Interventions Made to Preserve Cognitive Function

NCT03616535 | Terminated Results DMC

• 2 other identifiers: IRB00152858R01DK114074
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

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).

Conditions

ESRD

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (11)

• Change in Global Cognitive Function as Measured by the Montreal Cognitive Assessment (MoCA)

  Baseline, 3 months

• Number of Participants Completing Executive Function as Measured by the Stroop Test

  3 months

• Change in Executive Function as Measured by the Digit Symbol Substitution Test

  baseline and 3 months

• Change in Physical Function as Measured by the Short Physical Performance Battery (SPPB) Test

  Baseline and 3 months

• Number of Participants With an Injurious Fall

  12 months

Study Arms (4)

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.

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."

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).

Other: Combined cognitive and exercise training

Standard of Care

NO INTERVENTION

Participants in this arm will receive standard of care

Interventions

Cognitive training OTHER

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

Also known as: CT

Cognitive training

Exercise training OTHER

The investigators will provide participants with foot peddlers.

Also known as: ET

Exercise training

Combined cognitive and exercise training OTHER

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

Also known as: CT+ET

Combined cognitive and exercise training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older at enrollment
• English speaking
• within 3 months to 3 years of initiating hemodialysis
• receiving hemodialysis at participating dialysis centers

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

Location

New York University Langone Health

New York, New York, 10016, United States

Location

Related Publications (2)

• 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.

  PMID: 35018639 DERIVED

• 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.

  PMID: 32883245 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Cognitive Training; Exercise

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Mara McAdams DeMarco
• Organization: NYU Grossman School of Medicine and Langone Health

mara.mcadamsdemarco@nyulangone.org

1-646-987-1358

Study Officials

• Aarti Mathur, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: August 6, 2018
• Study Start: August 30, 2018
• Primary Completion: June 23, 2023
• Study Completion: September 20, 2023
• Last Updated: July 16, 2025
• Results First Posted: April 11, 2025

Record last verified: 2025-06

Locations

US (2)