NCT06476769

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

January 15, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 26, 2024

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 12, 2024

Last Update Submit

June 24, 2024

Conditions

Keywords

DyspneaPostural drainage

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

blow bottle technique

EXPERIMENTAL

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

percussion

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: postural drainage
blow bottle technique

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.

Also known as: postural drainage
percussion

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wazirabad Institute of Cardiology

Multan Khurd, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (3)

  • 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.

    PMID: 16891108BACKGROUND
  • 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.

    PMID: 12877402BACKGROUND
  • 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.

    PMID: 10195081BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Interventions

Drainage, Postural

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DrainageTherapeuticsPhysical Therapy ModalitiesRehabilitationRespiratory Therapy

Study Officials

  • Sidra Faisal, MS.CPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

June 12, 2024

First Posted

June 26, 2024

Study Start

January 15, 2024

Primary Completion

July 10, 2024

Study Completion

July 15, 2024

Last Updated

June 26, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations