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. 2024 Oct 12;7:279. doi: 10.1038/s41746-024-01268-5

Table 1.

Study characteristics

Authors, year n Country Study type Device Type of device Measure techniques Functions Medical grade MDRL
Single measurement technique
Alosco et al.18 96 USA OBS ActiGraph GT1M Wrist-worn device ACC PAa MDR C I, FDA C II 6
Alosco et al.16 65 USA OBS ActiGraph GT1M Wrist-worn device ACC PAa MDR C I, FDA C II 6
Alosco et al.17 57 USA OBS Actigraph GT1M Wrist-worn device ACC PAa MDR C I, FDA C II 6
Baril et al.21 50 CAN OBS Fitbit Flex Wrist-worn device ACC PA - 6
Blomqvist et al.24 605 SWE OBS ActiGraph GT9X Wrist-worn device ACC PAa MDR C I, FDA C II 6
Braun et al.25 61 DEU OBS wearable IMU (inertial measurement units) system (Rehagait®, Hasomed, Magdeburg, Germany Ankles-worn ACC PA - 6
Butler et al.28 69 USA RCT ActiGraph GT9X Wrist-worn device ACC PAa MDR C I, FDA C II 6
Da Silva et al.30 16 BRA OBS ActiGraph GT3X Wrist-worn device ACC PAa MDR C I, FDA C II 6
Dibben et al.35 22 GBR OBS GENEActiv, Activinsights Ltd. Wrist- and waist-worn device ACC PA - 5
Dibben et al.36 247 GBR RCT GENEActiv, Activinsights Ltd. Wrist-worn device ACC PA - 7
Dontje et al.37 68 NLD OBS SenseWear® Pro3 Armband Wrist-worn device ACC PA - 6
Edwards et al.39 190 USA OBS ActiGraph AM-7164 Wrist-worn device ACC PAa MDR C I, FDA C II 6
Evangalista et al.41 38 USA RCT Sportline Pedometer Model 330 Hip-worn ACC PA - 6
Floegel et al.43 27 USA OBS ActivPAL3c™ and Tractivity® Wrist-worn device ACC PA - 6
Floegel et al.42 29 USA OBS ActivPAL3c™ and Tractivity® Wrist-worn device ACC PA - 6
Fulcher et al.44 93 USA OBS ActiGraph GT1M Wrist-worn device ACC PAa MDR C I, FDA C II 6
German et al.47 58 USA OBS Kenz Lifecorder Ex Hip-worn ACC PA - 6
Güder et al.48 12 DEU OBS Polar M430 Wrist-worn device ACC PA - 6
Holber et al.52 531 USA OBS SenseWear® Pro3 Wrist-worn device ACC PA - 7
Howie-Esquivel et al.53 32 USA OBS Micro Care Timeliness Monitors Hip- and ankle worn ACC PA - 5
Izawa et al.59 261 JPN OBS Kenz Lifercorder Hip-worn ACC PA - 6
Izawa et al.58 477 JPN OBS Kenz Lifercorder Hip-worn ACC PA - 6
Jehn et al.61 55 DEU OBS StayHealthy Inc. RT3, AiperMotion 300 PfH, OMRON Walking Style Pro Wrist-worn device ACC PA - 5
Jehn et al.60 710 DEU OBSb AiperMotion 300 PfH Hip-worn ACC PA - 6
Klompstra et al.66 32 SWE PT DirectLife TracmorD, Philips Wrist-worn device ACC PA - 6
Klompstra et al.65 64 SWE OBSb ActiGraph GT9X Hip-worn ACC PAa MDR C I, FDA C II 6
Li et al.69 1140 USA OBS Actical, Philips Patch ACC PA, Sleepa FDA C II 6
Lin et al.71 124 GBR OBS Axivity AX3 (Axivity Ltd) Vest ACC PA - 6
McCarthy et al.73 20 USA OBS New Lifestyles NL-800 Hip-worn ACC PA - 6
Melczer et al.74 17 HUN OBS ActiGraph GT3X Wrist-worn device ACC PAa MDR C I, FDA C II 6
Melin et al.75 60 SWE OBS ActiGraph GT3X Wrist-worn device ACC PAa MDR C I, FDA C II 6
Miyahara et al.76 70 JPN OBS Omron HJA-350IT Hip-worn ACC PA - 6
Nelson et al.79 93 USA OBS Actigraph GT3X Wrist-worn device ACC PAa MDR C I, FDA C II 6
O’Donnell et al.80 596 GBR OBS Axivity AX3 Wrist-worn device ACC PA - 6
Okwose et al.81 20 GBR OBS Omron HJ-321-E Hip-worn ACC PA - 6
Omar et al.82 63 DNK OBS Actigraph GT3X Wrist-worn device ACC PAa MDR C I, FDA C II 6
Pozehl et al.85 182 USA OBS ActiGraph GT3X Wrist-worn device ACC PAa MDR C I, FDA C II 6
Prescher et al.86 155 DEU OBSb AiperMotion 300 PfH Wrist-worn device ACC PA - 6
Radhakrishnan et al.87 10 USA OBS Withings Go activity tracker Wrist-worn device ACC PA - 6
Rullman et al.89 94 SWE OBS Actigraph GT3X Wrist-worn device ACC PAa MDR C I, FDA C II 6
Schmidt et al.92 22 PRT OBS ActiGraph GT3X Wrist-worn device ACC PAa MDR C I, FDA C II 6
Schoemaker et al.97 22 USA OBS Stayhealthy Inc. RT3 Hip-worn ACC PA - 5
Schwendinger et al.93 56 USA OBS GENEActiv, Activinsights Ltd. Wrist-worn device ACC PA - 6
Shen et al.95 40 CHN OBS ActiGraph GT3X Wrist-worn device ACC PAa MDR C I, FDA C II 6
Shiraishi et al.96 31 JPN OBS Active Style Pro HJA-750C Waist-Worn ACC PA - 6
Snipelisky et al.99 110 USA OBSb Kinetic Activity Monitors Hip-worn ACC PA - 6
van den Berg-Emons et al.104 5 NLD OBS Custom build system Body- and hip-worn ACC PA - 5
van den Berg-Emons et al.105 36 NLD OBS Custom build system Body- and hip-worn ACC PA - 6
Vetrovsky et al.106 26 CZE OBS Garmin vívofit Wrist- and hip-worn device ACC PA - 6
Vetrovsky et al.107 26 CZE RCT Garmin vívofit, Actigraph wGT3X-BT Wrist-worn device ACC PAa ActiGraph: FDA C II, MDR C I Garmin: 6, ActiGraph: 6
Waring et al.109 50 USA OBS ActiGraph GT3X+ Wrist-worn device ACC PAa MDR C I, FDA C II 6
Witham et al.110 82 GBR OBS Stayhealthy Inc. RT3 Hip-worn ACC PA - 6
Young et al.113 100 USA OBS Actigraph wGT3X-BT Hip-worn ACC PAa MDR C I, FDA C II 6
Alvarez-Garcia et al.19 100 USA RCT ReDS™ Wearable System Vest B-IMP CONG FDA C II 6
Amir et al.20 50 ISR OBS ReDS™ Wearable System Vest B-IMP CONG FDA C II 6
Bensimhon et al. 22 108 USA PT ReDS™ Wearable System Vest B-IMP CONG FDA C II 6
Curtain et al.29 66 GBR OBS Sensinel CPM System by Analog Devices, Inc. Patches B-IMP CONG - 6
Lala et al.68 220 USA OBS ReDS™ Wearable System Vest B-IMP CONG FDA C II 6
Polcz et al.84 155 USA OBS ZOE® vest B-IMP CONG - 6
Ueno et al.103 12 JPN OBS ReDS™ Wearable System Vest B-IMP CONG FDA C II 6
Aamodt et al.15 10 NOR OBS CardioSet Edema Guard Monitor Vest B-IMP CONG - 6
Guo et al.49 66 CHN OBS BECG1200A, Thoth Medical Technology Co Patch ECG HR - 6
Kikuchi et al.64 10 JPN OBS hitoe®, TORAY Vest ECG HR, Rhythm - 5
Dagan et al.31 29 ISR OBS BB-613WP Wrist-worn device PPG HR, SpO2, Respiratory Rate, PTT - 6
Lin et al.72 40 TWN POC Prototype of Smart Clothes Wrist-worn device SCG Cardiac Time Intervals - 4
Combined measurement techniques
Yates et al.112 29 USA OBS Actiheart, Camntech limited Wrist-worn device ACC, ECG PAa FDA C II 7
Smeets et al.98 36 BEL OBS Wearable Bioimpedance Monitor (IMEC) Vest ACC, ECG, B-IMP CONG - 5
Stehlik et al.102 100 USA OBS VitalPatch® RTM (VitalConnect®) Patch ACC, ECG, B-IMP, Thermometer PA, HRa, HRV, RR interval, Skin humidity FDA C II Insufficient information
Kovisto et al.67 20 FIN POC Custom-build multi-sensor device Multi-sensor device ACC, ECG, SCG HR, Rhythm, CAB - All: 3
Blockhaus et al.23 140 DEU OBS WCD ZOLL LifeVest® Vest ACC, ECG, SCG PA FDA C III 6
Burch et al.26 197 USA RCT WCD ZOLL LifeVest® Vest ACC, ECG, SCG PA, HRa FDA C III PA:6, HR: 9
Burkhoff et al.27 1066 USA OBS WCD ZOLL LifeVest® Vest ACC, ECG, SCG HRa, CAB FDA C III HR: 9, CAB: 5
Erath et al.40 671 USA OBS WCD ZOLL LifeVest® Vest ACC, ECG, SCG HRa, Rhythma, CAB FDA C III HR, Rhythm: 9; CAB: 5
Garcia et al.45 1013 FRA OBS WCD ZOLL LifeVest® Vest ACC, ECG, SCG HRa FDA C III 9
Hillmann et al.51 276 DEU OBS WCD ZOLL LifeVest® Vest ACC, ECG, SCG PA, HRa FDA C III PA:6, HR: 9
Iliodromitis et al.54 77 DEU OBS WCD ZOLL LifeVest® Vest ACC, ECG, SCG PA FDA C III 6
Jungbauer et al.62 1353 DEU OBS WCD ZOLL LifeVest® Vest ACC, ECG, SCG HRa FDA C III 9
Röger et al.88 105 DEU OBS WCD ZOLL LifeVest® Vest ACC, ECG, SCG HRa FDA C III 9
Mlakar et al.77 24 SVN OBS prototype of multi- sensor wearable Multi-sensor device ACC, ECG, Thermometer PA, HR, Rhythm, EE, Temperature, skin-humidity - Insufficient information
Solar et al.101 NA ESP POC Wearable platform Body- and hip-worn ACC, ECG, Thermometer, Humidity sensor PA, HR, HRV, Temperature, Skin humidity, Potassium, EE - 4
Deka et al.33 30 USA OBS Fitbit Charge HR Wrist-worn device ACC, PPG PA, HRa MDR C IIa, FDA C II PA: 6 HR: 7
Dorsch et al.38 83 USA RCT Fitbit Charge 2 Wrist-worn device ACC, PPG PA, HRa MDR C IIa, FDA C II All functions: 6
Gardner et al.46 39 USA OBS Nonin WristOx2 model 3150, Actisleep+ Wrist-worn device ACC, PPG PAa, Sleep, SpO2a ActiGraph: FDA CII, MDR C I; Nonin: FDA C II All functions: 5
Herkert et al.50 19 NLD OBS Fitbit Charge 2 & Mio Slice Wrist-worn device ACC, PPG PA, HRa, EE Fitbit: MDR C IIa, FDA C II Fitbit: PA: 6, HR: 6, EE: 5; MioSlice: PA: 6, HR: 6, EE: 5
Nagatomi et al.78 30 JPN RCT Fitbit Inspire HR Wrist-worn device ACC, PPG PA, HRa MDR C IIa, FDA C II PA: 6 HR: 6
Sohn et al.100 20 USA OBS Fitbit Charge 2 Wrist-worn device ACC, PPG PA MDR C IIa, FDA C II 6
Vetrovsky et al.108 29 CZE OBS Withings Go, Fitbit Charge 2, Garmin vivofit, Garmin vivofit 3, Omron HJ-322U-E, smartLAB walk+ Wrist-worn device ACC, PPG PA Fitbit: MDR C IIa, FDA C II All devices: 6
Iqbal et al.57 NA USA POC Custom-built wearable belt Hip-worn ACC, PPG, ECG, B-IMP PA, HR, Sleep, Rhythm - All functions: 4
Iqbal et al.56 10 USA POC Custom-built wearable belt Hip-worn ACC, PPG, ECG, B-IMP PA, HR, Sleep, Rhythm - All functions: 5
Wong et al.111 20 CHN OBS Biofourmis Everion Armband ACC, PPG, ECG, Thermometer, Barometer PA, HR, HRV, Temperature, Blood pulse wave, SpO2, Respiratory Rate - Insufficient information
Darling et al.32 106 USA OBS Philips fluid accumulation vest Vest B-IMP, ECG CONG - 6
Pan et al.83 37 USA OBS Philips fluid accumulation vest Vest B-IMP, ECG CONG - 5
Sanchez-Perez et al.90 24 USA POC Multimodal sensing system Multi-sensor device B-IMP, microphone CONG, Rhythm - All functions: 5
Li et al.70 76 CHN OBS WENXIN® device Patch ECG, Microphone Rhythm, CAB - All functions: 5
Inan et al.55 45 USA OBS Prototype sensing patch Patch ECG, SCG HF status (compensated vs. decompensated) - 4
Shandhi et al.94 59 USA OBS Custom-built wearable patch Patch ECG, SCG VO2 - 5
Kaneko et al.63 49 JPN OBS AUDICOR AM-RT Patch PPG, ECG CONG, HR, CAB - All functions: 6
Di Rienzo et al.34 NA ITA POC SeisMote Vest PPG, ECG, SCG HR, HRV, PTT - All functions: 4
Savoldelli et al.91 15 ITA POC Hodwy Senior of Comftech© Vest PPG, ECG, Thermometer HR, Rhythm, Temperature - All functions: 5

NOR Norway, USA United States of America, ISR Israel, SWE Sweden, DEU Germany, AUT Austria, BRA Brazil, ITA Italy, GBR United Kingdom, NLD The Netherlands, FRA France, CHN China, JPN Japan, FIN Finland, TWN Taiwan, SVN Slovenia, DNK Denmark, PRT Portugal, CZE Czech Republic, OBS Observational study, RCT Randomized controlled trial, POC Proof-of-concept, PT Pilot trial, ACC Accelerometry, B-IMP Bio-impedance, ECG Electrocardiography, SCG Seismocardiography, PPG Photoplethysmography, PA Physical activity, HR Heart rate, HRV Heart rate variability, PTT Pulse transit time, EE Energy expenditure, CONG Pulmonary Congestion, (C)HF (Chronic) heart failure, MDR Medical device regulations, FDA Food and drug administration.

aThese functions are medical graded.

bThese studies are sub-studies of randomized controlled trials in which a wearable is used as measuring device in both the intervention and the control arm.