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Cognitive + Exercise Training for Cognitive Decline in Renal Disease (IMPCT Trial)
N/A
Waitlist Available
Led By Nadia M Chu, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
receiving hemodialysis at participating dialysis centers
18 years or older at enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months and 6 months
Awards & highlights
IMPCT Trial Summary
This trial will test whether cognitive training, exercise training, or a combination of the two can help slow cognitive decline in adults undergoing hemodialysis.
Who is the study for?
This trial is for English-speaking adults over 18 who started hemodialysis between 3 months to 3 years ago at participating centers. It's not for those with severe heart or lung conditions, hepatitis B, mobility issues due to musculoskeletal conditions or amputations, blindness, orthopedic disorders worsened by exercise, or those pregnant or incarcerated.Check my eligibility
What is being tested?
The study compares three approaches—cognitive training (CT), exercise training (ET), and a combination of both (CT+ET)—against the usual care given to slow down cognitive decline in adults on hemodialysis. Participants are randomly assigned to one of these groups.See study design
What are the potential side effects?
Potential side effects may include physical strain from exercise which could exacerbate existing musculoskeletal problems. Cognitive training might cause mental fatigue. The combined intervention could lead to increased fatigue from both activities.
IMPCT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently receiving hemodialysis at a participating center.
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I am 18 years old or older.
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I started hemodialysis between 3 months and 3 years ago.
IMPCT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in executive function as assessed by the Trail Making Test
Secondary outcome measures
Change in Executive function as measured by the Digit Symbol Substitution Test
Change in Executive function as measured by the Stroop test
Change in Global Cognitive Function as measured by the Montreal Cognitive Assessment (MoCA)
+8 moreIMPCT Trial Design
4Treatment groups
Active Control
Group I: Combined cognitive and exercise trainingActive Control1 Intervention
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).
Group II: Exercise trainingActive Control1 Intervention
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."
Group III: Standard of CareActive Control1 Intervention
Participants in this arm will receive standard of care
Group IV: Cognitive trainingActive Control1 Intervention
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.
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,259 Previous Clinical Trials
14,820,532 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,357 Previous Clinical Trials
4,315,065 Total Patients Enrolled
Nadia M Chu, PhDPrincipal InvestigatorJohns Hopkins University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I need oxygen therapy for my chronic lung condition.My bone or joint condition gets worse with physical activity.You have a type of access in your leg called femoral arteriovenous (AV) access.You are pregnant.I have had an arm or leg amputated.I have chest pain due to heart problems.I have a condition that limits my ability to move.I am currently receiving hemodialysis at a participating center.I have Hepatitis B.I am 18 years old or older.I started hemodialysis between 3 months and 3 years ago.I am legally blind.
Research Study Groups:
This trial has the following groups:- Group 1: Combined cognitive and exercise training
- Group 2: Exercise training
- Group 3: Standard of Care
- Group 4: Cognitive training
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current capacity of this medical trial?
"Affirmative. According to the information published on clinicaltrials.gov, this research endeavour is actively recruiting participants after first being posted on August 30th 2018 and lastly updated on January 25th 2022. 200 volunteers are needed from a single site for full enrolment in this trial."
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Are there any available slots in this investigation?
"Confirmed, the trial is still enrolling participants. It was initially posted on August 30th 2018 and the entry was revised as recently as January 25th 2022."
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