- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02825303
Mid-term Effect of a Novel Sit-to-stand Workplace (ACTIVE OFFICE) on Cognitive and Physiological Parameters
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Measurements were made both in the field and in a laboratory. Field measurements were made and processed continuously over the 23-week intervention period. Laboratory measurements were made on two different days, one day prior to intervention, and one day following intervention (due to cross-over design, each subject underwent 4 total days of laboratory measurements). Field measurements were collected automatically at the participants' workstation in their working office.
Laboratory tests were conducted in a controlled, simulated work-space located at the University of Applied Sciences Campus Linz. All laboratory measurements were made in a controlled laboratory at the campus site Linz of the University of Applied Sciences Upper Austria. Temperature, air flow, humidity, lighting conditions (artificial light only) and noise level were controlled and set to be consistent with the subjects' typical working environment.
During the laboratory measurements, subjects either stood or sat upright in an ergonomic office chair, according to the study protocol. Subjects were encouraged to work as fast and as accurately as they could. To ensure identical testing conditions between subjects and to not unduly influence physiological parameters such as salivary cortisol level or heart rate variability, subjects were required to minimize excessive movement (e.g. standing up during the sitting periods).
In the first (initial) phase, participants were familiarized with the study protocol. Sitting time and weekly physical activity were determined via the IPAQ-questionnaire. Examples of each cognitive test implemented in the cognitive phase were executed according to their guidelines. A 30 minute break in a sitting posture was used to ascertain baseline heart-rate and cortisol level. Baseline heart-rate was calculated after a 20 minute rest for a 5 minute interval and saliva samples were collected at the end (30min) of the break.
In the second (cognitive) phase subjects participated in a test battery containing five blocks. Each block consisted of a working speed test (text editing task), an attentional test (d2R-test of attention) and a reaction time test (Stroop-test). These tests lasted for 30 minutes to fulfill recommendations regarding postural changes. To simulate "common" working conditions (computer based and non-computer based tasks), digital (text editing task, Stroop-test) as well as pen & paper (d2R-test) versions of the implemented tests were used. All blocks were executed in alternating postures (sit - stand - sit - stand - sit) and at the end of each block - after a 5 minute break - salivary samples were collected. The order of posture was not changed within groups or time.
In the third (final) phase participants were asked to estimate their workload by means of the NASA-TLX questionnaire followed by a 30 minute resting phase in a sitting posture. During both 30 min resting phases (initial & final) participants watched documentaries and were encouraged not to talk.
Salivary samples were collected after each break during the study protocol and on the following morning, 20 minutes after waking up, to ascertain cortisol awakening response (CAR). Salivary samples were centrifuged and stored at -80 °C for subsequent testing using a chemiluminescent immunoassay.
Heart-rate and trunk movements were measured from the start of the study protocol until the CAR measurement.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Upper Austria
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Linz, Upper Austria, L'Autriche, 4020
- University of Applied Sciences Upper Austria
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Healthy Caucasian (no acute or chronic diseases)
- Normal weight or slightly overweight (BMI: 18.5 - 27.5 kg/m²)
- Regularly working in sedentary office environments
- Regular computer users
- Fluent German speakers
- Consented to participate
Exclusion Criteria:
- Heavily overweight & Obesity (BMI > 27.5 kg/m²)
- Short office stay duration (< 8 h / day or < 20 h / week)
- Experience in sit-to-stand workstations
- Acute or chronic diseases
- Inability to stand
- Visual impairments that had not been corrected
- Color blindness
- People planning to change their physical activity level
- Regular smokers (> 1 cigarette /day)
- Not consented to participate
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Novel workplace - first half
Intervention: A novel two-desk sit-to-stand workstation for 23 weeks; provided within the first half of the study.
Traditional workstation within the second half of the study.
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Desk arrangements: self-determined by the participants Desk equipment: depending on pre-intervention condition - 1 or 2 screens per desk Build-up: one day prior to the intervention period at the location of the workplace Adjustment: together with the study leader
|
Expérimental: Novel workplace - second half
Intervention: A novel two-desk sit-to-stand workstation for 23 weeks; provided within the second half of the study.
Traditional workstation within the frist half of the study.
|
Desk arrangements: self-determined by the participants Desk equipment: depending on pre-intervention condition - 1 or 2 screens per desk Build-up: one day prior to the intervention period at the location of the workplace Adjustment: together with the study leader
|
Aucune intervention: Control group
Control group subjects did not encounter any changes in their regular office environments.
Traditional workstation for both halves of the study.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Daily sitting time
Délai: baseline and 23 weeks
|
Changes in sitting time after 23 weeks in the experimental group compared with its own control period and the control group.
Measuring methods: International Physical Activity Questionaire (IPAQ); self developed tracking software at the participants' workplace
|
baseline and 23 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Cognitive performance (composite outcome)
Délai: baseline and 23 weeks
|
Changes in cognitive performance after 23 weeks in the experimental group compared with its own control period and the control group.
Measuring methods: Digital color-word-conflict stroop test, d2R-test of attention, text editing task, NASA-TLX
|
baseline and 23 weeks
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Stress response
Délai: baseline and 23 weeks
|
Changes in stress response after 23 weeks in the experimental group compared with its own control period and the control group.
Measuring methods: Heart rate variability (HRV), salivary cortisol ELISA
|
baseline and 23 weeks
|
Collaborateurs et enquêteurs
Collaborateurs
Publications et liens utiles
Publications générales
- Owen N, Sparling PB, Healy GN, Dunstan DW, Matthews CE. Sedentary behavior: emerging evidence for a new health risk. Mayo Clin Proc. 2010 Dec;85(12):1138-41. doi: 10.4065/mcp.2010.0444. No abstract available.
- Bates ME, Lemay EP Jr. The d2 Test of attention: construct validity and extensions in scoring techniques. J Int Neuropsychol Soc. 2004 May;10(3):392-400. doi: 10.1017/S135561770410307X.
- Commissaris DA, Konemann R, Hiemstra-van Mastrigt S, Burford EM, Botter J, Douwes M, Ellegast RP. Effects of a standing and three dynamic workstations on computer task performance and cognitive function tests. Appl Ergon. 2014 Nov;45(6):1570-8. doi: 10.1016/j.apergo.2014.05.003. Epub 2014 Jun 17.
- Neuhaus M, Healy GN, Dunstan DW, Owen N, Eakin EG. Workplace sitting and height-adjustable workstations: a randomized controlled trial. Am J Prev Med. 2014 Jan;46(1):30-40. doi: 10.1016/j.amepre.2013.09.009.
- Van der Elst W, Van Boxtel MP, Van Breukelen GJ, Jolles J. The Stroop color-word test: influence of age, sex, and education; and normative data for a large sample across the adult age range. Assessment. 2006 Mar;13(1):62-79. doi: 10.1177/1073191105283427.
- Best JR, Nagamatsu LS, Liu-Ambrose T. Improvements to executive function during exercise training predict maintenance of physical activity over the following year. Front Hum Neurosci. 2014 May 27;8:353. doi: 10.3389/fnhum.2014.00353. eCollection 2014.
- Hennig J, Friebe J, Ryl I, Kramer B, Bottcher J, Netter P. Upright posture influences salivary cortisol. Psychoneuroendocrinology. 2000 Jan;25(1):69-83. doi: 10.1016/s0306-4530(99)00037-2.
- Lynch BM. Sedentary behavior and cancer: a systematic review of the literature and proposed biological mechanisms. Cancer Epidemiol Biomarkers Prev. 2010 Nov;19(11):2691-709. doi: 10.1158/1055-9965.EPI-10-0815. Epub 2010 Sep 10.
- Brown WJ, Miller YD, Miller R. Sitting time and work patterns as indicators of overweight and obesity in Australian adults. Int J Obes Relat Metab Disord. 2003 Nov;27(11):1340-6. doi: 10.1038/sj.ijo.0802426.
- Schwartz B, Kapellusch JM, Baca A, Wessner B. Medium-term effects of a two-desk sit/stand workstation on cognitive performance and workload for healthy people performing sedentary work: a secondary analysis of a randomised controlled trial. Ergonomics. 2019 Jun;62(6):794-810. doi: 10.1080/00140139.2019.1577497. Epub 2019 Apr 7.
- Schwartz B, Kapellusch JM, Schrempf A, Probst K, Haller M, Baca A. Effect of a novel two-desk sit-to-stand workplace (ACTIVE OFFICE) on sitting time, performance and physiological parameters: protocol for a randomized control trial. BMC Public Health. 2016 Jul 15;16:578. doi: 10.1186/s12889-016-3271-y.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- AO-8735-1
- 834185 (Autre subvention/numéro de financement: Austrian Research Promotion Agency (FFG))
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
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