NCT05533931

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2022

Completed
Last Updated

September 9, 2022

Status Verified

September 1, 2022

Enrollment Period

Same day

First QC Date

July 14, 2022

Last Update Submit

September 8, 2022

Conditions

Chronic Bronchitis

Keywords

lung infectionresistive breathinginspiratory hold technique

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (2)

Resistive Breathing Training group

EXPERIMENTAL

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

inspiratory hold technique

ACTIVE COMPARATOR

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

Interventions

Resistive Breathing Training groupOTHER

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

Resistive Breathing Training group
inspiratory hold techniqueOTHER

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

inspiratory hold technique

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Presence of any genetic disorders (cystic fibrosis).
  • Recent spinal / chest surgery
  • Cardiac issues
  • Fractures of vertebra caused by osteoporosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo hospital

Lahore, Punjab Province, 53700, Pakistan

Location

Related Publications (5)

  • 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.

    PMID: 33184115BACKGROUND

  • 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.

    PMID: 34098956BACKGROUND

  • 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.

    PMID: 33524306BACKGROUND

  • 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.

    PMID: 3769566BACKGROUND

  • 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.

    PMID: 17103142BACKGROUND

MeSH Terms

Conditions

Bronchitis, Chronic

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesPulmonary Disease, Chronic ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wajeeha Zia, MSPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghazal Jamshaid, MS CPPT

CONTACT

03040404851ghazaljamshaid141@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2022

First Posted

September 9, 2022

Study Start

September 1, 2022

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

September 9, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)