NCT05618847

Brief Summary

We are conducting this study to check the effects of active cycle of breathing technique with or without acapella on airway clearance, dyspnea and pulmonary function test in COPD patients. Study design will be randomized controlled trial. Research will be conducted at Aziz Bhatti Shaheed Teaching Hospital and National Hospital Gujrat. Written informed consent will be obtained. Patients will be allocated randomly in two groups. Subjects will meet the predetermined inclusion and exclusion criteria. Questionnaire used as subjective measurements of dyspnea and sputum will be given and pulmonary function test values will be obtained prior to any intervention. One group will receive active cycle of breathing technique and the other group will receive active cycle of breathing technique with acapella device. Every subject will perform supervised ACBTs with and without acapella for four weeks. Three sessions per week will be given with 20 repetitions in two sets. At the end of 4 weeks treatment session, pulmonary function test values will be monitored and questionnaire will be obtained for dyspnea and sputum. Data will be analyzed on SPSS 25

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started May 2022

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

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 16, 2022

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

7 months

First QC Date

November 8, 2022

Last Update Submit

November 8, 2022

Conditions

Keywords

ACBT, Acapella, COPD, PEP

Outcome Measures

Primary Outcomes (3)

  • Sputum diary

    The diary card has a graded symptom score for dyspnea, sputum volume and sputum color. In addition, the card includes a score for patient well-being and documented all minor symptoms (cough, chest pain, cold, or flu-like symptoms)

    4 weeks

  • Dyspnea-MDP scale

    The Multidimensional Dyspnea Profile (MDP) assesses overall breathing discomfort, sensory qualities, and emotional responses

    4 weeks

  • Pulmonary function test

    Pulmonary function tests (PFTS) are an important tool in the investigation and monitoring of patients with respiratory pathology. They provide important information relating to the large and small airways, the pulmonary parenchyma and the size and integrity of the pulmonary capillary bed

    4 weeks

Study Arms (2)

active cycle of breathing technique with acapella

EXPERIMENTAL

Sit up with good posture to use the Acapella. Take in a fairly deep breath and hold it for about 3 seconds. Place the Acapella mouthpiece in your mouth. Seal your lips tightly around the mouthpiece. Exhale as much as possible (but not to forcefully) through the mouthpiece. Keep your cheeks as firm as possible when you exhale. Try not to inhale through the device. Repeat this maneuver for 10 breaths. Try to resist coughing during this phase. After these 10 blows, perform 3 huffs, then a big cough to bring the sputum up and out. Try not to swallow the mucus

Device: Acapella,ACBTSOther: ACBTs

active cycle of breathing technique

ACTIVE COMPARATOR

Ask patient to breathe in and out gently through nose if he/she can. If patient breathe out through their mouth. Ask patient to let go of any tension in body with each breath out. Gradually try to make the breaths slower. Ask patient to take a long, slow, deep breath in, through nose. Try to keep chest and shoulders relaxed. Repeat 3-5 times. Huff is exhaling through an open mouth and throat instead of coughing. It helps move sputum up in airways so that patient can clear it in a controlled way. To 'huff' ask patient to squeeze air quickly from lungs, out through open mouth and throat, as if trying to mist up a mirror or glasses. Ask to use abdominal muscles to help squeeze the air out, but do not force it so much that cause wheezing or tightness in chest. Huffing should always be followed by breathing control.

Other: ACBTs

Interventions

Every subject will perform supervised ACBTs with and without acapella for four weeks. Three sessions per week will be given with 20 repetitions in two sets

active cycle of breathing technique with acapella
ACBTsOTHER

Every subject will perform supervised ACBTs with and without acapella for four weeks. Three sessions per week will be given with 20 repetitions in two sets

active cycle of breathing techniqueactive cycle of breathing technique with acapella

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age:45-75
  • Both genders
  • Mentally stable
  • Diagnosed patients of COPD

You may not qualify if:

  • Any neurological condition
  • Arrythmias
  • Heart failure
  • Previous heart or lung surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aziz bhatti shaheed teaching hospital

Dhok Gujra, Punjab Province, 053, Pakistan

RECRUITING

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

  • Madiha younas, MS

    riphah internationl 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

November 8, 2022

First Posted

November 16, 2022

Study Start

May 1, 2022

Primary Completion

December 1, 2022

Study Completion

February 1, 2023

Last Updated

November 16, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations