NCT05922241

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory lung disease that causes obstructed airflow from the lungs. Symptoms include breathing difficulty, cough, mucus (sputum) production and wheezing. In Costophrenic assist, the therapist gives a quick stretch to the diaphragm and intercostals with repetitions. The patientt holds air in the lungs. As the patient gets ready to cough, the therapist performs a diaphragmatic assist. In Anterior chest compression: the therapist places one arm across the patient's pectorals and the other parallel to it. After the patient takes a maximal breath, the therapist pushes down to help the patient cough. The greatest force is applied through the lower chest during expulsion. A total 34 patients will be taken. 2 groups will be created to apply intervention. After signing consent form, 17 patients in group A will be given costophrenic assist technique and 17 patients in group B will be given anterior chest compression technique. Baseline treatment given to both groups will include percussion and tapping. The data collected will then be analyzed using IBM SPSS version 25

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

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

Anterior chest compressionChest PhysioCostophrenic assistSputum expectorationOxygen Saturation

Outcome Measures

Primary Outcomes (4)

  • Breathlessness, Cough and Sputum Scale (BCSS)

    The breathlessness, cough and sputum scale (BCSS) are a three-item scale that rates symptoms of dyspnea, cough and sputum on a Likert scale from 0 (no symptoms) to 4 (severe symptoms)

    fourth week

  • Modified Borg Dyspnea (RPE) scale

    The most popular tool for evaluating symptoms of breathlessness is the Modified Borg Dyspnoea Scale. RPE scales, despite being a subjective gauge of exercise intensity, are useful when utilised properly. The RPE scale has a 0 to10 scale with 0 being no exertion and 10 being maximum effort

    fourth week

  • Peak Flow Meter

    A peak flow meter must be used by blowing forcefully into it. In liters per minute, the meter measures the forced air flow. When you exhale, the indicator on the device moves and gives you a reading on a scale of 1 to 10. When a person's airway function changes, it may be a sign that their asthma or COPD symptoms are getting worse. This is where a peak flow meter is useful

    fourth week

  • Pulse Oximeter:

    The oxygen saturation level of your blood can be measured with a non-invasive procedure called pulse oximetry. It can quickly identify even minute variations in oxygen levels. These levels demonstrate how well blood transports oxygen to your arms and legs, which are the extremities that are farthest from your heart

    fourth week

Study Arms (2)

Costophrenic assisted cough

EXPERIMENTAL

While doing Costophrenic assist: at the end of expiration, the therapist gives a quick stretch to the diaphragm and intercostals to facilitate more complete inhalation by compressing the chest at the costophrenic angle toward the central tendon of the diaphragm. This is done several times to fill the lungs. The patient is then instructed to hold the air in the lungs. As the patient gets ready to cough, the therapist performs a diaphragmatic assist by applying a strong pressure up and in toward the central tendon

Other: Costophrenic assisted cough

Anterior chest compression

EXPERIMENTAL

Anterior chest compression: the therapist places one arm across the patient's pectorals and the other parallel to it on the lower abdomen. After the patient takes a maximal breath, the therapist pushes down to help the patient cough. The greatest force is applied through the lower chest during expulsion

Other: Anterior chest compression

Interventions

Therapist places the hands on the costophrenic angles of the patient's rib cage. During the patient's inspiration, the therapist applies a series of three repeated quick-stretch contractions down and in to encourage maximal inspiration. At the end of expiration, the therapist applies a quick stretch down and in on the patient's lower chest to facilitate a stronger diaphragmatic and intercostal muscle contraction. While instructing the patient to cough, the therapist applies strong pressure through the hands in toward the central tendon of the patient's diaphragm

Costophrenic assisted cough

The therapist puts one arm across the patient's pectoral region to stabilize or compress the upper chest while the other arm is placed either parallel on the lower chest or abdomen below the xiphoid process

Anterior chest compression

Eligibility Criteria

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

You may qualify if:

  • Stable Patients
  • Mild to Moderate Patients of COPD according to gold criteria
  • Decreased O2 Saturation Levels
  • Immobilized Mucus

You may not qualify if:

  • Tachycardia
  • Tachypnea
  • Non Covid
  • Cardiovascular Pathology
  • Myopathy
  • Neurogenic Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheikh Zayed Hospital,

Rahim Yar Khan, Punjab Province, 64200, Pakistan

Location

Related Publications (4)

  • 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
  • Lopez-Campos JL, Calero C, Quintana-Gallego E. Symptom variability in COPD: a narrative review. Int J Chron Obstruct Pulmon Dis. 2013;8:231-8. doi: 10.2147/COPD.S42866. Epub 2013 May 7.

    PMID: 23687444BACKGROUND
  • Arık S, Çevik K. Effect of Postural Drainage and Deep Breathing-Cough Exercises on Oxygen Saturation, Triflo Volume and Pulmonary Function Test in Patients with COPD. Journal of Clinical & Experimental Investigations. 2021;12(4).

    BACKGROUND
  • Ramos FL, Krahnke JS, Kim V. Clinical issues of mucus accumulation in COPD. Int J Chron Obstruct Pulmon Dis. 2014 Jan 24;9:139-50. doi: 10.2147/COPD.S38938. eCollection 2014.

    PMID: 24493923BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs 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