- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03887364
Icing and Airflow Stimulation in Obstructive Lung Diseases
Effect of Ice and Airflow Stimulation Versus Controlled Breathing Exercises to Reduce Dyspnea in Patients With Obstructive Lung Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Constant obstructive Pulmonary disease (COPD) is an essential reason of mortality and bleakness everywhere throughout the world. In United States, COPD stands third in the causes of mortality with annual 100,000 deaths .An estimated 15 million people had COPD diagnosed with health care provider in 2010 and un-diagnosed cases are 12 million in number. In China ,COPD stands first among disability causes and becoming a reason of public health attention.According to an interpretation COPD overall rate of prevalence is 8.2% in China mortality rate of COPD is 1.6%.
In 12 countries/Cities of Asia-Pacific localies Model Projections of the commonness of Moderate-to-Severe instances of COPD in Those Persons > 30 years af age was total of 56,553,000 with total prevalance of 6.30%.Data are from the study held by the COPD regional working group.
Pakistan is a lower-middle-income country with a population of 182.1 million Pakistan, has a high load of chronic respiratory diseases a lower-middle-income country, with a population of 182.1 million. Age standardized death rate due to respiratory diseases is 138.2 per 100,000 in men and 41.3 per 100,000 in women in Pakistan.
"Effects of smoking mediation and the utilization of a breathed in anticholinergic bronchodilator on the rate of decrease of FEV1" presuming that This single intercession with the most extreme ability to impact the common history of COPD.in a lung wellbeing study assessment of the smoking suspension part demonstrates that if appropriate assets and time are given to end of smoking 25% quit rates can be picked up for long term.
an investigation in 2002 with the title of "Treating tobacco utilize and reliance" deriving that the act of conveying end of smoking help ought to take after "five A's" standards. The "five A's" of smoking discontinuance are Ask about utilization of tobacco, Advise to stop, Assess ability to influence an endeavor, To aid stop endeavor, Arrange development.
an exploration on " COPD-related dreariness and mortality in the wake of smoking discontinuance " inferring that concentrate of all the accessible writing underpins the elucidation that smoking suspension moderates the expanded rate of lung work decay and enhances survival as contrasted and kept smoking even in serious COPD.
" Arm situating adjusts lung volumes in subjects with COPD and solid subjects" which was distributed in Australian Journal of Physiotherapy reasoning that lung volumes were changed in subjects of COPD and sound subjects when looking at the arms situated over 90 degrees bear flexion with arms at or beneath 90 degrees bear flexion.In the COPD breathing at a higher volume of lung and having a diminished ability to take in a profound inhale when arms were over the head level may impact the capacity to do regular arm assignments that need height of the arms over the head. Change of the arm undertakings so arms are just lifted to 90 degrees may help in influencing arm to work more achievable for subjects with COPD.
In International Journal of Chronic Obstructive Pulmonary Disease reasoning that inspiratory muscle quality and intense exercise cause change of activity and respiratory muscle continuance execution and reductions dynamic hyperinflation and shortness of inhale amid exercise.
"Impact of cryotherapy and Airflow Stimulation Versus Controlled Breathing Exercise to Reduce Dyspnea in Patients With Obstructive Lung illness" In that they reasoned that facial icing and flow of air stimulation are viable and feasible technique for mitigating dyspnea in COPD patients.
Facial icing and airflow stimulation both of them were effective dyspnea relieving therapies which could be easily learnt by the COPD patient to overcome shortness of breathe on daily grounds. The point of this investigation was to decide the impact of Ice and Airflow Stimulation Versus Controlled Breathing Exercise to decrease Dyspnea in COPD patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Federal
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Islamabad, Federal, Pakistan, 44000
- Riphah International University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient having mild to moderate stage of COPD
Exclusion Criteria:
- Any facial injury and surgery.
- Sinusitis.
- Patient with respiratory failure.
- Patient having dyspnea on cardiac origin
- Patient having allergic rhinitis and Bronchitis.
- Patients having cystic fibrosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Group A-Diaphragmatic breathing exercise
Diaphragmatic breathing exercise
|
Patient was in casual and agreeable position in which gravity helped the stomach, for example, a semi fowler's position.
Hand was put on the rectus abdominis just beneath the foremost costal edge and requested that the patient take in gradually and profoundly through the nose.
Persistent was told to keep the shoulder casual and upper chest very, enabling the belly to rise marginally.
At that point persistent was guided to remain loose and breathed out gradually through the mouth.
The patient rehearsed this 3 to 4 times and the rest time frame was given so patient couldn't hyperventilate.This group was given 10 reps of 3 sets with 4 weeks of follow up
|
|
EXPERIMENTAL: Group B-Icing and Airflow Stimulation
Icing and Airflow Stimulation
|
Patient was lying comfortable in semi fowler position. Facial muscle icing was given using ice pack wrapped in cloth over cheeks and nose in butterfly pattern and over forehead for 5 minutes. Ice pack was applied on the patients face (around the cheek & nose) and accessory muscles (sternocleidomastoid muscles, upper trapezius) for single session of 5 to 10 minutes. After that airflow stimulation was given with the help of table fan. Table fan was placed on the central area of face. Duration of the fan for the patient was at least 5 minutes to relive dyspnea and distance kept approximate of 60 centimeter (2 rulers). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced Expiratory Volume in 1 second (FEV1)
Time Frame: 4 weeks
|
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
|
4 weeks
|
|
Peak Expiratory Flow (PEF)
Time Frame: 4 weeks
|
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
|
4 weeks
|
|
Forced vital Capacity (FVC)
Time Frame: 4 weeks
|
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory Rate
Time Frame: 4 week
|
Changes from Baseline.
The respiratory rate is the rate at which breathing happens.
This is normally estimated in breaths per minute and 12-20bpm normally, chest movements used for its measurement.
|
4 week
|
|
Oxygen Saturation (SpO2)
Time Frame: 4 weeks
|
Changes from baseline SPO2 was measured in percentage.
Oxygen immersion is the division of oxygen-soaked hemoglobin with respect to add up to hemoglobin in the blood.
Pulse oximeter measure it.
|
4 weeks
|
|
BORG SCALE
Time Frame: 4 weeks
|
Changes from Baseline Borg scale measure rate of perceived exertion which ranges from 6 to 20. 6 means easy physical activity and 20 means severe.
|
4 weeks
|
|
Medical Research Council (MRC) Breathlessness scale
Time Frame: 4 weeks
|
Changes from Baseline, MRC Dyspnea scale: it comprises of five explanations that portray nearly the whole scope of respiratory inability from none (Grade 1) to relatively total inadequacy (Grade 5).
|
4 weeks
|
|
ST. GEORGE RESPIRATORY QUESTIONAIRE
Time Frame: 4 weeks
|
changes from baseline questionnaire was measured A 50-item questionaire designed to measure impact on health status(quality of life) in patients with obstructive airway disease including COPD.Total 34 variables are included which are furthur sbudivided into two components: symptoms and activity/impact each consisting of 17 components.
A total Score is Calculated from 0 (no health Impairment) to 100 (Maximum health impairment).
In addition to the total score, there is also a score for each domain: symptoms, activity, and Impact which are scored 0-100 as well.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9.
- Regional COPD Working Group. COPD prevalence in 12 Asia-Pacific countries and regions: projections based on the COPD prevalence estimation model. Respirology. 2003 Jun;8(2):192-8. doi: 10.1046/j.1440-1843.2003.00460.x.
- Hnizdo E, Vallyathan V. Chronic obstructive pulmonary disease due to occupational exposure to silica dust: a review of epidemiological and pathological evidence. Occup Environ Med. 2003 Apr;60(4):237-43. doi: 10.1136/oem.60.4.237.
- Halbert RJ, Natoli JL, Gano A, Badamgarav E, Buist AS, Mannino DM. Global burden of COPD: systematic review and meta-analysis. Eur Respir J. 2006 Sep;28(3):523-32. doi: 10.1183/09031936.06.00124605. Epub 2006 Apr 12.
- Diaz-Guzman E, Mannino DM. Epidemiology and prevalence of chronic obstructive pulmonary disease. Clin Chest Med. 2014 Mar;35(1):7-16. doi: 10.1016/j.ccm.2013.10.002.
- Thornton Snider J, Romley JA, Wong KS, Zhang J, Eber M, Goldman DP. The Disability burden of COPD. COPD. 2012 Aug;9(5):513-21. doi: 10.3109/15412555.2012.696159. Epub 2012 Jun 21.
- Adeloye D, Chua S, Lee C, Basquill C, Papana A, Theodoratou E, Nair H, Gasevic D, Sridhar D, Campbell H, Chan KY, Sheikh A, Rudan I; Global Health Epidemiology Reference Group (GHERG). Global and regional estimates of COPD prevalence: Systematic review and meta-analysis. J Glob Health. 2015 Dec;5(2):020415. doi: 10.7189/jogh.05.020415.
- Prasad R, Singh A, Garg R, Giridhar GB. Biomass fuel exposure and respiratory diseases in India. Biosci Trends. 2012 Oct;6(5):219-28. doi: 10.5582/bst.2012.v6.5.219.
- Gupta V, Yadav K, Anand K. Patterns of tobacco use across rural, urban, and urban-slum populations in a north Indian community. Indian J Community Med. 2010 Apr;35(2):245-51. doi: 10.4103/0970-0218.66877.
- Mahon JL, Laupacis A, Hodder RV, McKim DA, Paterson NA, Wood TE, Donner A. Theophylline for irreversible chronic airflow limitation: a randomized study comparing n of 1 trials to standard practice. Chest. 1999 Jan;115(1):38-48. doi: 10.1378/chest.115.1.38.
- Yadav SG, Sule K, Palekar TJ. Effect of Ice and Airflow Stimulation Versus Controlled Breathing Exercise to Reduce Dyspnea in Patients With Obstructive Lung Disease. International Journal Of Scientific Research And Education. 2017;5(05).
- McKeough ZJ, Alison JA, Bye PT. Arm positioning alters lung volumes in subjects with COPD and healthy subjects. Aust J Physiother. 2003;49(2):133-7. doi: 10.1016/s0004-9514(14)60129-x.
- Petrovic M, Reiter M, Zipko H, Pohl W, Wanke T. Effects of inspiratory muscle training on dynamic hyperinflation in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2012;7:797-805. doi: 10.2147/COPD.S23784. Epub 2012 Nov 30.
- Ngai SP, Jones AY, Hui-Chan CW, Ko FW, Hui DS. Effect of 4 weeks of Acu-TENS on functional capacity and beta-endorphin level in subjects with chronic obstructive pulmonary disease: a randomized controlled trial. Respir Physiol Neurobiol. 2010 Aug 31;173(1):29-36. doi: 10.1016/j.resp.2010.06.005. Epub 2010 Jun 16.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RiphahIU Marium Javaid
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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