[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658420":3},{"organization":4,"outcomesModule":7,"designInfo":104,"detailedDescription":103,"studyPopulation":103,"armGroups":112,"interventions":124,"overallOfficials":129,"centralContacts":133,"locations":142,"responsibleParty":159,"collaborators":103,"id":161,"slug":162,"hasResults":163,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":103,"eligibilityCriteria":167,"healthyVolunteers":163,"sex":168,"minAge":169,"maxAge":170,"enrollmentInfo":171,"targetDuration":103,"studyType":174,"phases":175,"briefSummary":177,"conditions":178,"keywords":181,"overallStatus":187,"whyStopped":103,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},{"fullName":5,"class":6},"University of Ottawa","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":103},[9],{"measure":10,"description":11,"timeFrame":12},"Core temperature (Peak)","Peak rectal temperature (15 min average) during exposure. Rectal temperature is measured continuously throughout the simulated indoor overheating exposure.","End of 8-hour exposure",[14,18,21,24,27,30,33,36,39,42,45,48,51,54,57,60,63,66,69,72,75,78,81,84,87,90,94,97,100],{"measure":15,"description":16,"timeFrame":17},"Profiles of Mood States (POMS)","Potential changes in mood (7 subscales of mood: tension, anger, depression, fatigue, confusion, vigor and esteem-related affect). The POMS-40 is a validated, self-administered questionnaire that examines seven distinct aspects of mood state across two positive subscales (Esteem-Related Affect, and Vigor) and five negative subscales (Fatigue, Tension, Confusion, Anger, and Depression), which are described across 40 distinct adjectives. For each individual item, participants were asked to describe \"how you feel right now\" by responding using a 5-point Likert scale (0 = \"Not at all\", 1 = \"A little\", 2 = \"Moderately\", 3 = \"Quite a lot\", or 4 = \"Extremely\"). The values of items associated with a specific subscale (e.g., Fatigue) were summed to calculate its score.","At the start (hour 0) and end of exposure (hour 8)",{"measure":19,"description":20,"timeFrame":17},"Environmental Symptoms Questionnaire (ESQ)","Self-reported environmental reactions and medical symptomatology associated with prolonged heat exposure. The ESQ-IV is a validated 68-item, self-administered questionnaire that has been used successfully in identifying symptomatology during exposure to a wide variety of environmental conditions, including heat exposure \\[24, 25\\]. Participants are asked to assess and described \"how you have been feeling today\" by responding to each item using a 6-point Likert scale (0 = \"Not at all\", 1 = \"Slight\", 2 = \"Somewhat\", 3 = \"Moderate\", 4 = \"Quite a bit\", or 5 = \"Extreme\"). Total Symptom Score was calculated from this data by taking the sum of the intensity ratings from all 68 individual items using reverse scores for the three positive items from the list (\"I Felt Good\", \"I Felt Alert\", and \"I Felt Wide Awake\").",{"measure":22,"description":23,"timeFrame":17},"Orthostatic intolerance symptoms assessment","Cumulative sum of scores on 6 questions asking participant to rank symptoms associated with orthostatic intolerance during the lying to standing tests. All symptoms scored on a scale from 0 (none) to 10 (worst possible) and include feelings of: (1) \"dizziness, lightheadedness, feeling faint, or feeling like you might black out\"; (2) \"Problems with vision (blurring, seeing spots, tunnel vision, etc.)\"; (3) \"Weakness\"; (4) \"Fatigue\"; (5) \"Trouble concentrating\"; and (6) \"Head and neck discomfort\".",{"measure":25,"description":26,"timeFrame":12},"Perceived arousal (Felt Arousal Scale)","Perceived arousal assessed using the Felt Arousal Scale, a single-item 6-point numerical rating scale on which participants respond to the question \"How worked up are you?\" Scores range from a minimum of 1 (low arousal) to a maximum of 6 (high arousal).",{"measure":28,"description":29,"timeFrame":12},"Perceived thirst (Thirst Sensation Scale)","Perceived thirst assessed using the Thirst Sensation Scale, a single-item 9-point numerical rating scale on which participants respond to the question \"How thirsty do you feel now?\" Scores range from a minimum of 1 to a maximum of 9, with verbal anchors at 1 (not thirsty at all), 3 (a little thirsty), 5 (moderately thirsty), 7 (very thirsty), and 9 (very, very thirsty).",{"measure":31,"description":32,"timeFrame":12},"Thermal sensation (American Society of Heating, Refrigerating and Air-Conditioning Engineers thermal sensation scale)","Thermal sensation assessed using the thermal sensation scale defined in ANSI\u002FASHRAE Standard 55 (American Society of Heating, Refrigerating and Air-Conditioning Engineers), a single-item 7-point bipolar rating scale on which participants respond to the question \"How do you feel right now?\" Scores range from a minimum of -3 (cold) to a maximum of +3 (hot), with 0 indicating a neutral thermal sensation.",{"measure":34,"description":35,"timeFrame":12},"Thermal comfort (American Society of Heating, Refrigerating and Air-Conditioning Engineers thermal comfort scale)","Thermal comfort assessed using the thermal comfort scale defined in ANSI\u002FASHRAE Standard 55 (American Society of Heating, Refrigerating and Air-Conditioning Engineers), a single-item 4-point rating scale on which participants respond to the question \"How comfortable do you feel right now?\" Scores range from a minimum of 1 (comfortable) to a maximum of 4 (very uncomfortable).",{"measure":37,"description":38,"timeFrame":12},"Change in plasma volume","Change in plasma volume from baseline values calculated from duplicate measurements of hemoglobin and hematocrit at the start and end of each exposure using the technique by Dill and Costill",{"measure":40,"description":41,"timeFrame":12},"Fluid loss","Fluid loss calculated as the change in body mass during each exposure presented as a percentage of baseline body mass (corrected for food consumption)",{"measure":43,"description":44,"timeFrame":12},"Fluid consumption","Average hourly fluid consumption calculated by weighing participant water intake at the start and end of each hour of exposure (normalized to the exposure duration).",{"measure":46,"description":47,"timeFrame":17},"Heart rate variability: RMSSD","Root mean squared standard deviation of normal-to-normal R-wave to R-wave intervals (RMSSD) measured during 5 minutes of paced breathing (15 breaths\u002Fmin) with participants in the seated position. RMSSD will be evaluated twice, during two paced breathing periods (separated by 4 min of seated rest).",{"measure":49,"description":50,"timeFrame":17},"Heart rate variability: SDNN","Standard deviation of normal-to-normal R-wave to R-wave intervals (SDNN) measured during 5 minutes of paced breathing (15 breaths\u002Fmin) with participants in the seated position. SDNN will be evaluated twice, during two paced breathing periods (separated by 4 min of seated rest).",{"measure":52,"description":53,"timeFrame":12},"Rate pressure product","Rate pressure product, an index of myocardial work and strain, calculated as systolic blood pressure x heart rate.",{"measure":55,"description":56,"timeFrame":12},"Diastolic blood pressure","Diastolic blood pressure measured in triplicate via automated oscillometry (\\~60 seconds between measures)",{"measure":58,"description":59,"timeFrame":12},"Systolic blood pressure","Systolic blood pressure measured in triplicate via automated oscillometry (\\~60 seconds between measures)",{"measure":61,"description":62,"timeFrame":17},"Systolic Response to Standing From Supine","Systolic blood pressure response to standing evaluated as the difference in blood pressure measured between the standing and supine. Standing systolic blood pressure will be taken as the lowest value of those measured after 60 and 120 seconds of standing. Systolic response to standing will be evaluated twice, during two lying-to-standing tests (separated by 10 min of supine rest).",{"measure":64,"description":65,"timeFrame":17},"CDC 4-Stage Balance Test (Postural stability)","To assess postural stability, participants hold a tablet to their chest, then auditory cues guide participants through four consecutive stances, feet side by side, instep of one foot touching the big toe of the other foot, tandem stand with one foot in front of the other, heel touching toe, and stand on one foot. The balance assessment will be evaluated based on movement detected by an accelerometer integrated into the hardware of the tablet device (Sway Medical Inc).",{"measure":67,"description":68,"timeFrame":17},"Executive function (cognitive function)","Participants will be provided with a tablet device with the Sway Medical testing platform for the assessment of executive function. Participants will complete the Cued Stroop test, in which they are presented a sequence of congruent, neutral and incongruent colour-word tasks.",{"measure":70,"description":71,"timeFrame":17},"Memory recall (cognitive function)","Participants will be provided with a tablet device with the Sway Medical testing platform for the assessment of memory recall. Participants complete both a delayed recall test and a working memory test.",{"measure":73,"description":74,"timeFrame":17},"Impulse control (cognitive function)","Participants will be provided with a tablet device with the Sway Medical testing platform for the assessment of impulse control. Participants will be asked to respond to both \"go\" and \"no-go\" visual cues. In response to the \"go\" cue, participants will initiate a movement of the device.",{"measure":76,"description":77,"timeFrame":17},"Reaction time (cognitive function)","Participants will be provided with a tablet device with the Sway Medical testing platform for the assessment of reaction time. Participants will be asked to initiate a movement of the device in response to a visual cue.",{"measure":79,"description":80,"timeFrame":17},"Cardiac response to standing from supine (30:15 Ratio)","Cardiac response to standing evaluated as the ratio between the highest R-wave to R-wave interval (lowest heart rate) measured at the 30th heart beat after standing from supine (+\u002F- 5 beats) and the lowest R-wave to R-wave interval (highest heart rate) measured at the 15th heart beat after standing (+\u002F- 5 beats). Cardiac response to standing will be evaluated twice, during two lying-to-standing tests (separated by 10 min of supine rest). Assessment is performed in the morning prior to and following daytime exposure.",{"measure":82,"description":83,"timeFrame":12},"Heart rate (AUC)","Area under the curve of heart rate (in bpm-hours)",{"measure":85,"description":86,"timeFrame":12},"Heart rate (Peak)","Peak Heart rate (15-min average) during the 8-hour exposure",{"measure":88,"description":89,"timeFrame":12},"Core temperature (AUC)","Area under the curve of rectal temperature (in degree-hours)",{"measure":91,"description":92,"timeFrame":93},"Core temperature (hourly)","Rectal temperature measured at each hour of exposure (15-min average)","Hourly during the 8-hour exposure",{"measure":95,"description":96,"timeFrame":12},"Mean skin temperature (Peak)","Peak mean skin temperature (15-min average) during the 8-hour exposure",{"measure":98,"description":99,"timeFrame":12},"Mean skin temperature (AUC)","Area under the curve of mean skin temperature (in degree-hours)",{"measure":101,"description":102,"timeFrame":17},"Urine specific gravity","Urine specific gravity measured by handheld refractometer",null,{"allocation":105,"interventionModel":106,"interventionModelDescription":103,"primaryPurpose":107,"observationalModel":103,"timePerspective":103,"maskingInfo":108},"RANDOMIZED","CROSSOVER","BASIC_SCIENCE",{"masking":109,"maskingDescription":103,"whoMasked":110},"SINGLE",[111],"OUTCOMES_ASSESSOR",[113,119],{"label":114,"type":115,"description":116,"interventionNames":117},"Recommended indoor temperature limit (26 °C)","ACTIVE_COMPARATOR","Eight-hour passive seated exposure to an indoor environment maintained at 26 °C and 45% relative humidity, corresponding to the recommended upper indoor temperature limit for heat-susceptible occupants.",[118],"Other: Simulated indoor thermal environment",{"label":120,"type":121,"description":122,"interventionNames":123},"Indoor overheating (36 °C)","EXPERIMENTAL","Eight-hour passive seated exposure to an indoor environment maintained at 36 °C and 45% relative humidity, representing warm indoor conditions recorded inside Canadian dwellings without mechanical cooling during heat events.",[118],[125],{"type":6,"name":126,"description":127,"armGroupLabels":128,"otherNames":103},"Simulated indoor thermal environment","Day-long (8 h) passive exposure in a climate-controlled environmental chamber at a set air temperature and relative humidity. Participants remain seated or resting.",[120,114],[130],{"name":131,"affiliation":5,"role":132},"Glen P Kenny, PhD","STUDY_DIRECTOR",[134,139],{"name":135,"role":136,"phone":137,"phoneExt":103,"email":138},"Nicholas Goulet, MSc","CONTACT","613-322-9930","ngoul043@uottawa.ca",{"name":140,"role":136,"phone":103,"phoneExt":103,"email":141},"Pascal Imbeault, PhD","imbeault@uottawa.ca",[143],{"facility":5,"status":103,"city":144,"state":145,"zip":146,"country":147,"countryCode":148,"cosmosGeoPoint":149,"geoPoint":154,"contacts":155},"Ottawa","Ontario","K1N 6N5","Canada","CA",{"type":150,"coordinates":151},"Point",[152,153],-75.69812,45.41117,{"lat":153,"lon":152},[156,157],{"name":135,"role":136,"phone":137,"phoneExt":103,"email":138},{"name":131,"role":136,"phone":103,"phoneExt":103,"email":158},"gkenny@uottawa.ca",{"type":160,"investigatorFullName":103,"investigatorTitle":103,"investigatorAffiliation":103,"oldNameTitle":103,"oldOrganization":103},"SPONSOR","100658420","indoor-overheating-and-physiological-strain-in-older-adults-with-copd-100658420",false,"NCT07852910","Indoor Overheating and Physiological Strain in Older Adults With COPD","The Impact of Extreme Heat on Individuals Living With Chronic Obstructive Pulmonary Disease: A Randomized Crossover Trial of Day-Long Passive Indoor Heat Exposure","Inclusion Criteria:\n\n* Aged 60 to 80 years\n* Physician diagnosis of chronic obstructive pulmonary disease made at least 5 years previously\n* Clinically stable, with no acute exacerbation or active respiratory infection in the preceding 6 weeks\n* Current non-smoker\n* Able to communicate in English or French and to provide written informed consent\n\nExclusion Criteria:\n\n* Physical restriction preventing safe participation, including unstable cardiac or pulmonary disease, uncontrolled hypertension (resting blood pressure exceeding 150\u002F95 mmHg), severe arthritis, renal impairment, active proliferative retinopathy, history of disabling stroke, or intermittent claudication\n* Recent change in medications judged by the investigators to make participation inadvisable\n* Cardiac abnormalities identified on electrocardiogram during the screening exercise test\n* Regular work or exercise in hot environments (heat acclimatized)","ALL","60 Years","80 Years",{"count":172,"type":173},18,"ESTIMATED","INTERVENTIONAL",[176],"NA","During warm weather, homes without air conditioning can stay hot for long periods, and most heat-related health problems in Canada happen indoors rather than outdoors. Health Canada recommends that indoor temperatures not exceed 26 °C in homes occupied by people who are more susceptible to heat. That recommendation is based largely on population-level evidence, and very little is known about how susceptible individuals actually respond, physiologically, when indoor temperatures rise above it.\n\nOlder adults living with chronic obstructive pulmonary disease (COPD) are among the groups identified as more susceptible to heat. COPD involves persistent airflow limitation, reduced lung and cardiovascular reserve, and altered cellular stress responses. Despite this, no laboratory study has directly measured how adults with COPD respond to a full day spent indoors in warm conditions.\n\nThis randomized crossover trial will measure how older adults with COPD respond to two different indoor environments, each experienced for eight hours on separate days at least one week apart. One day is spent at the recommended indoor temperature limit and the other at a warmer temperature representative of conditions recorded inside Canadian homes during hot weather. Participants remain seated and rest throughout; no exercise or work is performed.\n\nThroughout each day, the research team continuously measures core body temperature, skin temperature, heart rate, and measures blood pressure, lung function, breathlessness, thermal comfort, cognitive performance, and balance at set time points. Blood and urine samples are collected at the start and end of each day. Participants are monitored continuously by trained staff.\n\nThe results are intended to strengthen the evidence base behind Canadian indoor temperature guidance and to inform recommendations for protecting people living with chronic lung disease during hot weather.",[179,180],"Chronic Obstructive Pulmonary Disease (COPD)","Heat Stress",[182,183,184,185,186],"indoor overheating","extreme heat","thermoregulation","core temperature","pulmonary function","NOT_YET_RECRUITING","2026-10-01",{"date":190,"type":191},"2026-10-05","ACTUAL",{"date":193,"type":173},"2026-10-13",{"date":195,"type":173},"2027-05-31",{"name":5,"class":6},1]