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Interventions Made to Preserve Cognitive Function (IMPCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03616535
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : September 9, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Johns Hopkins University

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).

Condition or disease Intervention/treatment Phase
ESRD Other: Cognitive training Other: Exercise training Other: Combined cognitive and exercise training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Hemodialysis-based Interventions to Preserve Cognitive Function
Actual Study Start Date : August 30, 2018
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Active Comparator: 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.
Other: Cognitive training
The investigators will provide participants with tablets to play brain games.
Other Name: CT

Active Comparator: 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."
Other: Exercise training
The investigators will provide participants with foot peddlers.
Other Name: ET

Active Comparator: 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).
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.
Other Name: CT+ET

No Intervention: Standard of Care
Participants in this arm will receive standard of care



Primary Outcome Measures :
  1. 3 month change in executive function [ Time Frame: 3 months ]
    Change in executive function between baseline and 3 months of interventions as measured by the Trail Making Test which is comprised of Part A and Part B. Executive function is assessed by the time (minutes) to complete Part B minus the time (minutes) to complete Part A. Needing more time to complete the test indicates worse executive function.


Secondary Outcome Measures :
  1. Change in Global Cognitive Function as measured by the Montreal Cognitive Assessment (MoCA) [ Time Frame: 3 months and 6 months ]
    Change in global cognitive function at 3-months and 6 months of interventions as measured by the Montreal Cognitive Assessment (MoCA). This test was designed as a rapid screening instrument for mild cognitive dysfunction. It is a brief 30 question test that assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.Total possible score is 30 points and a score of 26 or above is considered normal.

  2. Change in Executive function as measured by the Stroop test [ Time Frame: 3 months and 6 months ]
    Change in executive function at 3 months and 6 months of interventions as measured by the Stroop Test. The Stroop test is a screening test for cognitive function test and evaluates the inhibitory control of executive function. It is a measure of the ability of the brain to sort out distracting or unnecessary information from the meaningful tasks. It involves reading the name of a color printed in a different color ink. The time ratio of color-word interference and color only tasks will be calculated.

  3. Change in Executive function as measured by the Digit Symbol Substitution Test [ Time Frame: 3 months and 6 months ]
    Change in executive function at 3 months and 6 months of interventions as measure by the Digit Symbol Substitution Test. This test evaluates the speed and working memory components of executive function. It involves a key consisting of the numbers 1-9, each paired with a unique, easy-to--draw symbol such as a "V", "+" or ">". Below the key are a series of the numbers 1-9 in random order and repeated several times. The participant is allowed 90 seconds to fill in the corresponding symbol for each number. This task requires the individual to visually scan the answer key provided at the top of the test and then write the correct symbol by each number as quickly as possible. The correct number of symbols written within 90 seconds is measured.

  4. Change in Physical function as measured by the Short Physical Performance Battery (SPPB) test [ Time Frame: 3 months and 6 months ]
    Change in lower extremity function at 3 months and 6 months of interventions using the SPPB test. The SPPB is an objective assessment tool for evaluating lower extremity functioning This test is a performance-based assessment comprised of 3 tasks: 1) repeated chair stands, 2) standing balance, and 3) a 4-meter usual paced walk in those with and without a walking aid (meters/second). Participants receive a score of 0 for a task if they were unable to complete the task; otherwise, they receive scores of 1-4 based on population-based norms. The scores of the three tasks are summed to create the SPPB score. The SPPB score ranges from 0 to 12, with lower scores indicating poorer function.

  5. Number of Falls [ Time Frame: 12 months ]
    Number of injurious falls resulting in a medical encounter during the 6 months of interventions and for 6 months after the interventions

  6. Number of Hospitalizations [ Time Frame: 12 months ]
    The number of hospitalizations parameterized as both the number of hospital admissions and number of days hospitalized during the 6 months of interventions and 6 months after the interventions

  7. Mortality [ Time Frame: 18 months ]
    Mortality will be captured through Center for Medicare and Medicaid Services (CMS) death notification or the National Death Index. Mortality will be ascertained within the 6 months of the intervention and 1 year after the intervention (1.5 years total).

  8. Change in Patient-centered Outcomes as measured by the Kidney Disease Quality of Life (KDQOL) Survey [ Time Frame: 3 months and 6 months ]
    Change in kidney disease-specific physical and mental quality of life at 3 months and 6 months of interventions. The KDQOL s a kidney disease-specific measure of how kidney disease is impacting a participant's quality of life. It is a 36-item survey with 3 subscales including physical and mental health-related quality of life, and kidney disease-specific HRQOL. Each subscale is scored 0 to 100 with higher scores indicating better HRQOL.

  9. Change in Patient-centered Outcomes as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 [ Time Frame: 3 months and 6 months ]
    Change in the participants' physical, mental, and social health status at 3 months and 6 months of interventions. PROMIS-29 is a health-related quality of life survey which assesses each of the 7 PROMIS domains with 4 questions. Norm-based scores have been calculated for each domain on the PROMIS measures. High scores represent more of the domain being measured. Thus, on symptom-oriented domains of PROMIS-29 (anxiety, depression, fatigue, pain interference, and sleep disturbance), higher scores represent worse symptomatology. On the function-oriented domains (physical functioning and social role) higher scores represent better functioning.

  10. Amputations [ Time Frame: 12 months ]
    the incidence (number) of amputations during the 6 months of interventions and 6 months after interventions. This information will be either self-reported by the participant or abstracted from their medical records to see if the interventions are associated with amputations

  11. Return to work status [ Time Frame: 12 months ]
    the number of participants able to return to work during the 6 months of interventions and 6 months after interventions.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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: Patients with the following conditions will be excluded:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616535


Contacts
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Contact: Mara McAdams DeMarco, PhD 410-502-1950 mara@jhu.edu
Contact: Malu B Steckel, DVM 443-287-0613 mmooney6@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins School of Medicine Recruiting
Baltimore, Maryland, United States, 21205
Contact: Malu B. Steckel, DVM    443-287-0613    mmooney6@jhmi.edu   
Contact: Eileen Rosello    410-502-6942      
Sponsors and Collaborators
Johns Hopkins University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Mara McAdams Demarco, PhD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03616535    
Other Study ID Numbers: IRB00152858
R01DK114074 ( U.S. NIH Grant/Contract )
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No