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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06444971
Other study ID # FUI/CTR/2024/8
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 7, 2023
Est. completion date June 27, 2024

Study information

Verified date June 2024
Source Foundation University Islamabad
Contact Huma Masood, MS-MSKPT*
Phone 03485289948
Email humakhalid603@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of the study was to investigate the immediate effects of PIR technique on chest expansion and pulmonary functions in cigarette smokers.This quasi-experimental pre-test post-test study will be conducted. Participants of interest would be approached and explained about the research. Informed written consent will be taken. Recruited participants will receive PIR technique on assessory respiratory muscles and chest expansion and pulmonary function tests will be obtained before and after the treatment. Data collection tools for this study are spirometer and measuring tape.


Description:

Tobacco use, particularly cigarette smoking, is a major cause of disease and death globally. In Pakistan, the prevalence of tobacco use has increased significantly, with men being more likely to smoke than women. Chronic smoking is strongly associated with cardiovascular and respiratory diseases, as well as various forms of cancer. Smoking negatively affects lung function, leading to reduced pulmonary capacity and chronic obstructive pulmonary disease. Additionally, long-term smoking may lead to the loss of respiratory capacity and systemic muscle mass, affecting the performance and work of breathing. The primary objective of the study was to investigate the effects of PIR technique on chest expansion and pulmonary functions in cigarette smokers. This quasi-experimental pre-test post-test study will be conducted over one year at FFH, FUSH and among the general public. A sample will be calculated through pilot study. Participants between the ages of 18-60 will be recruited using convenience sampling. Inclusion criteria included individuals with min of 2 pack-years of tobacco smoking, while exclusion criteria included patients with certain cardiopulmonary medical conditions and those who underwent surgery or physiotherapy within past few months. Data collection tools for this study are spirometer and measuring tape. There is little to no literature on the effects of PIR technique on chest expansion and pulmonary functions in cigarette smokers. The immediate effects of PIR technique demonstrated in this study will provide physical therapists with valuable insight into its use as a treatment option for smokers to improve their pulmonary function. Moreover, this study adds to the existing literature on manual therapy and its effects on smokers. The findings of this study will provide a basis for future research in the field of musculoskeletal rehabilitation and will encourage future researchers to explore this area further.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date June 27, 2024
Est. primary completion date June 25, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Individuals between the ages of 18-60 - Only tobacco cigarette smokers - Cigarette smokers (with min 2 pack years ) - Both males and females Exclusion Criteria: - Patients undergoing any surgery - Symptomatic patients of cystic fibrosis, asthma, exercise induced asthma, unstable angina, bronchitis , bronchiectasis, chest deformities, congenital cardiopulmonary disorders , disc herniation, current rib or vertebral fracture - Patients with a positive history of trauma, fracture or surgery of the cervical and thoracic spine in the last 12 months

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Post isometric Relaxation
Post isometric relaxation technique: It is defined as a manual procedure which involves the precisely controlled and specifically directed active contraction of a muscle at varying levels of intensity against a counterforce applied by the therapist. PIR will be applied to following muscles scalene (anterior, middle and posterior) sternocleidomastoid

Locations

Country Name City State
Pakistan Foundation University College of Physical Therapy Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Chest expansion Measuring tape will be used to measure chest expansion at axillary level. Immediate after treatment
Primary Forced Vital Capacity(FVC) the maximum amount of air you can forcibly exhale from your lungs after fully inhaling measured using hand held spirometer Immediate after treatment
Primary Forced Expiratory Volume in 1 second (FEV1) The volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration measured using hand held spirometer. Immediate after treatment
Primary Peak Expiratory Flow (PEF) the volume of air forcefully expelled from the lungs in one quick exhalation measured using hand held spirometer Immediate after treatment
Primary FEV1/ FVC The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lung measured using hand held spirometer Immediate after treatment
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