Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Icing and Airflow Stimulation in Obstructive Lung Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03887364
Recruitment Status : Completed
First Posted : March 22, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Riphah International University

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: Group A-Diaphragmatic breathing Other: Group B-Icing and Airflow Stimulation Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Ice and Airflow Stimulation Versus Controlled Breathing Exercises to Reduce Dyspnea in Patients With Obstructive Lung Disease
Actual Study Start Date : February 2, 2018
Actual Primary Completion Date : June 15, 2018
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A-Diaphragmatic breathing exercise
Diaphragmatic breathing exercise
Other: Group A-Diaphragmatic breathing
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
Other: Group B-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).





Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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. 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).

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887364


Locations
Layout table for location information
Pakistan
Riphah International University
Islamabad, Federal, Pakistan, 44000
Sponsors and Collaborators
Riphah International University
Investigators
Layout table for investigator information
Principal Investigator: Iqbal Tariq, MS Riphah International University

Publications:
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).

Layout table for additonal information
Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT03887364    
Other Study ID Numbers: RiphahIU Marium Javaid
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riphah International University:
Breathing Exercises
Icing and Airflow Stimulation
Chronic Obstructive Lung Diseases.
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases