NCT06444971

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 7, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2024

Completed
Last Updated

June 6, 2024

Status Verified

June 1, 2024

Enrollment Period

1.3 years

First QC Date

May 27, 2024

Last Update Submit

June 5, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • Chest expansion

    Measuring tape will be used to measure chest expansion at axillary level.

    Immediate after treatment

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

PIR Group

EXPERIMENTAL

Post isometric relaxation technique will be applied to sternocleidomastoid and scalene muscles in all the participants with following parameters * Participant will perform isometric contractions using 20 -30% of their strength * HOLD TIME: 5-7 sec followed by 20 to 30 sec stretch * REST TIME: 5 sec * REPETITIONS: 3-5 repetitions

Procedure: Post isometric Relaxation

Interventions

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 1. scalene (anterior, middle and posterior) 2. sternocleidomastoid

PIR Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals between the ages of 18-60
  • Only tobacco cigarette smokers
  • Cigarette smokers (with min 2 pack years )
  • Both males and females

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Tobacco Smoking

Condition Hierarchy (Ancestors)

SmokingBehaviorTobacco Use

Central Study Contacts

Huma Masood, MS-MSKPT*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This study is a quasi pre test post test study with a single group. Participants will be recruited according to inclusion criteria .Each participant will receive same treatment .
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2024

First Posted

June 6, 2024

Study Start

March 7, 2023

Primary Completion

June 25, 2024

Study Completion

June 27, 2024

Last Updated

June 6, 2024

Record last verified: 2024-06

Locations