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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06240936
Other study ID # REC/RCR&AHS/23/0339
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2024
Est. completion date April 15, 2024

Study information

Verified date April 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date April 15, 2024
Est. primary completion date March 15, 2024
Accepts healthy volunteers No
Gender All
Age group 35 Years to 50 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Any kind of infective pulmonary condition . - Restrictive lung disease.(20) - Pregnancy. - Any severe heart disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Active Cycle of breathing
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 Acapella
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.

Locations

Country Name City State
Pakistan Sheikh Zayed Hospital, Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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