NCT05922254

Brief Summary

A randomised controlled trial will be conducted with COPD patients as its target population. There will be 40 individuals for both the control group and the intervention group. Group A is a control group while Group B is an experimental group (20 participants on Group A and 20 on group B). The baseline treatment for both groups were pursed lip breathing and ACBT. On the other hand, group B experimental group will also undergo (pursued lip breathing and ACBT) with autogenic drainage. Group A session lasts for 30 minutes and Group B session lasts for 45 minutes. There is only one session per day. There is a three session in a week for 4 weeks. Measurements are made of dyspnea, oxygen saturation, peak expiratory flow rate, pulse rate and fatigue both before and after the treatment, data were recorded. Participants in the trial must have mild to moderate COPD (GOLD Criteria) and be between the ages of 40 to 60 years. Data from Sheikh Zayed Hospital, Rahim Yar Khan will be collected. Follow-up for both completed tasks and changes in pulmonary status will be evaluated after 4 weeks. Modified Borg Dyspnea (RPE) Scale, Breathlessness, Cough and Sputum Scale (BCSS), Fatigue Severity Scale or Visual Analogue Scale, Peak flow meter, Oximeter will be used to measure the outcomes. Data will be analysed using the SPSS 21.0 Statistical Software

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

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

Chronic ObstructiveDrainagePosturalPulmonary DiseaseRespiratory Therapy.

Outcome Measures

Primary Outcomes (6)

  • 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

  • Dyspnea Index Questionnaire

    The Dyspnoea Index questionnaire is a useful tool for quantifying upper airway dyspnea symptoms in patients. It includes 10-item surveys

    fourth week

  • 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). The Breathlessness, Cough and Sputum Scale (BCSS), which assesses common symptoms found in the COPD population, is used to predict patient exacerbations

    fourth week

  • Fatigue Severity Scale

    You can assess the impact of fatigue on you using the Fatigue Severity Scale (FSS). The FSS is a brief questionnaire that asks you to rate how tired you are. Nine statements in the FSS questionnaire allow you to express how severe your tiredness symptoms are

    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

    baseline and fourth week

  • 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. It looks like a little clip and is called a pulse oximeter. It attaches to a body component, usually a finger

    fourth week

Study Arms (2)

Active cycle of breathing technique

ACTIVE COMPARATOR

Group A is a control group. First, the patients will receive baseline treatment (pursed lip breathing). Additionally, patients will be administered the Active Cycle of Breathing Technique after receiving the Baseline Treatment

Other: Active cycle of breathing technique

Autogenic drainage

EXPERIMENTAL

Both the physiotherapist's hand and the subject's hands were put on the subject's abdomen to feel the activity of the abdominal muscles. The patient inhaled slowly through the nose while using their diaphragm and holding their breath for two to three seconds to allow collateral ventilation to bring air behind their secretions. Exhalation was done through the mouth. The palm of the therapist placed on the upper chest felt the vibration of the mucous. Their positions were disclosed by the vibrations' frequency. Secretions in tiny airways can be seen using high frequencies. The method has phases for unsticking, collecting and evacuation. The mucus was expelled by a stronger expiration or a high lung volume huff at the conclusion of the session.

Other: Active cycle of breathing techniqueOther: Autogenic drainage

Interventions

The ACBT technique consists of three different breathing techniques: breathing control, thoracic expansion exercises and forced expiration technique. 1. Breathing Control 2. Thoracic Expansion Exercises: 3. Forced Expiration Technique:

Active cycle of breathing techniqueAutogenic drainage

Huffing or blowing the nose helped to get rid of any secretions in the upper airways. The therapist was placed close enough to hear the subject's breathing while sitting to the side and slightly behind the patient. Both the physiotherapist's hand and the subject's hands were put on the subject's abdomen to feel the activity of the abdominal muscles. The patient inhaled slowly through the nose while using their diaphragm and holding their breath for two to three seconds to allow collateral ventilation to bring air behind their secretions. Exhalation was done through the mouth. The palm of the therapist placed on the upper chest felt the vibration of the mucous. Their positions were disclosed by the vibrations' frequency.

Autogenic drainage

Eligibility Criteria

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

You may qualify if:

  • Both genders (Male and Female)
  • Age 40 to 60 years
  • Mild to moderate COPD (According to GOLD Criteria)
  • Patient is bilingual.

You may not qualify if:

  • Patients having progressive respiratory muscle weakness (Mysthenia Gravis)
  • Cardiovascular impairment
  • Any recent surgery
  • Systemic illness
  • Angina
  • Uncontrolled diabetes and hypertension
  • Non-cooperative Patients

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 (3)

  • Yadav UN, Lloyd J, Hosseinzadeh H, Baral KP, Harris MF. Do Chronic Obstructive Pulmonary Diseases (COPD) Self-Management Interventions Consider Health Literacy and Patient Activation? A Systematic Review. J Clin Med. 2020 Feb 28;9(3):646. doi: 10.3390/jcm9030646.

    PMID: 32121180BACKGROUND
  • Garcia-Aymerich J, Lange P, Benet M, Schnohr P, Anto JM. Regular physical activity reduces hospital admission and mortality in chronic obstructive pulmonary disease: a population based cohort study. Thorax. 2006 Sep;61(9):772-8. doi: 10.1136/thx.2006.060145. Epub 2006 May 31.

    PMID: 16738033BACKGROUND
  • Mendes LP, Moraes KS, Hoffman M, Vieira DS, Ribeiro-Samora GA, Lage SM, Britto RR, Parreira VF. Effects of Diaphragmatic Breathing With and Without Pursed-Lips Breathing in Subjects With COPD. Respir Care. 2019 Feb;64(2):136-144. doi: 10.4187/respcare.06319. Epub 2018 Aug 28.

    PMID: 30154127BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveLung Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveRespiratory 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