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IRCT20211223053495N1 IRCT 2022-06-10 Razi University Biomarkers and Acute Mountain Sickness after Active and Passive Ascents to High Altitude Biomarkers and Acute Mountain Sickness after Active and Passive Ascents to High Altitude in Healthy Men 2022-05-22 anticipated 15 Complete https://irct.ir/trial/61286 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Randomization description: Permuted block randomization: Allocation of subjects will be performed using permuted block randomization with two blocks of eight (one block for the mountaineering and one block for the cable car group). To do this, random allocation software will be used, and someone other than the researchers involved in performing the interventions and measurements will perform it. The random allocation software is a free software that can support block randomization (Version 1.0, May 2004; downloadable at https://mahmoodsaghaei.tripod.com/Softwares/randalloc.html). Each participant will be given a unique code (e.g. 01, 02, 03 …) and software will randomly generate two different groups as a printable document file. N/A Acute Mountain Sickness. Intervention 1: Intervention group1: On the day of the ascent, the mountaineers will start their ascent from an altitude of 1900 meters from the first station of the Tochal cable car at 8:00 AM. The subjects of mountaineering conditions travel the distance between stations one and two in about 1 hour, and from station two to station five about 2 hours, and from station five to the Tochal hotel about 3 hours, including 1 hour rest between the way and lunch. They arrive at the hotel at about 3:00 p.m. Subjects will return to the low altitude by cable car at 4:00 p.m on the second day of altitude. Intervention 2: Intervention group 2: On the day of ascent of the cable car subjects, at 8 o'clock in the morning from the first station of the Tochal cable car, they start their ascent from a height of 1900 meters with the cable car. Moving from station two: 10:15 am, Moving from the station Five: 2:30 p.m and arrival at the Tochal hotel is 3:00 p.m. The subjects of the cable car conditions will not have any sports or mountaineering activities and will only be sitting or walking slowly at the stations. Subjects will return to the low altitude by cable car at 4:00 p.m on the second day of altitude. After the implementation of the first program, in the second program, the two groups are replaced. An interval of at least two months between the two programs is considered to eliminate the effect of the compatibility of the first program. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Sahba Ariandoost
Tehran
Tehran Iran (Islamic Republic of) 1475753661 +98 83 3427 7605 sahbaemailbox@yahoo.com Razi University scientific Sahba Ariandoost
Tehran
Tehran Iran (Islamic Republic of) 1475753661 +98 83 3427 7605 sahbaemailbox@yahoo.com Razi University Iran (Islamic Republic of) Healthy men 20 to 29 years Lived for at least 6 months in Tehran Body mass index 18.5 to 24.9 (kg.m2) At least two weeks have passed since the second dose of Corona vaccine was given 20 years 29 years Male Having any acute or chronic illness Suffering from psychological or skeletal disorders smoking Climbing to altitudes of more than 2500 meters in the two months before the start of the research Blood donation in the two months before the start of the research Flight by aircraft in the two months prior to the start of the research History of high-altitude sports such as mountaineering, skiing and air sports T70.29 Other effects of high altitude Prevention Prevention Intervention group1: On the day of the ascent, the mountaineers will start their ascent from an altitude of 1900 meters from the first station of the Tochal cable car at 8:00 AM. The subjects of mountaineering conditions travel the distance between stations one and two in about 1 hour, and from station two to station five about 2 hours, and from station five to the Tochal hotel about 3 hours, including 1 hour rest between the way and lunch. They arrive at the hotel at about 3:00 p.m. Subjects will return to the low altitude by cable car at 4:00 p.m on the second day of altitude. Intervention group 2: On the day of ascent of the cable car subjects, at 8 o'clock in the morning from the first station of the Tochal cable car, they start their ascent from a height of 1900 meters with the cable car. Moving from station two: 10:15 am, Moving from the station Five: 2:30 p.m and arrival at the Tochal hotel is 3:00 p.m. The subjects of the cable car conditions will not have any sports or mountaineering activities and will only be sitting or walking slowly at the stations. Subjects will return to the low altitude by cable car at 4:00 p.m on the second day of altitude. After the implementation of the first program, in the second program, the two groups are replaced. An interval of at least two months between the two programs is considered to eliminate the effect of the compatibility of the first program. Acute Mountain Sickness. Timepoint: About 2 and 6 hours after arrival at the hotel at high altitude as well as the next morning. Method of measurement: Lake Louise Score. Changes in serum interleukin 6 levels. Timepoint: 4 p.m, day before the ascent, 4 p.m, day of the ascent (one hour after arriving at the hotel at high altitude), 4 p.m, the next day (before returning to low altitude). Method of measurement: Blood sampling. Changes in serum endothelin 1 levels. Timepoint: 4 p.m, day before the ascent, 4 p.m, day of the ascent (one hour after arriving at the hotel at high altitude), 4 p.m, the next day (before returning to low altitude). Method of measurement: Blood sampling. Changes in serum Tumor Necrosis Factor-α levels. Timepoint: 4 p.m, day before the ascent, 4 p.m, day of the ascent (one hour after arriving at the hotel at high altitude), 4 p.m, the next day (before returning to low altitude). Method of measurement: Blood sampling. Changes in serum Heat Shock Protein levels. Timepoint: 4 p.m, day before the ascent, 4 p.m, day of the ascent (one hour after arriving at the hotel at high altitude), 4 p.m, the next day (before returning to low altitude). Method of measurement: Blood sampling. Changes in serum Cortisol levels. Timepoint: 4 p.m, day before the ascent, 4 p.m, day of the ascent (one hour after arriving at the hotel at high altitude), 4 p.m, the next day (before returning to low altitude). Method of measurement: Blood sampling. Changes in arterial blood oxygen saturation levels. Timepoint: 4 p.m, the day before the ascent, at the first station of the cable car before the ascent, as well as at stations two and five, at the hotel at high altitude after a 10-minute rest, one hour after arriving at the hotel, at 4 p.m the next day (before returning to low height). Method of measurement: By pulse oximeter device. Resting heart rate changes. Timepoint: 4 p.m, the day before the ascent, at the first station of the cable car before the ascent, as well as at stations two and five, at the hotel at high altitude after a 10-minute rest, one hour after arriving at the hotel, at 4 p.m the next day (before returning to low height). Method of measurement: Pulse meter. Resting blood pressure changes. Timepoint: 4 p.m, day before the ascent, 4 p.m, day of the ascent (one hour after arriving at the hotel at high altitude), 4 p.m, the next day (before returning to low altitude). Method of measurement: sphygomanometer. Anxiety levels. Timepoint: The day before the ascent at 4:00 p.m, the day of the ascent about 2 and 6 hours after entering the hotel at high altitude and also the next morning before returning to low altitude. Method of measurement: Anxiety Disorders Questionnaire. Razi University Approved 2021-11-10 Ethics committee of Razi University Razi University, University Ave, Taq-e Bostan, Kermanshah Kermanshah Iran (Islamic Republic of)