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
|
|
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
|
|
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. |