Patient active time during therapy sessions in postacute rehabilitation: Development and validation of a new measure

BACKGROUND AND PURPOSE: The accurate measurement of therapy intensity in postacute rehabilitation is important for research to improve outcomes in this setting. We developed and validated a measure of Patient Active Time during physical (PT) and occupational therapy (OT) sessions, as a proxy for therapy intensity. METHODS: This measurement validity study was carried out with 26 older adults admitted to a skilled nursing facility (SNF) for postacute rehabilitation with a variety of main underlying diagnoses, including hip fracture, cardiovascular diseases, stroke, and others. They were participants in a randomized controlled trial that compared an experimental high-intensity therapy to standard-of-care therapy. Patient Active Time was observed by research raters as the total number of minutes that a patient was actively engaging in therapeutic activities during PT and OT sessions. This was compared to patient movement (actigraphy) quantified during some of the same PT/OT sessions using data from three-dimensional accelerometers worn on the patient’s extremities. RESULTS: Activity measures were collected for 136 therapy sessions. Patient Active Time had high interrater reliability in both PT (r = 0.995, p < 0.001) and OT (r = 0.95, p = 0.012). Active time was significantly correlated with actigraphy in both PT (r = 0.73, p < 0.001) and OT (r = 0.60, p < 0.001) and discriminated between a high-intensity experimental condition and standard of care rehabilitation: in PT, 47.0 ± 13.5 min versus 16.7 ± 10.1 min (p < 0.001) and in OT, 46.2 ± 15.2 versus 27.7 ± 6.6 min (p < 0.001). CONCLUSIONS: Systematic observation of Patient Active Time provides an objective, reliable, and valid index of physical activity during PT and OT treatment sessions that has utility as a real-world alternative to the measurement of treatment intensity. This measure could be used to differentiate higher from lower therapy treatment intensity and to help determine the optimal level of active therapy time for patients in postacute and other settings

Zibotentan in systemic sclerosis-associated chronic kidney disease: a phase II randomised placebo-controlled trial

Background We report results from a phase II randomised placebo-controlled trial assessing zibotentan, a highly selective endothelin receptor antagonist (ERA), in chronic kidney disease (CKD) secondary to systemic sclerosis (SSc). Methods This trial included three sub-studies. ZEBRA 1: a randomised placebo-controlled, double-blind, trial of zibotentan in SSc patients with CKD2 or CKD3 (and glomerular filtration rate - GFR >45 ml/min) over 26 weeks. ZEBRA 2A: a 26-week placebo-controlled, single blind trial of zibotentan in scleroderma renal crisis patients not requiring dialysis. ZEBRA 2B: an open label pharmacokinetic study of zibotentan in patients on haemodialysis. Results Sixteen patients were screened for ZEBRA 1. Of these, 6 patients were randomised to zibotentan and 7 to placebo. In ZEBRA 1 there were 47 non-serious adverse events (AE) during the trial. Twentyseven occurred in the placebo group and 20 in the zibotentan group. One serious adverse event (SAE) occurred during ZEBRA1, in the placebo arm. Descriptive statistics did not suggest an effect of study drug on serum sVCAM1. Estimated GFR numerically declined in patients treated with placebo at 26 weeks and 52 weeks. In contrast, average eGFR increased in zibotentan treated cases. The 4 patients in ZEBRA 2A experienced 8 non-serious AEs, distributed equally between placebo and zibotentan. There was one SAE each in placebo and zibotentan groups, both unrelated to study medication. ZEBRA 2B recruited 8 patients, 6 completed first dosing and 2 completed a second dosing visit. Pharmacokinetic analysis confirmed zibotentan levels within the therapeutic range. Three patients experienced 3 non-serious AEs. One SAE occurred and was unrelated to study drug. Conclusions Zibotentan was generally well tolerated. ZEBRA 1 did not show any effect of zibotentan on serum sVCAM-1 but was associated with numerical improvement in eGFR at 26 weeks that was more marked at 52 weeks. ZEBRA 2B suggested a feasible dose regimen for haemodialysis patients