Interventions Made to Preserve Cognitive Function

NCT ID: NCT03616535

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-30
• Study Completion Date: 2023-09-20

Brief 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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cognitive training

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.

Group Type: ACTIVE_COMPARATOR

Cognitive training

Intervention Type: OTHER

The investigators will provide participants with tablets to play brain games.

Exercise training

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 Type: ACTIVE_COMPARATOR

Exercise training

Intervention Type: OTHER

The investigators will provide participants with foot peddlers.

Combined cognitive and exercise training

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 Type: ACTIVE_COMPARATOR

Combined cognitive and exercise training

Intervention Type: OTHER

The investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training.

Standard of Care

Participants in this arm will receive standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive training

The investigators will provide participants with tablets to play brain games.

Intervention Type: OTHER

Exercise training

The investigators will provide participants with foot peddlers.

Intervention Type: OTHER

Combined cognitive and exercise training

The investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training.

Intervention Type: OTHER

Other Intervention Names

CT; ET; CT+ET

Eligibility Criteria

Inclusion Criteria

• 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

• Pregnancy
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aarti Mathur, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

New York University Langone Health

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35018639 (View on PubMed)

McAdams-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.

Reference Type: DERIVED

PMID: 32883245 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01DK114074

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00152858

Identifier Type: -

Identifier Source: org_study_id