Study 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.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 11 Secondary · Reporting Duration: 3 months and 6 months
12 months
Amputations
Number of Falls
Number of Hospitalizations
Return to work status
18 months
Mortality
3 months
3 month change in executive function
Month 6
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)
Change in Patient-centered Outcomes as measured by the Kidney Disease Quality of Life (KDQOL) Survey
Change in Patient-centered Outcomes as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Change in Physical function as measured by the Short Physical Performance Battery (SPPB) test
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
Exercise training
1 of 4
Standard of Care
1 of 4
Cognitive training
1 of 4
Combined cognitive and exercise training
1 of 4
Active Control
200 Total Participants · 4 Treatment Groups
Primary Treatment: Exercise training · No Placebo Group · N/A
Exercise training
Other
ActiveComparator Group · 1 Intervention: Exercise training · Intervention Types: OtherStandard of CareNoIntervention Group · 1 Intervention: Standard of Care · Intervention Types:
Cognitive training
Other
ActiveComparator Group · 1 Intervention: Cognitive training · Intervention Types: OtherCombined cognitive and exercise training
Other
ActiveComparator Group · 1 Intervention: Combined cognitive and exercise training · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months and 6 months
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,148 Previous Clinical Trials
4,074,579 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,076 Previous Clinical Trials
31,019,993 Total Patients Enrolled
Aarti Mathur, MD, PhDPrincipal InvestigatorJohns Hopkins University
Nadia M Chu, PhDPrincipal InvestigatorJohns Hopkins University
Mara McAdams Demarco, PhDPrincipal InvestigatorJohns Hopkins University
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have been on hemodialysis for at least 3 months.
You are 18 years or older at enrollment.\n
You are receiving hemodialysis at participating dialysis centers.
References
- McAdams-DeMarco, Mara A., Nadia M. Chu, Malu Steckel, Sneha Kunwar, Marlís González Fernández, Michelle C. Carlson, Derek M. Fine, Lawrence J. Appel, Marie Diener-West, and Dorry L. Segev. 2020. “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 Nephrology. Springer Science and Business Media LLC. doi:10.1186/s12882-020-02041-y.
- 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:CD014653. doi: 10.1002/14651858.CD014653. Review.
- 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.
- 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.
- 2018. "Interventions Made to Preserve Cognitive Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03616535.
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Conditions
Cancer Related
Treatments