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CTRI Number  CTRI/2018/05/013984 [Registered on: 21/05/2018] Trial Registered Retrospectively
Last Modified On: 24/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Intervention includes Exercise training and Ischemic Preconditioning]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Formulation of an exercise program which will improve forbearance to low oxygen environment  
Scientific Title of Study   Development of Exercise Protocol to Improve Hypoxic Tolerance  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vishal Bansal 
Designation  Assistant Professor 
Affiliation  Vallabhbhai Patel Chest Institute 
Address  Department of Physiology, Vallabhbhai Patel Chest Institute, Delhi University
Department of Physiology
North
DELHI
110007
India 
Phone  91-11-27402406  
Fax  91-11-27666549  
Email  drvishalbansal@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vishal Bansal 
Designation  Assistant Professor 
Affiliation  Vallabhbhai Patel Chest Institute 
Address  Department of Physiology, Vallabhbhai Patel Chest Institute, Delhi University
Department of Physiology
North
DELHI
110007
India 
Phone  91-11-27402406  
Fax  91-11-27666549  
Email  drvishalbansal@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vishal Bansal 
Designation  Assistant Professor 
Affiliation  Vallabhbhai Patel Chest Institute 
Address  Department of Physiology, Vallabhbhai Patel Chest Institute, Delhi University
Department of Physiology
North
DELHI
110007
India 
Phone  91-11-27402406  
Fax  91-11-27666549  
Email  drvishalbansal@hotmail.com  
 
Source of Monetary or Material Support  
Defence Research and Development Organization, Defence Institute of Physiology and Allied Sciences, Lucknow Road, Timarpur, Delhi-110054 
 
Primary Sponsor  
Name  Dr Vishal Bansal 
Address  Department of Physiology, Vallabhbhai Patel Chest Institute, Delhi University, Delhi-110007  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vishal Bansal  Department of Physiology  Vallabhbhai Patel Chest Institute, Delhi University, Delhi-110007
North
DELHI 
27402406
27666549
drvishalbansal@hotmail.com 
Dr Rajinder Kumar Gupta  Heat Physiology Group   Defence Institute of Physiology and Allied Sciences (DIPAS), Lucknow Road, Timarpur, Delhi-110054
North
DELHI 
23883072
23914790
rajindergupta21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, DIPAS  Approved 
Institutional Ethics Committee, VPCI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Trial for developing intervention that will prevent acute hypoxia induced maladies and improve functional exercise capacity. 
Patients  Chronic respiratory patients with COPD and ILD. Trial for developing intervention that will prevent acute hypoxia induced maladies and improve functional exercise capacity ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Exercise training, Ischemic pre-conditioning  Participants will continue their routine activity and medications and will also be provided structured exercise training with or without ischemic pre-conditioning. 
Comparator Agent  No exercise training or ischemic pre-conditioning  Participants will continue their routine activity and medication. No exercise training or ischemic pre-conditioning will be provided. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  65.00 Year(s)
Gender  Male 
Details  1. All participants must have quit smoking at least eight weeks before inclusion into the study or are non-smokers.
2.Participants with a clinical diagnosis of moderate to severe chronic respiratory disease requiring enrollment into pulmonary rehabilitation program for their disease management.
3. Participants who have completed supervised pulmonary rehabilitation program at least three months earlier and require re-induction into the program for their management.
4.Participants on long term oxygen therapy, their detailed record of requirement and usage of such therapy shall be maintained.
5. All patient participants should be compliant to pharmacotherapy for their disease management at least one month prior to induction into the study to eliminate the confounding effect due to improvement imparted by pharmacotherapy.
6. All participants with anemia shall be given appropriate therapy to raise hemoglobin levels to normal prior to induction in the study.

 
 
ExclusionCriteria 
Details  1.Patient participants having co-morbidities likely to affect the study parameters like Pulmonary artery hypertension, Obesity hypoventilation, cor pulmonale.
2.Exercise intolerance due to heart failure, angina pectoris, dyspnea of cardiac origin
3.Endocrinal disorders such as Diabetes mellitus, thyroid disorder which is likely to cause autonomic dysfunction.
4.Participants in both the groups having episode of acute infection in the month preceding induction into the study or during the study period and patients requiring course of oral steroids during the course of study shall be excluded from the study.
5.Physiological, musculoskeletal, neurological or psychological impairment impeding training program.
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Main outcome of this study is to develop a protocol in which ‘ischemic pre-conditioning’ will be added to the routine activity or a structured exercise program that will lead to increase in tolerance to hypoxia.  10 Weeks, improvement in tolerance to acute hypoxia exposure.
14 weeks, sustenance of improvement achieved in tolerance to acute hypoxia exposure  
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in functional exercise capacity  10 weeks, after structured exercise training.
14 weeks, sustenance of improvement in functional exercise capacity  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "51"
Final Enrollment numbers achieved (India)="51" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/11/2015 
Date of Study Completion (India) 08/09/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   1. Foster GP, Paresh CG, Douglas MR, Sophia RL and James DA. Ischemic preconditioning improves oxygen saturation and attenuates hypoxic pulmonary vasoconstriction at high altitude. High Alt Med Biol 2014; 15:155–61. 2.Foster GP, Westerdahl DE, Foster LA, Hsu JV, and Anholm JD. Ischemic preconditioning of the lower extremity attenuates the normal hypoxic increase in pulmonary artery systolic pressure. Respir Physiol Neurobiol 2011; 179: 248–53.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

INTRODUCTION

Advanced transport technology gives people opportunity to visit high altitude within short time. Therefore, not enough time is available for them to acclimatize to the hypoxic environment and this is typically associated with decreased arterial oxygen saturation and increased pulmonary artery pressures, both of which contribute to the impaired exercise performance experienced there. Significant portion of this impairment is attributed to hypoxic pulmonary vasoconstriction (HPV). This response leads to increased pulmonary arterial pressure resulting in increased right ventricular afterload and decreased cardiac output. The complex underlying mechanisms responsible for HPV are suggested to be largely mediated through vasoactive and inflammatory pathways. Though pharmacological and non-pharmacological interventions to attenuate HPV at simulated and high altitude environments improve arterial oxygen saturation (SpO2), still, inconstant results have been observed in exercise performance. These outcomes in healthy subjects have important implications in clinical practice, for example, common high morbidity conditions such as sleep apnea syndromes, chronic obstructive pulmonary disease, interstitial lung diseases, congestive heart failure and critically ill patients requiring respiratory support are often complicated by HPV.

 Exercise training is being increasingly used in the management of patients with acute and chronic cardio-respiratory diseases where it has been clearly demonstrated to reduce dyspnea, increase exercise performance and improve health-related quality of life (HRQL). Meta-analyses and systemic reviews have shown that beneficial effects of exercise training are mediated by reduction in inflammatory and oxidative stress markers, improvement of endothelial function, increased oxidative capacity & skeletal muscle mass, enhanced vagal and lower sympathetic tone in chronic heart and respiratory patients.

 Recently, ischemic preconditioning (IPC), a procedure which is performed by repetitive occlusion of arterial blood flow to an organ or extremity (e.g., 5 minutes occlusion, followed by 5 minutes of restored blood flow, repeated several times) has been shown to induce systemic effects that protect the myocardium and other organs from subsequent ischemic injury. In acute coronary syndrome, ischemic conditioning has been shown to reduce infarct size and incidence of arrhythmias while recovery of contractile and vascular function is taking place. These effects have also been observed in pulmonary vasculature, where it has been demonstrated that the hypoxic increase in pulmonary artery systolic pressure during acute simulated altitude conditions is significantly attenuated by IPC. The protective effects of IPC on local and remote tissues are largely attributed to effects on vasoactive and inflammatory pathways.

Since IPC and HPV have similar mechanistic pathways i.e. hypoxia, but confer opposing effects, it is hypothesized that IPC exposure would attenuate HPV and improve hypoxic tolerance. Further, in view of the fact that exercise training is known to improve exercise capacity in chronic respiratory disease patients, this study will also examine whether addition of IPC before exercise training imparts greater increase in exercise endurance.

LACUNAE IN LITERATURE

           There are studies that show relationship between ischemic pre-conditioning (IPC) and attenuation in hypoxic pulmonary vasoconstriction (HPV) in exercising, healthy subjects.  However, the impact of IPC on hypoxia response and exercise training in chronic respiratory patients is yet to be evaluated.  

 AIMS

        Aim of this study is to develop a protocol in which ‘ischemic pre-conditioning’ will be added to the routine activity or an exercise program that will lead to increase in tolerance to hypoxia. 

HYPOTHESIS

       It is hypothesized that ischemic pre-conditioning along with structured exercise training will provide tolerance to acute hypoxia exposure and prevent hypoxic pulmonary vasoconstriction. Secondarily, it will also improve functional exercise capacity.

 
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