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Table 1 Overview of primary and secondary outcomes

From: Cardiovascular rehabilitation soon after stroke using feedback-controlled robotics-assisted treadmill exercise: study protocol of a randomised controlled pilot trial

Variable

Details

Unit

Primary outcomes (Aerobic capacity)

  

Peak oxygen uptake (VO2peak)

Peak oxygen uptake in the last 30 s during IET

mL/min, mL/min/kg

Peak work rate (Ppeak)

Maximal work rate during IET

W

Peak heart rate (HRpeak)

Maximal heart rate during IET

beats/min

Peak ventilation rate (VEpeak)

Peak ventilation rate in the last 30 s during IET

L/min

Peak respiratory rate (Rfpeak)

Peak respiratory rate in the last 30 s during IET

1/min

Peak respiratory exchange ratio (RERpeak)

Value of the oxygen uptake and carbon dioxide output relationship at peak oxygen uptake

dimensionless

Gas exchange threshold (GET)

Oxygen uptake at the point at which carbon dioxide output begins to increase more rapidly in proportion to oxygen uptake during IET. Estimated using the v-slope method and standard gas exchange criteria

mL/min, mL/min/kg

Oxygen cost of work (ΔVO2/ΔP)

Δ oxygen uptake/Δ work rate

mL/min/W

Heart rate response (ΔHR/ΔVO2)

Δ heat rate/Δ oxygen uptake

beats/mL/min

Peak oxygen pulse (VO2peak/HRpeak)

Peak oxygen uptake/peak heart rate

mL/beat

Time constants of oxygen uptake during on-/off-transition (Ï„)

Time taken for oxygen uptake to reach 63% of its increment magnitude, when the response is modelled as a mono-exponential function during CLT

s

Steady-state increase in oxygen uptake (ΔVO2)

Steady-state increase in oxygen uptake following a step increase/decrease in exercise intensity during CLT

mL/min, mL/min/kg

Steady-state increase in heart rate (ΔHR)

Steady-state increase in heart rate following a step increase/decrease in exercise intensity during CLT

beats/min

Steady-state increase in ventilation rate (ΔVE)

Steady-state increase in minute rate following a step increase/decrease in exercise intensity during CLT

L/min

Steady-state increase in respiratory rate (ΔRf)

Steady-state increase in respiratory rate following a step increase/decrease in exercise intensity during CLT

1/min

Oxygen cost of work during constant load (VO2/P)

Oxygen uptake versus work rate during passive and active constant load phases

mL/min/W

Secondary outcomes

  

RMS deviation of work rate RMSEP

Work rate tracking error during feedback-controlled robotics-assisted treadmill exercise

W

Gait speed

10 Meter Walk Test (10MWT)

m/s

Walking endurance

6 Minute Walk Test (6MWT)

m

Standing function

Standardised protocol to assess standing using a force plate

%, mm

Quality-of-life

Stroke Impact Scale (SIS)

Score

Feasibility

Criteria for success

4 scale rating

  1. CLT, Constant load testing; IET, incremental exercise testing; RMSE, root mean square error.