Combined Effects of Blow Bottle Device and Postural Drainage in Moderate to Severe Elderly COPD Patients

It will be a randomized clinical trial. Age of selected subjects will be between 40 to 70 years. Data will be collected from Wazirabad institute of cardiology. There will be 2 groups i.e. group A will receive combination of blow bottle technique and postural drainage and group B will receive postural drainage. Spirometer will be used to evaluate pulmonary functions and breathless, cough and sputum scale (BCSS) will be used to evaluate the improvement in sputum diary of patients. Interventions will be given to the patients for 20-25 minutes twice a day for 6 days per week. After data collection, data will be analyzed using SPSS version 25.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: blow bottle technique; Other: percussion

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Imran Amjad, PhD; Phone Number: 03324390125; Email: Imran.amjad@riphah.edu.pk
• Study Contact Backup: Name: Iqbal Tariq, PHD; Phone Number: O3338236752; Email: iqbal.tariq@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Multān, Punjab, Pakistan, 54000
      • Recruiting
      • Wazirabad Institute of Cardiology
      • Contact: Sidra Faisal, MS.CPPT; Phone Number: 03022001847; Email: sidra.faisal@riphah.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Diagnosed moderate to severe GOLD (2017) COPD
• 40-60 years old
• Both male and female
• Patients hemodynamically stable
• PFT showing irreversible airflow limitation.

Exclusion Criteria:

• Type II diabetic mellitus
• Systemic illness
• Thoracic deformation or rib fracture.
• Pulmonale decompensation and signs of an unstable heart condition.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: blow bottle technique; There were 20 patients in group A received blow bottle device and postural drainage for 20- 25 minutes per session twice a day for 4 days per week, for 8 weeks.	Other: blow bottle technique; There were 20 patients in group A received blow bottle device and postural drainage for 20- 25 minutes per session twice a day for 4 days per week, for 8 weeks.; Other Names: postural drainage
Active Comparator: percussion; There were 20 patients in group B received postural drainage with percussion for 20- 25 minutes per session twice a day for 4 days per week, for 8 weeks.	Other: percussion; Group B: There were 20 patients in group B received postural drainage with percussion for 20- 25 minutes per session twice a day for 4 days per week, for 8 weeks.; Other Names: postural drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breathlessness cough sputum scale	Breathlessness, Cough and Sputum scale (BCSS) was developed to effectively measure the severity of respiratory symptoms. The BCSS records symptoms in a 5-point Likert like scale in which zero represents improvement symptoms and scores towards 4 indicating worsening of symptoms. It is commonly used in patients with COPD. BCSS provides a simple and robust quantification of symptoms that is sensitive to the effects of treatment and could therefore be used to assess therapeutic interventions. It has good reliability and validity for use in patients with respiratory disorders.	4 weeks
Modified borg RPE scale:	The Modified Borg Dyspnea Scale (MBS) is rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise, one of the most common and frequently used measures to assess the severity of dyspnea.	4 weeks
Incentive spirometry	Incentive spirometry is frequently used after thoracic surgery as an adjunct to physiotherapy. Despite its widespread use, it has remained challenging to demonstrate a clinical benefit in terms of either incidence of pulmonary complications or hospital stay.	4 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Sidra Faisal, MS.CPPT, Riphah International University

Publications and helpful links

General Publications

• Kullowatz A, Kanniess F, Dahme B, Magnussen H, Ritz T. Association of depression and anxiety with health care use and quality of life in asthma patients. Respir Med. 2007 Mar;101(3):638-44. doi: 10.1016/j.rmed.2006.06.002. Epub 2006 Aug 7.
• Goodwin RD, Eaton WW. Asthma and the risk of panic attacks among adults in the community. Psychol Med. 2003 Jul;33(5):879-85. doi: 10.1017/s0033291703007633.
• Wright RJ, Rodriguez M, Cohen S. Review of psychosocial stress and asthma: an integrated biopsychosocial approach. Thorax. 1998 Dec;53(12):1066-74. doi: 10.1136/thx.53.12.1066.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): July 10, 2024
• Study Completion (Estimated): July 15, 2024

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Dyspnea; Postural drainage
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: REC/RCR & AHS/23/0376

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No