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Table 2 Primary and Secondary Endpoints for the Interventions Made to Preserve Cognitive Function Trial (IMPCT)

From: 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

Primary Endpoint(s)

3-month change in executive function measured using the Trail Making Test Part A (TMTA) and Part B (TMTB). Executive function is measured as TMTB-TMTA.

Secondary Endpoint(s)

1. Secondary cognitive measures (change in)

a. 6-month executive function (TMTB-TMTA)

b. 3- and 6-month executive function (additional measures)

c. 3- and 6-month memory

d. 3- and 6-month global cognitive function

2. ESKD-specific clinical measures

a. Measured physical function

b. Number of falls

c. Hospitalization

d. Mortality

e. Return to work

f. Amputation

3. Patient-centered outcomes

a. HRQOL

b. Anxiety

c. Depression

d. Fatigue

e. Pain interference

f. Perceived physical function

g. Sleep disturbance

h. Ability to participate in social roles and activities