ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT05869747 (FCRP) के लिए संपर्क, हृदय फुफ्फुसीय वर्तमान में सक्रिय, भर्ती नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
Firefighter Collaborative Research Project (FCRP)
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'परीक्षण समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल परीक्षण NCT05869747 (FCRP) एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो संपर्क, हृदय फुफ्फुसीय से जुड़ा हुआ है। परीक्षण वर्तमान में सक्रिय, भर्ती नहीं चल रहा है। इसकी शुरुआत 22 जून 2023 को हुई थी, और इसमें कुल 1,500 प्रतिभागियों के नामांकन की योजना है। University of Arizona इस परीक्षण का नेतृत्व कर रहे हैं और इसके 31 दिसंबर 2025 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 4 जून 2025 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
The goal of this research is to test interventions to reduce firefighter cardiovascular, cognitive, and overall disease risks, including but not limited to risks associated with Per- and Polyfluorinated Substances (PFAS) exposure. Approximately 1,500 - 2,000 firefighters will be enrolled in the Fire Fighter Cancer Cohort Study (FFCCS). Among these individuals, those that express interest will then be screened for eligibility for the Firefighter Collaborative Research Project (FCRP) using information they provided for the Fire Fighter Cancer Cohort Study. Firefighters enrolled in the study will provide an initial blood sample and urine sample. The blood sample will be analyzed to determine the participant's PFAS levels. Based upon serum PFAS levels and responses from the screening survey, eligible participants will be randomly assigned into one of the following interventions: 1. Blood Donation, or Plasma Donation or Blood/Plasma Control Group; 2. Zone 2 Training or Zone 2 Control; 3. Intermittent Fasting or Intermittent Fasting Control. Individuals participating in the blood donation, plasma donation or blood/plasma control group would donate blood every 12 weeks, plasma every 6 weeks, or not donate blood or plasma. Participants in this intervention arm would continue this for a 12-month period. Individuals in the zone 2 training, zone 2 training control, intermittent fasting or intermittent fasting control group would participate in their intervention or control for a 4-month period. After 4 to 12 months participating in an intervention or control group, participants will be asked to provide a final urine sample and blood draw to determine if and to what degree their PFAS levels or other cardiovascular disease and other health risks have changed.
आधिकारिक शीर्षक
Firefighter Collaborative Research Project
चिकित्सीय स्थितियाँ
संपर्कहृदय फुफ्फुसीयप्रकाशन
इस नैदानिक परीक्षण के बारे में प्रकाशित वैज्ञानिक लेख और शोध पत्र:अन्य अध्ययन आईडी
- FCRP
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2023-06-22
अंतिम अद्यतन प्रकाशित
2025-06-04
अध्ययन की समाप्ति तिथि (अनुमानित)
2025-12-31
नामांकन (अनुमानित)
1,500
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
सक्रिय, भर्ती नहीं
प्रमुख शब्द
Firefighters
प्राथमिक उद्देश्य
अन्य
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
एकल अंध
समूह/हस्तक्षेप
| प्रतिभागी समूह/हाथ | हस्तक्षेप/इलाज |
|---|---|
सक्रिय तुलना समूहBlood Donation | रक्तदान Participants asked to donate whole blood at a donation facility from a list provided by the study. सर्वेक्षण Participants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data. |
सक्रिय तुलना समूहPlasma Donation | Plasma Donation Participants asked to donate plasma at a donation facility from a list provided by the study. सर्वेक्षण Participants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data. |
प्लेसबो तुलना समूहBlood/Plasma Control | सर्वेक्षण Participants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data. |
सक्रिय तुलना समूहZone 2 Training | Zone 2 Training Participants asked to work out in their custom Zone 2 heart range 4 times a week for 45 to 60 minutes. सर्वेक्षण Participants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data. |
सक्रिय तुलना समूहIntermittent Fasting | आंतरायिक उपवास Participants asked to engage in an intermittent fasting routine of a 16 hour fast followed by an 8 hour eating period at least 4 times a week. सर्वेक्षण Participants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data. |
प्लेसबो तुलना समूहZone 2 Control | सर्वेक्षण Participants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data. |
प्लेसबो तुलना समूहIntermittent Fasting Control | सर्वेक्षण Participants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data. |
प्राथमिक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Change in concentration of PFAS levels in serum | PFAS levels are per- and polyfluoroalkyl substance levels measured from a biological sample | 12 months |
Change in epigenetic age | Epigenetic age is a mathematically derived age estimators that are based on combinations of methylation values that change with age at specific CpGs in the genome. | 4 months |
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
स्वस्थ स्वयंसेवकों को स्वीकार करता है
हाँ
- Active firefighter (including emergency medical responder and all firefighter subgroups) with either a volunteer or career status
- Individual plans to remain in active service with their current agency for the next 2 years (not planning to retire or resign)
- 18 years of age and older
- Fluently speak and write in English
- All sexes, races, and ethnicities
- Enrolled in the Fire Fighter Cancer Cohort Study (FFCCS) prior to enrolling in the Firefighter Collaborative Research Project (FCRP)
- Complete a signed and dated informed consent document that indicates the participant has been informed of all aspects of the study prior to enrollment
- Agree to avoid participating in FCRP intervention activities outside of their assigned intervention group for the duration of the study
- Able to comply with scheduled visits, laboratory tests and other study procedures
- BMI of 17.5 kg/m2 or greater and be greater than 115 pounds
- Must also be eligible to donate blood and blood-based products if randomized into the blood or plasmapheresis intervention groups
- Not able to fluently speak or write in English
- Less than 18 years of age
- Currently a tobacco smoker or vaping (e.g. >2 cigarettes or cigars, or incidents of vaping in the past month)
- Those with planned travel or extended leave (e.g. >6 weeks) that would prevent their ability to participate in other interventions
- Those who are pregnant, breastfeeding, or have given birth within the past year
- Those with a history or diagnosis of any significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, immune, hepatic, renal, urological disorders, severe injury or cancer that, in the opinion of the investigator, would potentially put the candidate at risk.
Exclusion criteria from study for those outside of Arizona:
• Those with PFOS levels <5 ng/ml
Exclusion criteria from blood or plasma donation intervention:
- Those with any medical contraindication (medical condition or medication) to blood donation
- Those that donated blood or plasma in the past three months
- Those knowing they have a condition indicative of levels of hemoglobin, hematocrit, red blood cells, or iron below the lower limit of normal levels
Exclusion criteria from the intermittent fasting intervention:
- Those with a history or diagnosis of diabetes, hypoglycemia thyroid disease, and/or an eating disorder
- Those who recently participated in intermittent fasting or Time Restricted Eating
- Those that recently used antidiabetic medication such as Semaglutide (sold as Ozempic, Wegovy, and Rybelsus) or Tirzepatide (sold as Mounjaro) for the treatment of type 2 diabetes or for weight loss will also be excluded from this group.
- Use of drugs that might affect intermittent fasting or eating behaviors
- Those outside of the state of Arizona
Exclusion from the zone-2 physical activity intervention:
- Currently participating in zone 2 physical activity training
- Currently participating in more than 120 minutes per week of aerobic, cardiovascular training (e.g. jogging, cycling, walking, swimming, HIIT) at >60% of their max heart rate.
- Those outside of the state of Arizona or in cities in Arizona where access to CPET testing is not possible
University of Arizonaएरिजोना स्टेट विश्वविद्यालयकोई संपर्क डेटा नहीं।
7 1 देशों में अध्ययन स्थल
Arizona
Gilbert Fire & Rescue Department, Gilbert, Arizona, 85295, United States
Green Valley Fire, Green Valley, Arizona, 85622, United States
Tucson Fire Department Headquarters, Tucson, Arizona, 85701, United States
Tucson Fire Department Station 9, Tucson, Arizona, 85711, United States
University of Arizona, Tucson, Arizona, 85719, United States
Northwest Fire District, Tucson, Arizona, 85743, United States
Drexel Heights Fire, Tucson, Arizona, 85746, United States