trial to slow cognitive decline in adults undergoing hemodialysis (HD). The investigators primary objective is to determine if receiving cognitive training (tablet-based brain games), exercise training (stationary foot pedal), or combined cognitive and exercise training preserves executive function relative to those with standard of care . The secondary objectives are to compare the rates of end stage renal disease (ESRD)-specific clinical outcomes and patient centered outcomes among those receiving CT, or ET, or CT+ET relative to those in SC. The investigators will formally test whether receiving CT or ET will preserve executive function and receiving combined CT+ET will preserve executive function better than CT or ET alone.
- Conditions
- ESRD
- Being tested
- Cognitive training, Exercise training, Combined cognitive and exercise training
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingOther
Also called CT
The investigators will provide participants with tablets to play brain games.
Exercise trainingOther
Also called ET
The investigators will provide participants with foot peddlers.
Combined cognitive and exercise trainingOther
Also called CT+ET
The investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive training | Active comparator | Participants randomized to CT will play "brain games" on a tablet. They will be asked to engage in the activity for a minimum of 30 minutes during each hemodialysis session for 6 months. At each HD session, participants will have 10 different brain games to play and the games will vary for each session. Receives: Other: Cognitive training |
| Exercise training | Active comparator | Participants randomized to the ET arm will be given a stationary foot peddler and will be asked to engage in the activity for a minimum of 30 minutes at each hemodialysis session for 6 months. ET will start with a 2 minute warm up, then the resistance will be adjusted so that participants are working at perceived exertion of "somewhat strong," using the Borg scale (87) (~50 rpm). Resistance will be increased when the rating falls below "somewhat hard." Receives: Other: Exercise training |
| Combined cognitive and exercise training | Active comparator | Participants in the CT+ET arm will start with 30 minutes of CT (playing "brain games" on tablet) with a 15-minute break, and then, 30 minutes of ET (stationary foot peddler). Receives: Other: Combined cognitive and exercise training |
| Standard of Care | No intervention | Participants in this arm will receive standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Executive Function as Assessed by the Trail Making Test Assessment (TMT)
Change in executive function between baseline and 3 months as assessed by the Trail Making Test which is comprised of Part A and Part B. Executive function is assessed by the time (seconds) to complete Part B minus the time (seconds) to complete Part A. Needing more time to complete the test indicates worse executive function.
Measured: 3 months
Secondary outcomes (11)
Change in Global Cognitive Function as Measured by the Montreal Cognitive Assessment (MoCA)
Change in global cognitive function at 3-months of interventions as measured by the Montreal Cognitive Assessment (MoCA). It is a brief 30 question test that assesses different cognitive domains: attention and concentration, executive functions, memory, language, visual construction skills, conceptual thinking, calculations, and orientation. Total possible score range is 0-30 points, and a score of 26 or above is considered normal.
Measured: Baseline, 3 months
Number of Participants Completing Executive Function as Measured by the Stroop Test
Number completing the Stroop test of executive function at 3 months of interventions. The Stroop test asks participants to view two conflicting pieces of information, specifically the word itself and the color of the ink it's printed in. Participants are asked to name the color of the ink used to print words, rather than reading the words themselves.
Measured: 3 months
Change in Executive Function as Measured by the Digit Symbol Substitution Test
Change in executive function at 3 months of interventions as measure by the Digit Symbol Substitution Test. This test evaluates the speed and working memory components of executive function. It involves a key consisting of the numbers 1-9, each paired with a unique, easy-to--draw symbol such as a "V", "+" or ">". Below the key are a series of the numbers 1-9 in random order and repeated several times. The participant is allowed 90 seconds to fill in the corresponding symbol for each number. This task requires the individual to visually scan the answer key provided at the top of the test and then write the correct symbol by each number as quickly as possible. The correct number of symbols written within 90 seconds is measured. Total possible score ranges from a minimum of 0 to a maximum of 90 points. Higher scores represent better outcomes.
Measured: baseline and 3 months
Change in Physical Function as Measured by the Short Physical Performance Battery (SPPB) Test
Change in lower extremity function at 3 months of interventions using the SPPB test. The SPPB is an objective assessment tool for evaluating lower extremity functioning This test is a performance-based assessment comprised of 3 tasks: 1) repeated chair stands, 2) standing balance, and 3) a 4-meter usual paced walk in those with and without a walking aid (meters/second). Participants receive a score of 0 for a task if they were unable to complete the task; otherwise, they receive scores of 1-4 based on population-based norms. The scores of the three tasks are summed to create the SPPB score. The SPPB score ranges from 0 to 12, with lower scores indicating poorer function.
Measured: Baseline and 3 months
Number of Participants With an Injurious Fall
Number of participants with an injurious falls resulting in a medical encounter during the 6 months of interventions and for 6 months after the interventions
Measured: 12 months
Number of Participants With a Hospitalizations
The number of participants with a hospitalizations during the 6 months of interventions and 6 months after the interventions
Measured: 12 months
Mortality
Mortality will be ascertained within the 6 months of the intervention and 1 year after the intervention (1.5 years total).
Measured: 18 months
Change in Patient-centered Outcomes as Measured by the Kidney Disease Quality of Life (KDQOL) Survey
Change in kidney disease-specific physical and mental quality of life at 3 months. Using a single the question from the KDQOL: In general, would you say your health is ___ ? It is reported on a 5-point score: 1, poor; 2, fair; 3, good; 4, very good; 5, excellent. Higher is better. While the score of KDQOL ranges from 1 to 5 points, we are measuring the 3-month change in this score. Therefore, the change could range from -4 to 4 points.
Measured: Baseline and 3 months
Change in Patient-centered Outcomes as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Change in Patient-centered Outcomes as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 The change in PROMIS-29 score at 3 months is reported. Scores range from 0-140; higher scores are better.
Measured: Baseline and 3 months
Number of Participants With an Amputation
The number of participants with an amputation during the 6 months of interventions and 6 months after interventions. This information will be either self-reported by the participant or abstracted from the medical records to see if the interventions are associated with amputations
Measured: 12 months
Number of Participants Able to Return to Work
The number of participants able to return to work during the 6 months of interventions and 6 months after interventions.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start30 Aug 2018
- Primary completion23 Jun 2023
- Study completion20 Sep 2023
Why it stopped: DSMB terminated study due to COVID-19 delays in recruitment
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 (2)Papers the sponsor has linked to this study.
- Other trials for ESRDStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aarti Mathur, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616535
- Sponsor's protocol ID
- IRB00152858
- Other IDs
- R01DK114074
- Acronym
- IMPCT
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2018
- Last updated
- 16 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
PubMed 35018639McAdams-DeMarco MA, Chu NM, Steckel M, Kunwar S, Gonzalez Fernandez M, Carlson MC, Fine DM, Appel LJ, Diener-West M, Segev DL. Interventions Made to Preserve Cognitive Function Trial (IMPCT) study protocol: a multi-dialysis center 2x2 factorial randomized controlled trial of intradialytic cognitive and exercise training to preserve cognitive function. BMC Nephrol. 2020 Sep 3;21(1):383. doi: 10.1186/s12882-020-02041-y.
PubMed 32883245
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodialysis-based Interventions to Preserve Cognitive Function
- ClinicalTrials.gov ID
- NCT03616535
- Acronym / sponsor ID
- IMPCT / IRB00152858
- Conditions
- ESRD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB terminated study due to COVID-19 delays in recruitment
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Posted 11 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, controlled trial to slow cognitive decline in adults undergoing hemodialysis (HD). The investigators will test three interventions cognitive training (CT), exercise training (ET), and combined cognitive and exercise training (CT+ET) relative to standard of care (SC).
Detailed description
This will be a two by two factorial, randomized, controlled trial to slow cognitive decline in adults undergoing hemodialysis (HD). The investigators primary objective is to determine if receiving cognitive training (tablet-based brain games), exercise training (stationary foot pedal), or combined cognitive and exercise training preserves executive function relative to those with standard of care . The secondary objectives are to compare the rates of end stage renal disease (ESRD)-specific clinical outcomes and patient centered outcomes among those receiving CT, or ET, or CT+ET relative to those in SC. The investigators will formally test whether receiving CT or ET will preserve executive function and receiving combined CT+ET will preserve executive function better than CT or ET alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitive training | Active comparator | Other: Cognitive trainingParticipants randomized to CT will play "brain games" on a tablet. They will be asked to engage in the activity for a minimum of 30 minutes during each hemodialysis session for 6 months. At each HD session, participants will have 10 different brain games to play and the games will vary for each session. |
| Exercise training | Active comparator | Other: Exercise trainingParticipants randomized to the ET arm will be given a stationary foot peddler and will be asked to engage in the activity for a minimum of 30 minutes at each hemodialysis session for 6 months. ET will start with a 2 minute warm up, then the resistance will be adjusted so that participants are working at perceived exertion of "somewhat strong," using the Borg scale (87) (~50 rpm). Resistance will be increased when the rating falls below "somewhat hard." |
| Combined cognitive and exercise training | Active comparator | Other: Combined cognitive and exercise trainingParticipants in the CT+ET arm will start with 30 minutes of CT (playing "brain games" on tablet) with a 15-minute break, and then, 30 minutes of ET (stationary foot peddler). |
| Standard of Care | No intervention | –Participants in this arm will receive standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 18 years or older at enrollment
- English speaking
- within 3 months to 3 years of initiating hemodialysis
- receiving hemodialysis at participating dialysis centers
- Pregnancy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cognitive trainingAlso: CTThe investigators will provide participants with tablets to play brain games. | Other | Cognitive training |
| Exercise trainingAlso: ETThe investigators will provide participants with foot peddlers. | Other | Exercise training |
| Combined cognitive and exercise trainingAlso: CT+ETThe investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training. | Other | Combined cognitive and exercise training |
Primary outcome
Change in Executive Function as Assessed by the Trail Making Test Assessment (TMT)
Time frame: 3 months
Change in executive function between baseline and 3 months as assessed by the Trail Making Test which is comprised of Part A and Part B. Executive function is assessed by the time (seconds) to complete Part B minus the time (seconds) to complete Part A. Needing more time to complete the test indicates worse executive function.
11 secondary outcomes
Change in Global Cognitive Function as Measured by the Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, 3 months
Number of Participants Completing Executive Function as Measured by the Stroop Test
Time frame: 3 months
Change in Executive Function as Measured by the Digit Symbol Substitution Test
Time frame: baseline and 3 months
Change in Physical Function as Measured by the Short Physical Performance Battery (SPPB) Test
Time frame: Baseline and 3 months
Number of Participants With an Injurious Fall
Time frame: 12 months
Number of Participants With a Hospitalizations
Time frame: 12 months
Mortality
Time frame: 18 months
Change in Patient-centered Outcomes as Measured by the Kidney Disease Quality of Life (KDQOL) Survey
Time frame: Baseline and 3 months
Change in Patient-centered Outcomes as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Time frame: Baseline and 3 months
Number of Participants With an Amputation
Time frame: 12 months
Number of Participants Able to Return to Work
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35018639Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
- Derived from this study: PubMed 32883245McAdams-DeMarco MA, Chu NM, Steckel M, Kunwar S, Gonzalez Fernandez M, Carlson MC, Fine DM, Appel LJ, Diener-West M, Segev DL. Interventions Made to Preserve Cognitive Function Trial (IMPCT) study protocol: a multi-dialysis center 2x2 factorial randomized controlled trial of intradialytic cognitive and exercise training to preserve cognitive function. BMC Nephrol. 2020 Sep 3;21(1):383. doi: 10.1186/s12882-020-02041-y.
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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.
Aarti Mathur, MD, PhD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training, Exercise training and Combined cognitive and exercise training in people with ESRD, run by Johns Hopkins University at 2 sites 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 15 inclusion and 0 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 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 11 Apr 2025). 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?
Change in Executive Function as Assessed by the Trail Making Test Assessment (TMT) (time frame: 3 months). 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 NCT03616535, which also lists 2 linked publications.
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 16 Jul 2025; AzTrials last refreshed its copy on 30 Oct 2026.