NCT06240936

Brief Summary

Chronic Obstructive Pulmonary Disease refers to a group of progressive lung diseases the block air flow and make it difficult to breath. It is potentially fatal and fourth leading cause of death in the world. The symptoms of this condition include shortness of breath, frequent coughing, fatigued and tightness in the chest. Due to the secretions in the lungs sometime patients will have great difficulty catching the breath after walking or exercise. Patient will also feel breathless just sitting or relaxing. Active Cycle of breathing technique can be used to mobilize and clear secretions. It will improve their stamina and reduce the episodes of breathlessness, help to remove the secretions from the lungs and feel better overall. Acapella is a small hand held device which help to loosen and clear secretions from the chest it has both resistive and vibratory features. A randomized control trial will be conducted at Gosha e Shifa hospital and General hospital Lahore through convenience sampling technique on 42 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. Group A will be treated with active cycle of breathing exercises/techniques and Group B will be treated with Acapella device with active cycle of breathing exercise .Outcome measure will be conducted through Modified dyspnea scale, acapella device usage and questionnaire after 4 weeks and also perform Pulmonary function test .Data will be analyzed using SPSS software version 21. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. Acapella device uses and active cycle of breathing technique will be applied for comparing their effect in patients of COPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

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

Timeline
Completed

Started Feb 2024

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

January 28, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

29 days

First QC Date

January 28, 2024

Last Update Submit

April 18, 2024

Conditions

Keywords

COPDACBTsAcapella,breathlessnessfatigue

Outcome Measures

Primary Outcomes (3)

  • Modified Dyspnea scale.

    Data collection tool for shortness of breath is modified dyspnea scale there will be 10 readings. It also accesses breathing discomfort, sensory qualities and emotional distress.

    baseline and fourth week

  • PFTs

    The test will measure the lung volume, and ABGs. It is important tool for the investigation and monitoring of patients with respiratory pathology

    baseline and fourth week

  • Sputum diary BCSS

    In this diary we will check breathlessness, cough and sputum. It also includes the score of patient wellbeing and documented all minor symptoms

    baseline and fourth week

Study Arms (2)

Active cycle of breathing technique

ACTIVE COMPARATOR

ACBTs will be applied on the patients. It consist of the following three phases, breathing control,tboracic expension and forced expiration technique.

Other: Active Cycle of breathing

Active Cycle of breathing with Acapela

EXPERIMENTAL

ACBTs will be applied on the patients. It consist of the following three phases, breathing control,tboracic expension and forced expiration technique. The Acapella device is a handheld device used to help loosen mucus in the lungs. Sit up straight and hold the device in the upright position. Take a deep breath in and seal lips around the mouthpiece. Exhaleforcefully through the mouthpiece, using your stomach muscles to push the air out. Repeat this process several times, taking breaks. After using Acapella cough to clear any mucus that has been loosened. Clean the device after each use.

Other: Active Cycle of breathingOther: Active Cycle of breathing with Acapella

Interventions

Active Cycle of Breathing Techniques will be given to group A. In Active cycle of breathing exercises, breathing control, thoracic expansion and forced expiration technique will be applied. 3-4 sets of exercise ,10-15 mint, 4 times per week for 4 weeks.

Active Cycle of breathing with AcapelaActive cycle of breathing technique

Acapella device will be used along active cycle of breathing techniques to group B. 3-4 sets ,10 mints foe acapella training ,15 -20 munts ,4 times per week for 4 weeks. This technique is active form of therapy in which patient uses its own energy on request to aid in treatment.

Active Cycle of breathing with Acapela

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both men and women age between 35-50 years.
  • Having smoking history .(1)
  • Dyspnea MRC scale grade 2 and grade 3.(20)
  • Gold standard COPD grade 2

You may not qualify if:

  • Any kind of infective pulmonary condition .
  • Restrictive lung disease.(20)
  • Pregnancy.
  • Any severe heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheikh Zayed Hospital,

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (3)

  • Anto JM, Vermeire P, Vestbo J, Sunyer J. Epidemiology of chronic obstructive pulmonary disease. Eur Respir J. 2001 May;17(5):982-94. doi: 10.1183/09031936.01.17509820.

    PMID: 11488336BACKGROUND
  • Vogelmeier CF, Roman-Rodriguez M, Singh D, Han MK, Rodriguez-Roisin R, Ferguson GT. Goals of COPD treatment: Focus on symptoms and exacerbations. Respir Med. 2020 May;166:105938. doi: 10.1016/j.rmed.2020.105938. Epub 2020 Mar 21.

    PMID: 32250871BACKGROUND
  • Lange P, Ahmed E, Lahmar ZM, Martinez FJ, Bourdin A. Natural history and mechanisms of COPD. Respirology. 2021 Apr;26(4):298-321. doi: 10.1111/resp.14007. Epub 2021 Jan 28.

    PMID: 33506971BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspneaFatigue

Condition Hierarchy (Ancestors)

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

Study Officials

  • Madiha Younis, MSPT (CP)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 28, 2024

First Posted

February 5, 2024

Study Start

February 15, 2024

Primary Completion

March 15, 2024

Study Completion

April 15, 2024

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations