NCT06032793

Brief Summary

Effects of deep breathing exercise on pulmonary function, perceived stress and physical fitness among healthy smokers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

September 5, 2023

Last Update Submit

January 10, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Forced Vital Capacity

    The volume of air which can be forcefully expelled from the lungs after taking a deep breath is known as forced vital capacity (FVC). The normal range of FVC for an adult lies between 3.0 and 5.0 L (29). The participant will be asked to seal their lips tightly over the mouthpiece and inhale as deeply as possible. Then they will exhale as forcefully as they can.

    baseline, on 2nd ,4th and 6th week

  • Forced Expiratory Volume

    FEV1 assesses how much air an individual can forcefully exhale. The forced expiratory volume in 1 second (FEV1) is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration. The forced expiratory volume (FEV) can be calculated for the first, second, and/or third seconds of the forced breath. With reference to GOLD range of COPD, the normal value for FEV is \<80. An FEV1 of less than 1 L indicates significant lung disease. For correct measures, the procedure will be repeated 3 times, and then the best value will be taken. The FEV1 is the measurement of dynamic volume most often used in conjunction with the FVC in analysis of spirometry.

    baseline, on 2nd ,4th and 6th week

  • PERCEIVED STRESS

    A more precise measure of personal stress can be determined by using a variety of instruments that have been designed to help measure individual stress levels. The first of these is called the Perceived Stress Scale. The Perceived Stress Scale (PSS) is a classic stress assessment instrument. It was originally developed in 1983.

    baseline, on 2nd ,4th and 6th week

  • Physical Fitness

    The six minute walking test (6MWT) will be used to determine the physical fitness. Each patient will be administered a 6-minute walk test. Two cones will be placed 100 feet apart in a hallway. Patients will instructed to walk as many laps around the cones as possible. A calibrated electronic pedometer (Omron Health Care Corporation, Vernon Hills, IL) will be worn on the hip of each patient to obtain the total number of steps taken during the test. Researcher will stand at the center of the 100-foot course and will encourage the patient after every 2 minutes. The researcher will record the time and distance to onset of exhaustion as well as the total distance walked and the total number of steps taken during the test. The walking distances will be subsequently converted from feet to meters.

    baseline, 2nd, 4th and on 6th week

Secondary Outcomes (1)

  • Sleep quality

    baseline, 2nd, 4th and on 6th week

Study Arms (2)

Deep breathing exercise

EXPERIMENTAL

This group will perform following exercises: Pursed lip breathing, Diaphragmatic breathing and powered breathing for 3-4 times a day for 6 weeks.

Other: Breathing exercises

No Intervention

NO INTERVENTION

This group will not perform any exercise.

Interventions

Pursed lip breathing, Diaphragmatic breathing and powered breathing

Deep breathing exercise

Eligibility Criteria

Age20 Years - 30 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly male participants
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Only Male Healthy Smoker.
  • Age: 20 - 30 years.
  • Participants had a minimum smoking history of 5 years.
  • Subject without any chronic pulmonary complication.

You may not qualify if:

  • Smokers with any pulmonary disease, acute infections, other systemic disease.
  • Chest deformity or any disability.
  • History of any surgery.
  • Not willing to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Railway General Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco Use

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Malik Muhammad Ali Awan, MSPT

    Riphah International University, Islamabad

    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

September 5, 2023

First Posted

September 13, 2023

Study Start

September 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

January 13, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations