Cognitive + Exercise Training for Cognitive Decline in Renal Disease

(IMPCT Trial)

Recruiting at 1 trial location

Overseen By Carolyn B Sidoti

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Pregnancy, Angina, Lung disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

130 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Aarti Mathur, MD, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.

Inclusion Criteria

I am currently receiving hemodialysis at a participating center.

I started hemodialysis between 3 months and 3 years ago.

English speaking

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cognitive training, exercise training, or combined cognitive and exercise training during hemodialysis sessions

6 months

During each hemodialysis session

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term Follow-up

Mortality and other long-term outcomes are monitored

1 year

Treatment Details

Interventions

• Cognitive training
• Combined cognitive and exercise training
• Exercise training

Trial Overview 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.

Participant Groups

Group I: Combined cognitive and exercise training Active Control 1 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 training Active Control 1 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 Care Active Control 1 Intervention

Participants in this arm will receive standard of care

Group IV: Cognitive training Active Control 1 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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+