biostudies-literatureBirkeland KNCATS NIH HHSNCRR NIH HHSNHLBI NIH HHSe255https://www.ebi.ac.uk/biostudies/studies/S-EPMC5752966biostudies-literatureUnknown6(12)<h4>Background</h4>Digital wearable devices provide a "real-world" assessment of physical activity and quantify intervention-related changes in clinical trials. However, the value of digital wearable device-recorded physical activity as a clinical trial outcome is unknown.<h4>Objective</h4>Because late sodium channel inhibition (ranolazine) improves stress laboratory exercise duration among angina patients, we proposed that this benefit could be quantified and translated during daily life by measuring digital wearable device-determined step count in a clinical trial.<h4>Methods</h4>We conducted a substudy in a randomized, double-blinded, placebo-controlled, crossover trial of participants with angina and coronary microvascular dysfunction (CMD) with no obstructive coronary artery disease tJMIR research protocolsDaily Activity Measured With Wearable Technology as a Novel Measurement of Treatment Effect in Patients With Coronary Microvascular Dysfunction: Substudy of a Randomized Controlled Crossover Trial.PMC5752966UL1 TR000124UM1 HL087366UL1 RR033176N01HV68163N01HV68162UL1 TR001427R01 HL033610M01 RR000425K23 HL105787R01 HL056921N01 HV068164R37 HL033610R01 HL089765T32 HL116273N01 HV068161Shufelt CLAnderson RDThomson LECook-Wiens GMehta PKBirkeland KKhandwalla RMBerman DSMinissian MBBairey Merz CNPetersen JWHandberg EMKedan IWei JPepine CJfalseDaily Activity Measured With Wearable Technology as a Novel Measurement of Treatment Effect in Patients With Coronary Microvascular Dysfunction: Substudy of a Randomized Controlled Crossover Trial.<h4>Background</h4>Digital wearable devices provide a "real-world" assessment of physical activity and quantify intervention-related changes in clinical trials. However, the value of digital wearable device-recorded physical activity as a clinical trial outcome is unknown.<h4>Objective</h4>Because late sodium channel inhibition (ranolazine) improves stress laboratory exercise duration among angina patients, we proposed that this benefit could be quantified and translated during daily life by measuring digital wearable device-determined step count in a clinical trial.<h4>Methods</h4>We conducted a substudy in a randomized, double-blinded, placebo-controlled, crossover trial of participants with angina and coronary microvascular dysfunction (CMD) with no obstructive coronary artery disease t2017-01-01T00:00:00Z2017 Dec2025-04-04T12:31:39.117Z2019-03-27T03:06:18ZS-EPMC57529662926301910.2196/resprot.8057