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| Name | Class |
|---|---|
| Xuanwu Hospital, Beijing | OTHER |
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Several studies have shown cognitive impairment such as memory, perception and learning skill during ascent to high altitudes. However, few studies have directly investigated the effect of high altitudes exposure on attention-a high-level cognitive function. Remote ischemic conditioning (RIC) is a noninvasive and easy-to-use neuroprotective strategy, It has been proven to be an effective strategy for neuroprotection in ischemic stroke and chronic cerebral ischemia patients.
This study will provide insights into the preliminary proof of principle, safety, cognitive dysfunction and blood oxygen levels protective effects of RIC in Adults Exposing to High Altitude Conditions, and this data will provide parameters for future larger scale clinical trials if efficacious.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Altitude RIC group | Experimental | Thirty young healthy males from the altitude of 3700 meters will be allocated to the High Altitude RIC group. They will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 200 mmHg for five cycles of 5 min followed by 5 min of relaxation of the cuffs, performed twice a day for a total of 7 days. The treatment was carried out using an electric auto-control device (patent number ZL200820123637.X, China) |
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| High Altitude Sham group | Sham Comparator | Thirty young healthy males from the altitude of 3700 meters will be allocated to the High Altitude Sham group. They will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 60 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs, performed twice a day for a total of 7 days. |
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| Low Altitude RIC group | Experimental | Thirty young healthy males from the altitude of 42 meters will be allocated to the Low Altitude RIC group. They will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 200 mmHg for five cycles of 5 min followed by 5 min of relaxation of the cuffs, performed twice a day for a total of 7 days. The treatment was carried out using an electric auto-control device. |
|
| Low Altitude Sham group | Sham Comparator | Thirty young healthy males from the altitude of 42 meters will be allocated to the Low Altitude Sham group. They will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 60 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs, performed twice a day for a total of 7 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RIC | Device | Adults allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 200 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs. |
| Measure | Description | Time Frame |
|---|---|---|
| Attentional network test | The computer software attentional network test (ANT) as described by Fan et al. in 2002 will be used to measuring the Orienting function, executive function and alerting function. | change from baseline (pre-RIC treatment) at 7days after RIC treatment |
| Measure | Description | Time Frame |
|---|---|---|
| basic fibroblast growth factor | basic fibroblast growth factor will be detected. Blood samples will be drawn from cubital vein to test these biomarkers. | change from baseline (pre-RIC treatment) at 7 days after RIC treatment |
| platelet derived growth factor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lian Duan, MD PHD | Contact | 861013911365592 | duanlian307@sina.com | |
| Han Cong, MD MS | Contact | 861013466346163 | hc82225@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Lian Duan, MD PHD | The 307th Hospital of Military Chinese People's Liberation Army | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19161909 | Background | Wilson MH, Newman S, Imray CH. The cerebral effects of ascent to high altitudes. Lancet Neurol. 2009 Feb;8(2):175-91. doi: 10.1016/S1474-4422(09)70014-6. | |
| 23035060 | Background | Meng R, Asmaro K, Meng L, Liu Y, Ma C, Xi C, Li G, Ren C, Luo Y, Ling F, Jia J, Hua Y, Wang X, Ding Y, Lo EH, Ji X. Upper limb ischemic preconditioning prevents recurrent stroke in intracranial arterial stenosis. Neurology. 2012 Oct 30;79(18):1853-61. doi: 10.1212/WNL.0b013e318271f76a. Epub 2012 Oct 3. |
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| sham RIC | Device | Adults allocated to the sham group will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 60 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs. |
|
platelet derived growth facto will be detected. Blood samples will be drawn from cubital vein to test these biomarkers. |
| change from baseline (pre-RIC treatment) at 7 days after RIC treatment |
| vascular endothelial growth factor | vascular endothelial growth factor will be detected. Blood samples will be drawn from cubital vein to test these biomarkers. | change from baseline (pre-RIC treatment) at 7 days after RIC treatment |
| the rate of Adverse event | Any adverse event will be reported and its relationship with the RIC intervention will be evaluated. | change from baseline (pre-RIC treatment) at 7 days after RIC treatment |
| distal radial pulses | It is an aspect which can reflect the safety of remote ischemic conditioning | within 7 days after RIC treatment |
| the number of erythema in the skin | It is an aspect which can reflect the safety of remote ischemic conditioning | within 7 days after RIC treatment |
| the number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure | it is an aspect which can reflect the safety of remote ischemic conditioning | within 7 days after RIC treatment |
| the number of patients with any other adverse events related to RIC intervention as determined by the principle investigator. | it is an aspect which can reflect the safety of remote ischemic conditioning | within 7 days after RIC treatment |
| heart rate | the heart rate will be measured by automatic blood pressure monitor | change from baseline(pre-RIC treatment) at 7days after RIC treatment |
| blood pressure | Both systolic, and diastolic pressure will be measured by automatic blood pressure monitor | change from baseline(pre-RIC treatment) at 7days after RIC treatment |
| blood oxygen saturation (SaO2) | The portable oxygen saturation ward apparatus (Datex -Ohmeda, USA) will be used to monitor the blood oxygen saturation (SaO2) | change from baseline(pre-RIC treatment) at 7days after RIC treatment |
| cerebral oxygen saturation(TOI) | The cerebral oxygen monitor (EGOS-600, Jiangsu China) will be used to monitor the cerebral oxygen saturation (TOI). | change from baseline(pre-RIC treatment) at 7days after RIC treatment |
| The peak systolic blood flow velocity (PSV) of bilateral middle cerebral artery (MCA) | This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards | change from baseline(pre-RIC treatment) at 7days after RIC treatment |
| end-diastolic blood flow velocity (EDV) of bilateral middle cerebral artery (MCA) | This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards | change from baseline(pre-RIC treatment) at 7days after RIC treatment |
| the mean flow velocity (MFV) of the subjects' bilateral middle cerebral artery (MCA) | This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards | change from baseline (pre-RIC treatment) at 7 days after RIC treatment |
| pulse index (PI) of the subjects' bilateral middle cerebral artery (MCA) | This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards | change from baseline (pre-RIC treatment) at 7 days after RIC treatment |
| The degree of palpation of tenderness--visual analogue scale | The degree of palpation of tenderness is an aspect which can reflect the safety of remote ischemic conditioning. The pain was assessed with visual analogue scale ( VAS) | within 7 days after RIC treatment |
| the number of patients with any other adverse events related to RIC intervention as determined by the principle investigator | it is an aspect which can reflect the safety of remote ischemic conditioning | within 7 days after RIC treatment |
| 25956401 | Background | Meng R, Ding Y, Asmaro K, Brogan D, Meng L, Sui M, Shi J, Duan Y, Sun Z, Yu Y, Jia J, Ji X. Ischemic Conditioning Is Safe and Effective for Octo- and Nonagenarians in Stroke Prevention and Treatment. Neurotherapeutics. 2015 Jul;12(3):667-77. doi: 10.1007/s13311-015-0358-6. |
| 11970796 | Background | Fan J, McCandliss BD, Sommer T, Raz A, Posner MI. Testing the efficiency and independence of attentional networks. J Cogn Neurosci. 2002 Apr 1;14(3):340-7. doi: 10.1162/089892902317361886. |
| 2183676 | Background | Posner MI, Petersen SE. The attention system of the human brain. Annu Rev Neurosci. 1990;13:25-42. doi: 10.1146/annurev.ne.13.030190.000325. No abstract available. |
| 17697477 | Background | Godfrey E, Chalder T, Ridsdale L, Seed P, Ogden J. Investigating the active ingredients of cognitive behaviour therapy and counselling for patients with chronic fatigue in primary care: developing a new process measure to assess treatment fidelity and predict outcome. Br J Clin Psychol. 2007 Sep;46(Pt 3):253-72. doi: 10.1348/014466506X147420. |
| 29042490 | Background | Wang Y, Meng R, Song H, Liu G, Hua Y, Cui D, Zheng L, Feng W, Liebeskind DS, Fisher M, Ji X. Remote Ischemic Conditioning May Improve Outcomes of Patients With Cerebral Small-Vessel Disease. Stroke. 2017 Nov;48(11):3064-3072. doi: 10.1161/STROKEAHA.117.017691. Epub 2017 Oct 17. |
| 28708702 | Background | Twomey R, Wrightson J, Fletcher H, Avraam S, Ross E, Dekerle J. Exercise-induced Fatigue in Severe Hypoxia after an Intermittent Hypoxic Protocol. Med Sci Sports Exerc. 2017 Dec;49(12):2422-2432. doi: 10.1249/MSS.0000000000001371. |