NCT05922293

Brief Summary

It will be a randomized control trial. Participants will be recruited according to inclusion criteria and will be allocated into 2 groups using convenience sampling technique. Group 1 will be treated with percussion technique for 30 min and group 2 with blow bottle technique combined with percussion technique for 30 min at DHQ Teaching Hospital Gujranwala. Intervention will be carried out for total 4 weeks of duration with 3 sessions per week. Outcome measures such as dyspnea, breathlessness, sputum and cough, O2 and pulse rate, expiratory flow rate will be measured by tools as mMRC, BCSS, peak flow meter respectively. Assessment will be done before and after intervention and result will be analyzed using statistical package for social sciences SPSS 20.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

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

Timeline
Completed

Started Jun 2023

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

Geographic Reach
1 country

1 active site

Status
completed

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

June 6, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2023

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

June 6, 2023

Last Update Submit

December 26, 2023

Conditions

Keywords

Airway ObstructionCOPDDyspneaExpiratory flow ratePercussion.

Outcome Measures

Primary Outcomes (4)

  • Dyspnea (Modified Medical Research council)

    The mMRC grade is a five-point scale based on the degree of dyspnea a patient. The use of this scale to evaluate symptoms is encouraged by current standards

    fourth week

  • Breathlessness, cough and sputum scale (BCSS)

    In order to give a rapid and simple means of assessing the severity of respiratory symptoms frequent in COPD patients, the Breathlessness, Cough, and Sputum Scale (BCSS) was created. The BCSS is based on a three-item questionnaire that evaluates the patient's sputum production, coughing, and breathlessness

    fourth week

  • Expiratory flow rate (peak flow meter)

    A peak flow rate should be used to capture the highest flow rates. The patient must record the highest reading out of a possible three. The best at the moment is this. A typical chart has dates with AM and PM times, a left margin, and a scale that ranges from 0 litres per minute at the bottom to 600 litres per minute at the top

    fourth week

  • O2 n pulse rate by Oximeter

    A pulse oximeter measures the amount of oxygen that is carried by your blood. Typically, a little clip is attached to the tip of your finger. (On sometimes, the toe or earlobe are used.) A light beam is projected through the skin using the gadget. By measuring the proportion of your blood that is carrying oxygen, it calculates your oxygen level. Your oxygen saturation, often known as SpO2, is displayed on the screen

    fourth week

Study Arms (2)

Blow Bottle technique

ACTIVE COMPARATOR

Blowing with a straw into a water bottle is a good exercise to improve breathing capacity. The user, who has poor pulmonary function, always has his "blow bottle" handy

Other: blow bottle

percussion

EXPERIMENTAL

Percussion technique should be performed for about 30 seconds and simultaneously with no more than three or four lower thoracic expansion exercises

Other: blow bottleOther: percussion

Interventions

When you blow through a tube into water in a bottle, the pressure in the airways increases. This opens up the passageways between bronchioles, allowing air to flow behind the mucus and push it into the larger airways. This way, it will be easy to remove the mucus by coughing or huffing.

Blow Bottle techniquepercussion

Percussion technique should be performed for about 30 seconds and simultaneously with no more than three or four lower thoracic expansion exercises. * Do this for a total of 10 breaths, * Perform two huffs, and * Cough. * Close their mouth around the tube and exhale slightly forcefully for 3 seconds to produce bubbles. Such exhalations were conducted in two sets of ten, with a five-minute pause in between. For each subject, a fresh, disposable tube and bottle were utilized

percussion

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mild-to-Moderate COPD (according to GOLD criteria)
  • Both gender (male and female)
  • Aged between 35 and 80 years

You may not qualify if:

  • Clinically unstable
  • cardiovascular impairment,
  • musculoskeletal dysfunction
  • neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DHQ Teaching Hospital

Gujranwala, Punjab Province, 54560, Pakistan

Location

Related Publications (4)

  • Jones PW, Watz H, Wouters EF, Cazzola M. COPD: the patient perspective. Int J Chron Obstruct Pulmon Dis. 2016 Feb 19;11 Spec Iss(Spec Iss):13-20. doi: 10.2147/COPD.S85977. eCollection 2016.

    PMID: 26937186BACKGROUND
  • Raherison C, Girodet PO. Epidemiology of COPD. Eur Respir Rev. 2009 Dec;18(114):213-21. doi: 10.1183/09059180.00003609.

    PMID: 20956146BACKGROUND
  • 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
  • Celli BR. Update on the management of COPD. Chest. 2008 Jun;133(6):1451-1462. doi: 10.1378/chest.07-2061.

    PMID: 18574288BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAirway ObstructionDyspnea

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sidra Afzal, PP-DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

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 6, 2023

First Posted

June 28, 2023

Study Start

June 15, 2023

Primary Completion

September 15, 2023

Study Completion

December 5, 2023

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations