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Resistive Breathing Versus Inspiratory Hold Technique in Patients With Chronic Bronchitis

Primary Purpose

Chronic Bronchitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Resistive Breathing Training group
inspiratory hold technique
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Bronchitis focused on measuring lung infection, resistive breathing, inspiratory hold technique

Eligibility Criteria

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

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.

Sites / Locations

  • Mayo hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Resistive Breathing Training group

inspiratory hold technique

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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
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
FEV1/FVC ratio
the amount of air exhaled in the first second divided by all of the air exhaled during a maximal exhalation.
shortness of breath measured through borge scale of dyspnea
shortness of breath. 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

Secondary Outcome Measures

Full Information

First Posted
July 14, 2022
Last Updated
September 8, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05533931
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

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
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Bronchitis
Keywords
lung infection, resistive breathing, inspiratory hold technique

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Resistive Breathing Training group
Arm Type
Experimental
Arm Description
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
Arm Title
inspiratory hold technique
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Resistive Breathing Training group
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
inspiratory hold technique
Intervention Description
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
Primary Outcome Measure Information:
Title
oxygen saturation
Description
amount of oxygen traveling through your body with your red blood cells. Changes will be assessed at baseline, 3rd week and 6th weeks measured
Time Frame
Changes will be assessed at baseline, 3rd week and 6th weeks measured
Title
Forced expiratory volume in one second
Description
amount of air expired in first one second. Changes will be assessed at baseline, 3rd week and 6th weeks measured
Time Frame
Changes will be assessed at baseline, 3rd week and 6th weeks measured
Title
Forced vital capacity
Description
the total amount of air exhaled during the FEV test. Changes will be assessed at baseline, 3rd week and 6th weeks measured
Time Frame
Changes will be assessed at baseline, 3rd week and 6th weeks measured
Title
FEV1/FVC ratio
Description
the amount of air exhaled in the first second divided by all of the air exhaled during a maximal exhalation.
Time Frame
6 weeks
Title
shortness of breath measured through borge scale of dyspnea
Description
shortness of breath. Changes will be assessed at baseline, 3rd week and 6th weeks measured
Time Frame
Changes will be assessed at baseline, 3rd week and 6th weeks measured
Title
SGRQ questionnaire
Description
how breathing problems effects quality of life . Changes will be assessed at baseline, 3rd week and 6th weeks measured
Time Frame
Changes will be assessed at baseline, 3rd week and 6th weeks measured

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ghazal Jamshaid, MS CPPT
Phone
03040404851
Email
ghazaljamshaid141@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wajeeha Zia, MSPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
53700
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wajeeha Zia, MSPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33184115
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.
Results Reference
background
PubMed Identifier
34098956
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.
Results Reference
background
PubMed Identifier
33524306
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.
Results Reference
background
PubMed Identifier
3769566
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.
Results Reference
background
PubMed Identifier
17103142
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.
Results Reference
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Resistive Breathing Versus Inspiratory Hold Technique in Patients With Chronic Bronchitis

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