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NCT Number: NCT06671288

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

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.

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Key information

Age range

25 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

Location status: Recruiting

Location contact

Sana Bashir, PhD*

CONTACT

[email protected]

0321-8529475

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Balloon-blowing exercises with abdominal & lumbar core muscle activation position.

Other

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

Diaphragmatic breathing exercise

Other

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

Primary outcomes

  1. 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.

  2. FEV1

    Time frame: 4 weeks

    FEV1(Forced expiratory volume in 1 second): The volume of air that is forcefully exhaled in one second.

  3. 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. 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.

  5. Dyspnea

    Time frame: 4 Weeks

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

    • I get short of breath when hurrying on level ground or walking up a slight hill
    • 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
    • I stop for breath after walking about 100 yards [91 meters] or after a few minutes on level ground
    • I am too breathless to leave the house or I am breathless when dressing
  6. 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

  7. Oxygen saturation

    Time frame: 4 weeks

    Pulse oximeter will be used to measure oxygen saturation

Study contacts

Contact information is provided by the study sponsor or research team.

Tooba Shahbaz, MS-CPT*

CONTACT

[email protected]

0340-5416747

Sponsors and collaborators

Lead sponsor

Foundation University Islamabad

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 4, 2024
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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