NCT03728530

Brief Summary

To determine the effect of deep breathing exercises on lung function in healthy smokers.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Status
completed

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

October 3, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2017

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2018

Completed
10 months until next milestone

First Posted

Study publicly available on registry

November 2, 2018

Completed
Last Updated

November 2, 2018

Status Verified

November 1, 2018

Enrollment Period

5 months

First QC Date

January 11, 2018

Last Update Submit

November 1, 2018

Conditions

Keywords

Deep breathing exercises, smokers, lung function

Outcome Measures

Primary Outcomes (3)

  • Oxygen Saturation

    Pulse Oximetry was used to measure oxygen saturation

    2 weeks

  • Lung Volumes

    All lung volume were measured with spirometer

    2 weeks

  • Lung Capacities

    All lung capacities were measured with spirometer

    2 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Deep /breathing exercises including Purse lip, diaphragmatic breathing and powered breathing

Other: Deep Breathing exercises

Control Group

NO INTERVENTION

The participants from control group did not perform any exercise.

Interventions

In pursed lip exercise subject was guided to inhale through nose with mouth closed and exhale through pressed lips (pursed lips). In Diaphragmatic breathing subject was instructed to place his one hand below the rib cage and the other hand on chest. The patient inhaled slowly so that stomach moves out against the hand. Tighten the stomach muscle while exhaling through pursed lip. In powered breathing subject was to inhale and exhale forcefully with some movements like subject was instructed to inhale forcefully while moving his hands upward and exhale forcefully while moving hands downward. These three exercise techniques were advised to each subject of experimental group. They have to practice these exercises 3-4 times a day with 10 repetitions each. These exercises can be performed in sitting position or in supine lying position. Subject can adopt any position in which he feels comfortable.

Experimental Group

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Young male and female adults with age group of 20-30 years without any chronic complication doing smoking from past five years are included in this study as the basic purpose of the study is to determine the effects of deep breathing exercises in smokers

You may not qualify if:

  • Adults with pulmonary disease.
  • Acute infections
  • Any other systemic disease.
  • Chest deformity.
  • Adults with any disability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Study was to determine the effects of deep breathing exercises in smokers. It was conducted on the general population of Isra Institute of Rehabilitation Sciences, Isra University, Islamabad Campus. 30 participants were selected through Non probability Convenience Sampling and later equally divided into experimental (n=15) and control group (n=15) through lottery method. Inclusion criteria were young smokers between 20-30 years of age and without any chronic pulmonary complication, smoking for past five years. Smokers with any pulmonary disease, acute infections, other systemic disease, chest deformity or any disability were excluded from study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

January 11, 2018

First Posted

November 2, 2018

Study Start

October 3, 2016

Primary Completion

February 22, 2017

Study Completion

March 15, 2017

Last Updated

November 2, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data will become available within a month