Resistive Breathing Versus Inspiratory Hold Technique in Patients With Chronic Bronchitis

Comparison of Resistive Breathing Versus Inspiratory Hold Technique in Patients With Chronic Bronchitis

The aim of the study is to determine the importance and impact of resistive breathing techniques versus inspiratory hold techniques in patients with chronic bronchitis and specially to find out if there are any changes seen in results measured via the incentive spirometer.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Bronchitis
• Intervention / Treatment: Other: Resistive Breathing Training group; Other: inspiratory hold technique

Detailed Description

Chronic Bronchitis (CB) is defined as a chronic cough and sputum production for at least 3 months a year for 2 consecutive years. It is covered under the umbrella term of Chronic Obstructive Pulmonary Disease (COPD). Chronic bronchitis is thought to be caused by overproduction and hypersecretion of mucus by goblet cells. Epithelial cells lining the airway response to toxic, infectious stimuli by releasing inflammatory mediators and e.g. pro-inflammatory cytokines. During an acute exacerbation of chronic bronchitis, the bronchial mucous membrane becomes hyperemic and edematous with diminished bronchial mucociliary function. This, in turn, leads to airflow impediment because of

luminal obstruction to small airways. The airways become clogged by debris and this further increases the irritation. The characteristic cough of bronchitis is caused by the copious secretion of mucus in chronic bronchitis. Pseudostratified epithelium, highlighting the pseudostratified epithelial cells, goblets cells (shown in blue), then underlying connective tissue.(3) To determine the importance and impact of resistive breathing techniques versus inspiratory hold techniques in patients with chronic bronchitis and specially to find out if there are any changes seen in results measured via incentive spirometer. There are few studies done over it whereas purpose of this research work is to compare these techniques to get better results.

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ghazal Jamshaid, MS CPPT; Phone Number: 03040404851; Email: ghazaljamshaid141@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 53700
      • Mayo Hospital
      • Principal Investigator: Wajeeha Zia, MSPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • Diagnosed with chronic bronchitis

  • Clinically stable patients.
  • Both genders.
  • Age 45 to 60 years.
  • Pink puffers included in this study
  • Clients that are involved in research are not allowed for other interventional therapies. They can take their regular medications.
  • Patients diagnosed at least 2 years ago with bronchitis.

Exclusion Criteria:

• • Presence of any genetic disorders (cystic fibrosis).

  • Recent spinal / chest surgery
  • Cardiac issues
  • Fractures of vertebra caused by osteoporosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resistive Breathing Training group; The patients performed two sessions each of 15 minutes session of resistive breathing for four days a week for six weeks using an inspiratory resistive device. Ask patient to take long slow inspirations while breathing through the resistive device	Other: Resistive Breathing Training group; The patients performed two sessions each of 15 minutes session of resistive breathing for four days a week for six weeks using an inspiratory resistive device. Ask patient to take long slow inspirations while breathing through the resistive device
Active Comparator: inspiratory hold technique; With the patient in a comfortable position such as side lying or reclined, the therapist may assist the patient by placing both hands on abdominal area to provide proprioceptive feedback. Then in a relaxed tone of voice therapist instructs the patient to sniff quickly through the nose three times with slow, relaxed exhalations	Other: inspiratory hold technique; With the patient in a comfortable position such as side lying or reclined, the therapist may assist the patient by placing both hands on abdominal area to provide proprioceptive feedback. Then in a relaxed tone of voice therapist instructs the patient to sniff quickly through the nose three times with slow, relaxed exhalations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxygen saturation	amount of oxygen traveling through your body with your red blood cells. Changes will be assessed at baseline, 3rd week and 6th weeks measured	Changes will be assessed at baseline, 3rd week and 6th weeks measured
Forced expiratory volume in one second	amount of air expired in first one second. Changes will be assessed at baseline, 3rd week and 6th weeks measured	Changes will be assessed at baseline, 3rd week and 6th weeks measured
Forced vital capacity	the total amount of air exhaled during the FEV test. Changes will be assessed at baseline, 3rd week and 6th weeks measured	Changes will be assessed at baseline, 3rd week and 6th weeks measured
FEV1/FVC ratio	the amount of air exhaled in the first second divided by all of the air exhaled during a maximal exhalation.	6 weeks
shortness of breath measured through borge scale of dyspnea	shortness of breath. Changes will be assessed at baseline, 3rd week and 6th weeks measured	Changes will be assessed at baseline, 3rd week and 6th weeks measured
SGRQ questionnaire	how breathing problems effects quality of life . Changes will be assessed at baseline, 3rd week and 6th weeks measured	Changes will be assessed at baseline, 3rd week and 6th weeks measured

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Wajeeha Zia, MSPT, Riphah International University

Publications and helpful links

General Publications

• Wang G, Hallberg J, Um Bergstrom P, Janson C, Pershagen G, Gruzieva O, van Hage M, Georgelis A, Bergstrom A, Kull I, Linden A, Melen E. Assessment of chronic bronchitis and risk factors in young adults: results from BAMSE. Eur Respir J. 2021 Mar 4;57(3):2002120. doi: 10.1183/13993003.02120-2020. Print 2021 Mar.
• Andelid K, Ost K, Andersson A, Mohamed E, Jevnikar Z, Vanfleteren LEGW, Goransson M. Lung macrophages drive mucus production and steroid-resistant inflammation in chronic bronchitis. Respir Res. 2021 Jun 7;22(1):172. doi: 10.1186/s12931-021-01762-4.
• Samaha E, Vierlinger K, Weinhappel W, Godnic-Cvar J, Nohammer C, Koczan D, Thiesen HJ, Yanai H, Fraifeld VE, Ziesche R. Expression Profiling Suggests Loss of Surface Integrity and Failure of Regenerative Repair as Major Driving Forces for Chronic Obstructive Pulmonary Disease Progression. Am J Respir Cell Mol Biol. 2021 Apr;64(4):441-452. doi: 10.1165/rcmb.2020-0270OC.
• Belman MJ, Thomas SG, Lewis MI. Resistive breathing training in patients with chronic obstructive pulmonary disease. Chest. 1986 Nov;90(5):662-9. doi: 10.1378/chest.90.5.662.
• Kim HK, Alhammouri MT, Mokhtar YM, Pinsky MR. Estimating left ventricular contractility using inspiratory-hold maneuvers. Intensive Care Med. 2007 Jan;33(1):181-9. doi: 10.1007/s00134-006-0443-8. Epub 2006 Nov 14.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: lung infection; resistive breathing; inspiratory hold technique
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration; Acute Disease; Bronchitis; Bronchitis, Chronic
• Other Study ID Numbers: RiphahB Muhammad Makhdoom

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No