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Icing and Airflow Stimulation in Obstructive Lung Diseases

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Group A-Diaphragmatic breathing
Group B-Icing and Airflow Stimulation
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Breathing Exercises, Icing and Airflow Stimulation, Chronic Obstructive Lung Diseases.

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A-Diaphragmatic breathing exercise

Group B-Icing and Airflow Stimulation

Arm Description

Diaphragmatic breathing exercise

Icing and Airflow Stimulation

Outcomes

Primary Outcome Measures

Peak Expiratory Flow (PEF)
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
Forced Expiratory Volume in 1 second (FEV1)
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Forced vital Capacity (FVC)
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters

Secondary Outcome Measures

Respiratory Rate
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.
Oxygen Saturation (SpO2)
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.
BORG SCALE
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.
Medical Research Council (MRC) Breathlessness scale
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).
ST. GEORGE RESPIRATORY QUESTIONAIRE
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.

Full Information

First Posted
March 5, 2019
Last Updated
August 7, 2019
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT03887364
Brief Title
Icing and Airflow Stimulation in Obstructive Lung Diseases
Official Title
Effect of Ice and Airflow Stimulation Versus Controlled Breathing Exercises to Reduce Dyspnea in Patients With Obstructive Lung Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 2, 2018 (Actual)
Primary Completion Date
June 15, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A randomized controlled trial in which icing and airflow stimulation for reduction of dyspnea in patients of obstructive lung disease was done which is characterized as condition of infection described by constant improvement of perpetual constraint of flow of air that is partially reversible and incorporates chronic bronchitis, emphysema and small airway diseases . The tools used were RR, Spirometry, Saturation, Borg Scale, MRC scale, shuttle walk test and St George's Respiratory Questionnaire (St.GRQ) score. Pulse oximeter measured the saturation levels and respiratory rates were alse observed. Borg scale measured rate of perceived exertion ranges from 6(easy physical activity) and 20(worst activity) and MRC measure dyspnea levels. In St.GRQ score between 1 to 8 is symptoms related and 9 to 17 was activity related.Literature review indicate that icing and airflow stimulation reduce dyspnea in patients of obstructive lung diseases.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Breathing Exercises, Icing and Airflow Stimulation, Chronic Obstructive Lung Diseases.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A-Diaphragmatic breathing exercise
Arm Type
Active Comparator
Arm Description
Diaphragmatic breathing exercise
Arm Title
Group B-Icing and Airflow Stimulation
Arm Type
Experimental
Arm Description
Icing and Airflow Stimulation
Intervention Type
Other
Intervention Name(s)
Group A-Diaphragmatic breathing
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Group B-Icing and Airflow Stimulation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Peak Expiratory Flow (PEF)
Description
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
Time Frame
4 weeks
Title
Forced Expiratory Volume in 1 second (FEV1)
Description
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Time Frame
4 weeks
Title
Forced vital Capacity (FVC)
Description
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Respiratory Rate
Description
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.
Time Frame
4 week
Title
Oxygen Saturation (SpO2)
Description
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.
Time Frame
4 weeks
Title
BORG SCALE
Description
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.
Time Frame
4 weeks
Title
Medical Research Council (MRC) Breathlessness scale
Description
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).
Time Frame
4 weeks
Title
ST. GEORGE RESPIRATORY QUESTIONAIRE
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iqbal Tariq, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22878278
Citation
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.
Results Reference
background
PubMed Identifier
12660371
Citation
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.
Results Reference
background
PubMed Identifier
16611654
Citation
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.
Results Reference
background
PubMed Identifier
24507833
Citation
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.
Results Reference
background
PubMed Identifier
22721264
Citation
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.
Results Reference
background
PubMed Identifier
26755942
Citation
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.
Results Reference
background
PubMed Identifier
23229114
Citation
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.
Results Reference
background
PubMed Identifier
12753535
Citation
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.
Results Reference
background
PubMed Identifier
20922100
Citation
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.
Results Reference
background
PubMed Identifier
9925061
Citation
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.
Results Reference
background
Citation
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).
Results Reference
background
PubMed Identifier
12775208
Citation
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.
Results Reference
background
PubMed Identifier
23233798
Citation
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.
Results Reference
background
PubMed Identifier
20601209
Citation
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.
Results Reference
background

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Icing and Airflow Stimulation in Obstructive Lung Diseases

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