Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05533931
Other study ID # RiphahB Muhammad Makhdoom
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2022
Est. completion date September 2022

Study information

Verified date September 2022
Source Riphah International University
Contact Ghazal Jamshaid, MS CPPT
Phone 03040404851
Email ghazaljamshaid141@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 26
Est. completion date September 2022
Est. primary completion date September 2022
Accepts healthy volunteers No
Gender All
Age group 45 Years to 60 Years
Eligibility 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 Design


Intervention

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
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

Locations

Country Name City State
Pakistan Mayo hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

Andelid K, Öst K, Andersson A, Mohamed E, Jevnikar Z, Vanfleteren LEGW, Göransson 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. — View Citation

Belman MJ, Thomas SG, Lewis MI. Resistive breathing training in patients with chronic obstructive pulmonary disease. Chest. 1986 Nov;90(5):662-9. — View 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. Epub 2006 Nov 14. — View Citation

Samaha E, Vierlinger K, Weinhappel W, Godnic-Cvar J, Nöhammer 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. — View Citation

Wang G, Hallberg J, Um Bergström P, Janson C, Pershagen G, Gruzieva O, van Hage M, Georgelis A, Bergström A, Kull I, Lindén A, Melén E. Assessment of chronic bronchitis and risk factors in young adults: results from BAMSE. Eur Respir J. 2021 Mar 4;57(3). pii: 2002120. doi: 10.1183/13993003.02120-2020. Print 2021 Mar. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT01420445 - Safety/Tolerability and Efficacy of YHD001 in Patients With Acute and Chronic Bronchitis Phase 2
Completed NCT01071161 - The Effect of Azithromycin in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Productive Cough Phase 3
Completed NCT00903955 - Mucus Dehydration and Evolution of Chronic Obstructive Pulmonary Disease (COPD) Lung Disease N/A
Terminated NCT00524095 - Bronchiectasis in Chronic Obstructive Pulmonary Disease (COPD) Patients: Role of Prophylaxis Phase 2
Completed NCT00129883 - Adherence to Guidelines for Antibiotic Use in Respiratory Infections at Hospitals N/A
Recruiting NCT05075083 - Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Elderly People With Chronic Bronchitis and COPD Phase 4
Recruiting NCT05075057 - Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Patients Aged ≥60 Years With Chronic Bronchitis and COPD Phase 4
Terminated NCT02838108 - The Relationship Between GOLD Risk Group and Clinical Outcomes in a Community-based COPD Cohort
Completed NCT02128529 - Epidemiology of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease (COPD) N/A
Withdrawn NCT00298402 - Macrophages in Smokers' Lung N/A
Completed NCT00298389 - Macrophage Phagocytosis in COPD
Terminated NCT00132951 - KEYS: Study Comparing Clinical Health Outcomes of Telithromycin Versus Azithromycin in Outpatients With Community-acquired Lower Respiratory Tract Infections Phase 4
Active, not recruiting NCT01969344 - Study of COPD Subgroups and Biomarkers
Completed NCT00680056 - Add-on Effects of Tiotropium Over Formoterol in Exercise Tolerance on Chronic Obstructive Pulmonary Disease Patients Phase 4
Completed NCT00106080 - Improving the Quality of End-of-Life Communication for Patients With Chronic Obstructive Pulmonary Disease (COPD) N/A
Completed NCT00042718 - A Study of the Effectiveness and Safety of High Dose, Short-course Levofloxacin in the Treatment of Acute Bacterial Exacerbation (Worsening) of Chronic Bronchitis. Phase 3
Completed NCT02099799 - The Effect of Physical Activity Promotion on Short and Long-term Outcomes in COPD N/A
Completed NCT00342030 - Dietary and Genetic Factors in Asthma & Chronic Bronchitis in a Cohort of Chinese Singaporeans N/A
Withdrawn NCT02341183 - Novel Therapies for Muco-Obstructive Lung Diseases: Testing the Transnasal Pulmonary Delivery Device in COPD/CB Subjects N/A
Completed NCT00876577 - VICTOR - Avelox® Intravenous (i.v.) in Acute Exacerbations of Chronic Bronchitis N/A