"Effects of Balloon-blowing Exercises With Abdominal & Lumbar Core Muscle Activation Position Among Smokers"

November 1, 2024 updated by: Foundation University Islamabad

The principle function of the lungs is the facilitation of the gaseous exchange, commonly referred as respiratory or breathing. Cigarette smoking has detrimental effects on nearly every organ in the body, leading to a higher incidence of diseases and contributing to a gradual deterioration of the smoker's health.Cigarette smoking has detrimental effects on nearly every organ in the body, leading to a higher incidence of diseases and contributing to a gradual deterioration of the smoker's health.

Cigarette smoking is linked to mild airway obstruction and a deceleration in the growth of lung function.Performing balloon-blowing exercises with abdominal and lumbar core muscles activation position leads to an improvement on pulmonary function and quality of life in smokers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cigarette smoking has detrimental effects on nearly every organ in the body, leading to a higher incidence of diseases and contributing to a gradual deterioration of the smoker's health, including a progressive impairment of lung function. Cigarette smoking is linked to mild airway obstruction and a deceleration in the growth of lung function.

Smokers may experience inflammation and narrowing of their airways, resulting in increased resistance to the outward flow of air during exhalation. This restriction in airflow can negatively impact respiratory parameters, exercise tolerance, and overall quality of life.

Performing balloon-blowing exercises with abdominal and lumbar core muscles activation position leads to an improvement on pulmonary function and quality of life in smokers.

Study Type

Interventional

Enrollment (Estimated)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Recruiting
        • Foundation University College of Physical Therapy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults: aged (25-59 years)
  • Gender: Both males and females
  • Grade1- Grade 4 on Modified MRC dyspnea scale
  • COPD classes (mild, moderate ) according to GOLD COPD Guidelines
  • Participating voluntarily and follow the instructions & performing

  • The number of packs of cigarettes smoked per day by the number of years the person has smoked.

    1. pack yr = 20 cig/day x 1 yrs
    2. pack yr = 20 cig/day x 2 yrs

Exclusion criteria:

  • Severe cases of obstruction like Severe asthma & status asthmaticus, Severe COPD, bullous emphysema for pneumothorax.
  • Any congenital deformities of chest wall, Demonstrated neuromuscular or neurological deficit/disease of chest wall
  • Other serious Cardiopulmonary diseases including pulmonary embolism, pulmonary ----Hypertension, Active TB, pneumonias or other acute illnesses
  • Any recent cardiothoracic or abdominal surgery, trauma or injury
  • Pregnancy
  • Any psychiatric illnesses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional group
Patients in this group will receive balloon -blowing exercise with abdominal & lumbar core muscle activation position Total 4 weeks protocol. Three sessions per week will be supervised by physical therapist.
Other: Balloon-blowing exercises with abdominal & lumbar core muscle activation position.

Patients in this group will recieve Balloon-blowing exercises with abdominal and lumbar core muscles activation position Total 4 weeks protocol will be followed in which 3 sessions per week will be supervised by physical therapist.

FREQUENCY: 3 times a week, INTENSITY : Moderate, TIME: 4 sets of balloon-blowing with 1 min rest (30 mins) TYPE: Balloon-blowing with abdominal & lumbar core muscle activation position, DURATION : 4 weeks
Active Comparator: Control group

Patients will receive diaphragmatic breathing exercises. Total 4 weeks protocol.

Before and after 4 weeks pre and post interventional values will be taken.
Other: Diaphragmatic breathing exercise
Participants in this group will only be receiving diaphragmatic breathing exercise for 4 weeks. FREQUENCY: 3 times a week , INTENSITY: Moderate, TIME: 4 sets of diaphragmatic breathing with 1 min rest, TYPE: Diaphragmatic breathing, DURATION: 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FVC (forced vital capacity):
Time Frame: 4 weeks
FVC (forced vital capacity): The amount of air that can be maximum forcefully be exhaled after taking deep breath.
4 weeks
FEV1
Time Frame: 4 weeks
FEV1(Forced expiratory volume in 1 second): The volume of air that is forcefully exhaled in one second.
4 weeks
FEV1/FVC
Time Frame: 4 weeks
FEV1/FVC: The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs.
4 weeks
PEF (Peak expiratory flow)
Time Frame: 4 Weeks
PEF( Peak expiratory flow): Measurement of the highest speed at which a individual can exhale air from their lungs after a full inhalation.
4 Weeks
Dyspnea
Time Frame: 4 Weeks

Evaluation will be done using mMRC dyspnea scale (0-4). 0 I only get breathless with strenuous exercise

  1. I get short of breath when hurrying on level ground or walking up a slight hill
  2. On level ground, I walk slower than people of the same age because of breathlessness, or have to stop for breath when walking at my own pace
  3. I stop for breath after walking about 100 yards [91 meters] or after a few minutes on level ground
  4. I am too breathless to leave the house or I am breathless when dressing
4 Weeks
Quality of life of participant
Time Frame: 4 weeks

Quality of life questionnaire (SF-36) will be used to evaluate smokers QOLSF-36 Questionnaire (0-100). Each question carries equal weight the lower the score the more the disability. The higher the score the lesser the disability.

0: Maximum disability 100: No disability
4 weeks
Oxygen saturation
Time Frame: 4 weeks
Pulse oximeter will be used to measure oxygen saturation
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation University Islamabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

November 1, 2024

First Posted (Estimated)

November 4, 2024

Study Record Updates

Last Update Posted (Estimated)

November 4, 2024

Last Update Submitted That Met QC Criteria

November 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FUI/CTR/2024/27

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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