Exercise training for End-Stage Renal Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
End-Stage Renal DiseaseCognitive training - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

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

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: Other
Standard of CareNoIntervention Group · 1 Intervention: Standard of Care · Intervention Types:
Cognitive training
Other
ActiveComparator Group · 1 Intervention: Cognitive training · Intervention Types: Other
Combined cognitive and exercise training
Other
ActiveComparator Group · 1 Intervention: Combined cognitive and exercise training · Intervention Types: Other

Trial 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