- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05409937
Influence of Wet Clothing on Thermal Protection
연구 개요
상태
정황
상세 설명
Participants, in their first visit, will undergo baseline weighted treadmill walking consisting of ~20 min of treadmill walking with a load of 77lbs followed by ~25 min of treadmill walking with a load of 38.5lbs. They will also have their body composition evaluated (DEXA) and be fit for each uniform ensemble. This first laboratory visit will require ~3 hrs.
On separate days, participants will complete 4 experimental trials. After being submerged up to the neck in warm water for two minutes, three of the trials will ask that the participant move to a 41°F air environment, stand with minimal movement for 60 min, complete 60 min of weighted (38.5lb) treadmill walking at 2 mph, and up to 4% grade, and then complete 60 min of weighted (38.5lb) treadmill walking at 2.5 mph and up to 4% grade. Each of these three experimental trial visits will require ~5 hrs.
A single trial will ask that after being saturated in warm water, participants enter a 41°F air environment, immediately begin weighted treadmill walking (38.5lbs) at 2.0mph and up to 4% grade for a duration of 60 min before standing with minimal movement for 60 min. This trial will require ~4 hrs.
During all experimental trials, the primary outcomes include core temperature, measured continuously using a small pill inserted as a rectal suppository, and skin temperature, measured continuously using 11 small skin attached sensors. Secondary outcomes include metabolic rate, heart rate, thermal perceptions, and changes in body mass.
Non-federally employed civilians may be eligible to be paid $13.50/hour for participation (for a total of up to $310).
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Afton D Seeley, Ph.D.
- 전화번호: 508-206-2423
- 이메일: afton.d.seeley.civ@health.mil
연구 장소
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Massachusetts
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Natick, Massachusetts, 미국, 01760
- 모병
- USARIEM
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연락하다:
- Afton D Seeley, Ph.D.
- 전화번호: 508-206-2423
- 이메일: afton.d.seeley.civ@health.mil
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Military or civilian, male or female, between the ages of 18 (17 if active duty military) and 49 years.
- Able to carry a rucksack weighing 35 kg (77lbs) for at least 20 minutes and able to carry a rucksack weighing 17.5kg (38.5lbs) for up to 120 minutes
- In good health as determined by our OMSO (Office of Medical Support and Oversight) General Medical Clearance.
- Vaccinated against COVID 19.
- Willing to refrain from heavy exercise and alcoholic beverages for 24 hours before each testing session.
- Willing to refrain from smoking or tobacco use for 8 hours before each testing session.
- Willing to refrain from caffeine ingestion for 12 hours before each testing session.
- Body fat percentage <18% for males, < 24% for females, once 6 individuals of higher body fat (18% or greater for males, 24% or greater for females) have completed the study.
Exclusion Criteria:
- History of cold injuries.
- Raynaud's syndrome.
- Cold-induced asthma/bronchospasm.
- Medications or dietary supplements that could alter cardiovascular, thermoregulatory, or vascular control.
- Heart, lung, kidney, muscle, or nerve disorder(s).
- Planned MRI during or within two days after completing the study.
- Known allergy to adhesives.
- Female and pregnant, planning to become pregnant, or breastfeeding.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Improved Hot Weather Combat Uniform
Wearing the Improved Hot Weather Combat Uniform; Asked to perform 60 min of standing with minimal movement, 60 min weighted (38.5lb) treadmill walking at 2.0mph, up to 4% grade, 60 min weight (38.5lb) treadmill walking at 2.5mph, up to 4% grade.
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Water-saturated Improved Hot Weather Combat Uniform
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|
실험적: Army Combat Uniform
Wearing the Army Combat Uniform; Asked to perform 60 min of standing with minimal movement, 60 min weighted (38.5lb) treadmill walking at 2.0mph, up to 4% grade, 60 min weight (38.5lb) treadmill walking at 2.5mph, up to 4% grade.
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Water-saturated Army Combat Uniform
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실험적: Army Combat Uniform + Silk Weights
Wearing the Army Combat Uniform + a base layer of silk weights; Asked to perform 60 min of standing with minimal movement, 60 min weighted (38.5lb) treadmill walking at 2.0mph, up to 4% grade, 60 min weight (38.5lb) treadmill walking at 2.5mph, up to 4% grade.
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Water-saturated Army Combat Uniform + Silk Weights
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실험적: Army Combat Uniform- XR
Wearing the Army Combat Uniform; Asked to perform 60 min weighted (38.5lb) treadmill walking at 2.0mph, up to 4% grade, followed by 60 min of standing with minimal movement
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Water-saturated Army Combat Uniform
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Core Temperature
기간: 5 hours
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Core temperature will be measured using a temperature pill that is inserted as a rectal suppository.
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5 hours
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Skin Temperature
기간: 5 시간
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Skin temperature will be measured using 11 different skin-attached temperature sensors.
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5 시간
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Heart Rate
기간: 5 hours
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Heart Rate will be measured using telemetry [beats per min]
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5 hours
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산소 소비/대사열 생산(MHP)
기간: 최대 1시간까지 여러 5분 수집
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산소 소모량 및 MHP는 전산화된 간접 열량계[ml/kg/min; 제곱미터당 와트]
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최대 1시간까지 여러 5분 수집
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Thermal Sensation (whole body, feet, and hands)
기간: multiple 1 minute collections up to 1 hour
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Thermal sensation will be assessed using the American Society of Heating, Refrigerating and Air-conditioning Engineers Thermal Sensation Scale.
This scale has numbers from -4 to +4 with every whole number accompanied by a verbal expression.
The verbal expressions are used only to give the subject a relative feeling pertaining to the relative sensation.
For example, -4 is associated with very cold whereas +4 is associated with very hot.
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multiple 1 minute collections up to 1 hour
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Thermal Comfort
기간: multiple 1 minute collections up to 1 hour
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Thermal comfort will be assessed using a standard Thermal Comfort Scale.
We will ask volunteers to rate how comfortable they feel with respect to temperature sensation.
The scale has numbers ranging from 0 to 4 and with descriptors ranging from comfortable (0) to intolerable (4).
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multiple 1 minute collections up to 1 hour
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Perceived Skin Wetness
기간: multiple 1 minute collections up to 1 hour
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Perceived Skin Wetness will be assessed using an adapted Skin Wetness Perception Scale.
The scale ranges from 0 (extremely dry) to -6 (extremely wet; soaked).
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multiple 1 minute collections up to 1 hour
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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