Formulation of an exercise program which will improve forbearance to low oxygen environment

Completed

Conditions: Trial for developing intervention that will prevent acute hypoxia induced maladies and improve functional exercise capacity.
Chronic respiratory patients with COPD and ILD.Trial for developing intervention that will prevent acute hypoxia induced maladies and improve functional exercise capacity

Registration Number: CTRI/2018/05/013984

Lead Sponsor: Dr Vishal Bansal

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 ***â€˜ischemic pre-conditioningâ€™*** 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Male

Target Recruitment: 80

Inclusion Criteria

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.
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.
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.
All participants with anemia shall be given appropriate therapy to raise hemoglobin levels to normal prior to induction in the study.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main outcome of this study is to develop a protocol in which â€˜ischemic pre-conditioningâ€™ 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 Measures

Name	Time	Method
Improvement in functional exercise capacity	10 weeks, after structured exercise training.

Trial Locations

Locations (2): Department of Physiology
🇮🇳
North, DELHI, India
Heat Physiology Group
🇮🇳
North, DELHI, India
Department of Physiology
🇮🇳North, DELHI, India
Dr Vishal Bansal
Principal investigator
drvishalbansal@hotmail.com