Clinical trial NCT05533931: Resistive Breathing Versus Inspiratory Hold Technique in Patients With Chronic Bronchitis
Official title: Comparison of Resistive Breathing Versus Inspiratory Hold Technique in Patients With Chronic Bronchitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Bronchitis
Keywords: lung infection
resistive breathing
inspiratory hold technique
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 26
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: oxygen saturation
timeFrame: Changes will be assessed at baseline, 3rd week and 6th weeks measured
measure: Forced expiratory volume in one second
timeFrame: Changes will be assessed at baseline, 3rd week and 6th weeks measured
measure: Forced vital capacity
timeFrame: Changes will be assessed at baseline, 3rd week and 6th weeks measured
measure: FEV1/FVC ratio
timeFrame: 6 weeks
measure: shortness of breath measured through borge scale of dyspnea
timeFrame: Changes will be assessed at baseline, 3rd week and 6th weeks measured
measure: SGRQ questionnaire
timeFrame: Changes will be assessed at baseline, 3rd week and 6th weeks measured
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Mayo hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Wajeeha Zia, MSPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.