← Back to Search

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

Must not have

Chronic lung disease requiring oxygen

Orthopedic disorders exacerbated by physical activity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months and 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am currently receiving hemodialysis at a participating center.

Select...

I am 18 years old or older.

Select...

I started hemodialysis between 3 months and 3 years ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need oxygen therapy for my chronic lung condition.

Select...

My bone or joint condition gets worse with physical activity.

Select...

I have had an arm or leg amputated.

Select...

I have chest pain due to heart problems.

Select...

I have a condition that limits my ability to move.

Select...

I have Hepatitis B.

Select...

I am legally blind.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in executive function as assessed by the Trail Making Test

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 10Eligibility criteria met