Trial Summary
What is the purpose of this trial?
This study evaluates critical environmental limits (temperature and humidity) above which older adults are unable to effectively thermoregulate. Participants will exercise in a series of different environmental conditions to identify combinations of temperature and humidity above which age-related physiological changes cause uncompensable heat stress, resulting in increased risk of heat illness.
Do I need to stop my current medications for the trial?
You may need to stop taking medications that affect thermoregulatory or cardiovascular responses to exercise, as these are part of the exclusion criteria.
What data supports the idea that Thermal Tolerance Assessment for Aging Adults is an effective treatment?
The available research does not provide specific data supporting the effectiveness of Thermal Tolerance Assessment for Aging Adults as a treatment. Instead, the studies focus on the placebo effect and its impact on clinical trials, suggesting that patient expectations can influence perceived effectiveness. This means that the belief in receiving an active treatment can lead to improved outcomes, even if the treatment itself is not directly effective. Therefore, while the research highlights the importance of managing expectations in trials, it does not offer direct evidence of the treatment's effectiveness for its intended use.12345
What safety data exists for the treatment involving aspirin or similar substances?
The provided research does not contain specific safety data for aspirin or its variants (such as Low dose ASA, Acetylsalicylic acid) in the context of thermal tolerance assessment for aging adults. The studies focus on other substances like TRPV1 antagonist, celecoxib, capsaicin, and indomethacin, none of which directly relate to aspirin or its safety profile in this context.678910
Is the treatment 'Control' (Placebo, Standard Care) promising for helping older adults with thermal tolerance?
The treatment 'Control' (Placebo, Standard Care) is promising because it helps us understand how older adults respond to temperature changes. This understanding can lead to better ways to improve their comfort and sleep quality, as older adults often have reduced sensitivity to temperature changes, which can affect their sleep and overall well-being.1112131415
Research Team
WL
W. Larry Kenney, Ph.D.
Principal Investigator
The Pennsylvania State University
Eligibility Criteria
This trial is for adults aged 18 and older, with a focus on those who are healthy and show no signs of disease. Women must have regular menstrual cycles. Participants over 40 need doctor approval. Excluded are those on certain meds, with exercise restrictions, pregnant women, or with a history of serious diseases like cancer or diabetes.Inclusion Criteria
I feel fine and show no signs of my condition according to exercise guidelines.
I am a premenopausal woman with regular menstrual cycles.
I am 18 or older. If I'm 40+, a doctor has approved my participation.
Exclusion Criteria
I am not on medications that affect my body's response to heat or exercise.
I have a history of Crohn's disease, diverticulitis, or a similar gut condition.
Any contraindications to low intensity physical activity on the Physical Activity Readiness Questionnaire
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Treatment Details
Interventions
- Control (Other)
- Low dose ASA (Other)
Trial OverviewThe study tests how well older adults can handle heat by having them exercise in various temperatures and humidity levels. The goal is to find the environmental limits where aging bodies struggle to regulate temperature, increasing the risk of heat-related illnesses.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Critical Environmental LimitsExperimental Treatment1 Intervention
Subjects will perform exercise at \~200-300W with ambient temperature or humidity increasing every 5 min throughout the trial until core temperature begins to rise.
Group II: Aspirin SupplementationExperimental Treatment1 Intervention
After a minimum of 7 days of daily, low-dose aspirin ingestion, older subjects will repeat critical environmental limits trials. As before, subjects will perform exercise at \~200-300W with ambient temperature or humidity increasing every 5 min throughout the trial until core temperature begins to rise.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Noll LaboratoryUniversity Park, PA
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Who Is Running the Clinical Trial?
Penn State University
Lead Sponsor
Trials
380
Patients Recruited
131,000+
References
The hidden effects of blinded, placebo-controlled randomized trials: an experimental investigation. [2021]The knowledge of having only a 50% chance of receiving an active drug can result in reduced efficacy in blinded randomized clinical trials (RCTs) compared to clinical practice (reduced external validity). Moreover, minor onset sensations associated with the drug (but not with an inert placebo) can further challenge the attribution of group differences to drug-specific efficacy (internal validity). We used a randomized experimental study with inert placebos (inert substance) vs active placebos (inducing minor sensations), and different instructions about group allocation (probability of receiving drug: 0%, 50%, 100%). One hundred forty-four healthy volunteers were informed that a new application method for a well-known painkiller would be tested. Pain thresholds were assessed before and after receiving nasal spray. Half of the nasal sprays were inert placebos (sesame oil), while the other half were active placebos inducing prickling nasal sensations (sesame oil with 0.014% capsaicin). The major outcome was pain threshold after placebo application. A substantial expectation effect was found for the inert placebo condition, with participants who believed they had received an active drug reporting the highest pain thresholds. Active placebos show substantial differences to passive placebos in the 50% chance group. Therefore, patient expectations are significantly different in placebo-controlled clinical trials (50% chance) vs clinical practice (100% chance). Moreover, minor drug onset sensations can challenge internal validity. Effect sizes for these mechanisms are medium, and can substantially compete with specific drug effects. For clinical trials, new study designs are needed that better control for these effects.
Nocebo vs. placebo: the challenges of trial design in analgesia research. [2015]The placebo effect in randomized clinical trials appears to have increased thereby contributing to problems of demonstrating statistically reliable effects of treatments that directly target biological mechanisms. The shortcomings of randomized clinical trials are currently discussed along with potential improvements of trial designs. In this review we explain how utilizing knowledge from the placebo and nocebo mechanisms literature could improve the information that can be obtained from randomized clinical trials. We present three major challenges in randomized clinical trials: (i) increasing placebo effects, (ii) variability of the placebo effect, and (iii) risk of un-blinding. We then explain how recent placebo and nocebo studies of effects of verbal suggestion, expectancy, and emotions may improve understanding and discussion of increasing placebo effects, account/control for large parts of the variability of placebo effects, and suggest ways to improve blinding in future trials.
Toward rapproachment in the placebo control debate. A calculated compromise of power. [2007]In an effort to minimize risk to participants, some investigators avoid using placebo controls in randomized controlled clinical trials (RCT) if an effective treatment is available. An unintended consequence of this approach is that substantially more participants remain acutely ill (i.e., nonresponders) throughout an active-comparator trial than a placebo-controlled trial. This is due to the increased sample size required to detect smaller differences between investigational and proven active agents. The objective of this article is to identify an RCT design that will minimize both the number assigned to placebo and the number of nonresponders. To do so, two aspects of clinical trial design are manipulated: choice of comparator and treatment allocation ratio. Several examples illustrate empirically that placebo-controlled trials that are designed to randomize twice as many participants to the investigational cell could appeal to potential study participants, clinical researchers, and Institutional Review Boards alike.
What techniques might be used to harness placebo effects in non-malignant pain? A literature review and survey to develop a taxonomy. [2021]Placebo effects can be clinically meaningful but are seldom fully exploited in clinical practice. This review aimed to facilitate translational research by producing a taxonomy of techniques that could augment placebo analgesia in clinical practice.
What can be done to control the placebo response in clinical trials? A narrative review. [2023]The desire to reduce high placebo response rates in clinical trials is a popular concept. However, few studies have rigorously examined the effectiveness of methods to control for placebo responses that are relevant to randomized controlled trials. The primary objective of this review was to evaluate the effect of experimental placebo manipulations in randomized controlled trials (RCTs). We critically reviewed studies designed to manipulate placebo responses including positive expectations regarding the effectiveness of the placebo treatment, manipulating the time spent with subjects, and training study staff and subjects to accurately report symptom severity. These efforts have generally resulted in reduced placebo response and improved discrimination between drug and placebo. Interventions that neutralize staff and subject expectations and improve the ability of subjects to accurately report symptom severity have shown the most promise. Reduction of the placebo response has the potential to accelerate the development of new therapeutics.
Comparison of orofacial thermal sensitivity assessed with simple devices and sophisticated equipment. [2019]Simple thermal devices providing reliable data are needed to detect somatosensory disturbances in non-specialized clinical settings. Currently, evidence is lacking about their use. Therefore, the aim was to compare the assessment of perceived thermal sensitivity/pain in healthy humans with a state-of-the-art thermotester and with simple inexpensive customized thermal aluminium devices.
Progressive Response to Repeat Application of Capsaicin 179 mg (8% w/w) Cutaneous Patch in Peripheral Neuropathic Pain: Comprehensive New Analysis and Clinical Implications. [2021]To investigate the efficacy of repeated application of capsaicin 179 mg cutaneous patch in nonresponders to the first application.
Reliability of thermal quantitative sensory testing of the hand in a cohort of young, healthy adults. [2022]The reliability of thermal quantitative sensory testing (QST) has yet to be fully established. In this study we investigated intra- and interrater reliability of thermal QST in a blinded manner.
Indomethacin reduces the skin thermal damage in hyperthermic treatment of experimental malignant tumors. [2013]Indomethacin (Ind), an inhibitor of prostaglandin synthesis, was previously shown to increase the thermosensitivity of murine tumors. The potency of drug to modify the thermal response of murine skin has been evaluated in mice heated in water bath at 44 degrees C for 30, 60 and 90 min. Ind was administered subcutaneously (s.c.) at dose of 5 mg/kg body weight (b.w.) 1.5 h before heating. The mouse foot skin reactions (FSR) were assessed using the scoring system of Urano et al (1979). The severity of skin thermal damage was decreased markedly by Ind. At the time when heating of the control group at 44 degrees C for 60 min resulted in the irreversible FSR in some mice, pretreatment with Ind before heating lead to the complete recovery from the heat damage in all mice. Similarly, after heating at 44 degrees C for 90 min, the degree of FSR was diminished by Ind from score 4.5 to score 2. It is concluded that Ind selectively protected normal skin during the hyperthermic treatment. Further clinical study is warranted.
A randomized, double-blind, positive-controlled, 3-way cross-over human experimental pain study of a TRPV1 antagonist (V116517) in healthy volunteers and comparison with preclinical profile. [2021]This experimental, translational, experimental pain, single-center, randomized, double-blind, single-dose, 3-treatment, 3-period cross-over proof-of-concept volunteer trial studied the efficacy of a novel TRPV1 antagonist (V116517) on capsaicin- and UV-B-induced hyperalgesia. Heat and pressure pain thresholds, von Frey stimulus-response functions, and neurogenic inflammation were assessed together with safety. Each treatment period was 4 days. The 3 single oral treatments were 300 mg V116517, 400 mg celecoxib (a COX-2 inhibitor), and placebo. The heat pain detection and tolerance thresholds were increased significantly (P
Age-related decline in thermal adaptation capacities: an evoked potentials study. [2014]Aging is associated with changes in thermosensitivity and decreases in the functionality of the autonomic thermoregulation. The underlying mechanisms are, however, not fully understood. Elderly subjects may undergo functional changes in the integration process of the thermal sensory system, especially in their thermal adaptation capacities. To verify this hypothesis, we compared thermal evoked responses in younger and older subjects exposed to thermoneutral (27 °C) and warm (30 °C) environments. In the warm environment, the amplitudes of thermal evoked potentials (EPs) were significantly lower in older than in younger subjects, whereas in the thermoneutral environment, the EP amplitudes were similar in both groups. These findings suggest that thermal adaptation capacities are reduced in elderly individuals, due to a dysfunction of C-fibers with aging, particularly expressed by lowered adaptation capacities to temperature variations.
Peripheral thermal responsivity to facial cooling during sleep. [2019]A recently developed technique for examining thermal sensitivity during sleep was used to assess whether skin and core temperature responses to thermal stimulation were altered by sleep state. The technique was designed to probe thermal responsivity without altering core body temperature or inducing awakening. Twenty-seven young men and women were studied during a sleep deprivation night and a sleep night three nights later. Cold water stimulation of the face alternated with an equal period of rewarming across a 40-min cycle throughout the night. Skin temperature from the finger and rectal temperature were continuously assessed. Sleep continuity and architecture were largely uninfluenced by the thermal stimulation. Finger skin temperature decreased during cold facial stimulation in both sleep and waking states. Skin temperature changes during sleep were approximately one-fifth the magnitude of those during waking. Core temperature was minimally influenced. REM sleep was associated with a greater amplitude decrease in finger temperature than was non-REM (NREM) sleep. The results support the utility of the technique as a probe of thermal responsivity during sleep and suggest a reduction of thermal responsivity during sleep and, more tentatively, an altered responsivity during REM versus NREM sleep.
The effects of heat stress on physical functioning in persons with multiple sclerosis. [2012]Heat sensitivity is a well-recognised feature in multiple sclerosis (MS). However, little is known about how heat affects physical performance in persons with MS. The objective of the study was to evaluate the effects of short-term heat stress on physical functioning in persons with MS. Twenty-three heat-sensitive MS subjects and 19 healthy controls participated. Moderate heat exposure took place in a dry Finnish sauna. Measures of upper and lower extremity function, static and dynamic balance, and walking capacity were applied. Core body temperature was measured by a telemetric physiological monitoring system. Assessments were conducted before, immediately, 1 hour, and 1 day after the heat exposure. Subjects with MS showed a significantly (P=0.002) higher core body temperature than the controls following the heat stress. Performances in walking (P
Diminished capability to recognize the optimal temperature for sleep initiation may contribute to poor sleep in elderly people. [2022]Sleep propensity and skin temperature are functionally related. In young adults, changes of skin temperature within the comfortable thermoneutral zone affect sleep-onset latency and vigilance performance. Aging is associated with both decreased thermosensitivity and poorer sleep. Our goal was to test whether subtle manipulations of core body and skin temperature affect sleep onset in elderly people without sleep complaints and in elderly insomniacs and whether the subjective perception of these mild body temperature manipulations is preserved with aging and insomnia.
Lower thermal sensation in normothermic and mildly hyperthermic older adults. [2018]It is important to know how thermal sensation is affected by normal aging under conditions that elevate core body temperature for the prevention of heat-related illness in older people. We assessed whether thermal sensation under conditions of normothermia (NT) and mild hyperthermia (HT) is lowered in older adults.