NCT06189196

Brief Summary

Chronic obstructive pulmonary disease is a common disease worldwide. Pulmonary rehabilitation is an important part to decrease the complications of COPD. Blow bottle technique is an economical and subjective technique promote the lung expansion, as compare to ACBTs. It used to treat the different complications in COPD patients and also decrease the dependency of patient. To find the comparative effects of blow bottle and active cycle of breathing on sputum diary, oxygen saturation, pulmonary function and quality of life among the patients of chronic bronchitis. A randomized clinical trial will be conducted at Gulab Devi hospital Lahore. Through convenient sampling technique on 56 patients, allocated through simple random sampling through computer generated technique into group A and Group B. Group A will be treated with blow bottle technique and group B will be treated by with ACBTs. Pretreatment values will be recorded for BCSS for sputum, pulse oximeter, pulmonary function test and st. George for quality of life will be assessed before and after 8 weeks of the treatment. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be use within a group or between two groups.

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
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

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

August 18, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

August 18, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
Last Updated

January 3, 2024

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

August 18, 2023

Last Update Submit

December 19, 2023

Conditions

Keywords

Active cycle of breathing techniqueBreathlessnessCoughChronic Obstructive Pulmonary Disease,SputumQuality Of Life

Outcome Measures

Primary Outcomes (1)

  • Breathlessness, Cough and Sputum Scale (BCSS).

    This scale is used to measure severity of breathlessness, cough and sputum. It is consist of 5 levels 0 to 4. In which 0 means unaware of difficulty,1 means mild,2 means moderate, 3 means marked and 4 means severe difficulty.

    5thy day

Study Arms (2)

Group A

EXPERIMENTAL

BLOW BOTTLE

Device: BLOW BOTTLE

Group B

EXPERIMENTAL

ACBT

Other: ACBT

Interventions

Blow Bottle PEP' is the cost-effective device comparative to other PEP devices. Treatment (CPT) along with BBPEP twice a day. Therapist made a cost-effective BBPEP which generates 10 cm of H2O PEP and it was given for 10 breaths, 3 sets with 5 second hold.

Group A
ACBTOTHER

Active cycle of breathing technique (ACBT) is an alternative airway clearance technique. A typical ACBT cycle consists of breathing control, three to four thoracic expansion exercises, and a forced expiratory technique (huffing). ACBT has been shown to improve short-term secretion clearance in patients with chronic lung disease. It is also flexible, tolerated, and accepted well by patients. Although ACBT is widely used in patients with respiratory conditions characterized by chronic sputum production.

Group B

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate COPD
  • Hx of chronic sputum production
  • Regular expectoration
  • After 48 hours of admission in hospital
  • Patient of 45 to 65 years
  • Both genders (male and female)

You may not qualify if:

  • Pulmonary disease like, Bronchiectasis, pneumothorax, TB, atelectasis
  • Lung Abscess
  • Lung cancer
  • Any post-surgical (pneumectomy, lobectomy)
  • Hemoptysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulab Devi Hospital

Lahore, Punjab Province, 5400, Pakistan

RECRUITING

Related Publications (17)

  • Petty TL. The history of COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(1):3-14. doi: 10.2147/copd.2006.1.1.3.

    PMID: 18046898BACKGROUND
  • Gerayeli FV, Milne S, Cheung C, Li X, Yang CWT, Tam A, Choi LH, Bae A, Sin DD. COPD and the risk of poor outcomes in COVID-19: A systematic review and meta-analysis. EClinicalMedicine. 2021 Mar;33:100789. doi: 10.1016/j.eclinm.2021.100789. Epub 2021 Mar 18.

    PMID: 33758801BACKGROUND
  • Brashier BB, Kodgule R. Risk factors and pathophysiology of chronic obstructive pulmonary disease (COPD). J Assoc Physicians India. 2012 Feb;60 Suppl:17-21. No abstract available.

    PMID: 23155808BACKGROUND
  • Adeloye D, Song P, Zhu Y, Campbell H, Sheikh A, Rudan I; NIHR RESPIRE Global Respiratory Health Unit. Global, regional, and national prevalence of, and risk factors for, chronic obstructive pulmonary disease (COPD) in 2019: a systematic review and modelling analysis. Lancet Respir Med. 2022 May;10(5):447-458. doi: 10.1016/S2213-2600(21)00511-7. Epub 2022 Mar 10.

    PMID: 35279265BACKGROUND
  • Kamal R, Srivastava AK, Kesavachandran CN, Bihari V, Singh A. Chronic obstructive pulmonary disease (COPD) in women due to indoor biomass burning: a meta analysis. Int J Environ Health Res. 2022 Jun;32(6):1403-1417. doi: 10.1080/09603123.2021.1887460. Epub 2021 Feb 12.

    PMID: 33573386BACKGROUND
  • Rajnoveanu AG, Rajnoveanu RM, Motoc NS, Postolache P, Gusetu G, Man MA. COPD in Firefighters: A Specific Event-Related Condition Rather than a Common Occupational Respiratory Disorder. Medicina (Kaunas). 2022 Feb 5;58(2):239. doi: 10.3390/medicina58020239.

    PMID: 35208563BACKGROUND
  • Halbert RJ, Isonaka S, George D, Iqbal A. Interpreting COPD prevalence estimates: what is the true burden of disease? Chest. 2003 May;123(5):1684-92. doi: 10.1378/chest.123.5.1684.

    PMID: 12740290BACKGROUND
  • Medrinal C, Bonnevie T. [Physiotherapy during and after acute exacerbation of COPD]. Rev Mal Respir. 2022 Apr;39(4):386-397. doi: 10.1016/j.rmr.2022.02.056. Epub 2022 Feb 24. French.

    PMID: 35221161BACKGROUND
  • Mansha H, Rashid S, Khalid MU, Khan RR, Hassan M, Khalid H. Effects of Active Cycle of Breathing Techniques on quality of life in patients with Chronic Bronchitis. Foundation University Journal of Rehabilitation Sciences. 2022;2(2):40-5.

    BACKGROUND
  • Liu H, Zhang X, Zhang Y. [Design and application of a pulmonary function exercise bottle]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2019 Feb;31(2):236-237. doi: 10.3760/cma.j.issn.2095-4352.2019.02.023. Chinese.

    PMID: 30827317BACKGROUND
  • Zisi D, Chryssanthopoulos C, Nanas S, Philippou A. The effectiveness of the active cycle of breathing technique in patients with chronic respiratory diseases: A systematic review. Heart Lung. 2022 May-Jun;53:89-98. doi: 10.1016/j.hrtlng.2022.02.006. Epub 2022 Feb 27.

    PMID: 35235877BACKGROUND
  • Hichkad S, Ganesh B. Effect of blow bottle device and flutter on functional capacity, dyspnea, fatigue, and peak expiratory flow rate in mild-to-moderate COPD patients: A comparative study. Indian Journal of Respiratory Care. 2021;10(3):294.

    BACKGROUND
  • Pakpahan R, Tarigan AP. The Effect of the Combination of Chest Physiotherapy and Active Cycle Breathing Technique on Respiratory Rate and Ability to Expend Sputum in Chronic Exacerbation Obstructive Lung Disease Patients at Haji Adam Malik Hospital Medan. European Journal of Molecular & Clinical Medicine. 2021;8(3):616-23.

    BACKGROUND
  • Zuriati Z, Surya M. Effectiveness Active Cycle of Breathing Technique (ACBT) with Pursed Lips Breathing Technique (PLBT) to tripod position in increase oxygen saturation in patients with COPD, West Sumatera. Enfermeria Clinica. 2020;30:164-7.

    BACKGROUND
  • Shen M, Li Y, Ding X, Xu L, Li F, Lin H. Effect of active cycle of breathing techniques in patients with chronic obstructive pulmonary disease: a systematic review of intervention. Eur J Phys Rehabil Med. 2020 Oct;56(5):625-632. doi: 10.23736/S1973-9087.20.06144-4. Epub 2020 May 13.

    PMID: 32397703BACKGROUND
  • Gulati M, Singh K, Yadav H, Kumar S, Verma A. An Immediate Effect of Conventional Physiotherapy versus ACBT with Autogenic Drainage on Dyspnoea and Cough in Patient with COPD-A Randomized Control Trial.

    BACKGROUND
  • Katke S, Anthikat M. Comparative Study of Flutter Device and Active Cycle of Breathing Technique in Airway Clearance in Subjects with Chronic Obstructive Pulmonary Disease. Website: www ijpot com. 2020;14(3):232.

    BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspneaCough

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Wajeeha Zia, phd*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2023

First Posted

January 3, 2024

Study Start

August 18, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

January 3, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations