NCT06671288

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

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

August 15, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 20, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

November 4, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

September 20, 2024

Last Update Submit

November 1, 2024

Conditions

Keywords

dysneaCigarette smokingspirometryQuality of life

Outcome Measures

Primary Outcomes (7)

  • FVC (forced vital capacity):

    FVC (forced vital capacity): The amount of air that can be maximum forcefully be exhaled after taking deep breath.

    4 weeks

  • FEV1

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

    4 weeks

  • FEV1/FVC

    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)

    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

    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

    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

    Pulse oximeter will be used to measure oxygen saturation

    4 weeks

Study Arms (2)

Interventional group

EXPERIMENTAL

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.

Control group

ACTIVE COMPARATOR

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

Interventions

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

Interventional group

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

Control group

Eligibility Criteria

Age25 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

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

SmokingCigarette Smoking

Condition Hierarchy (Ancestors)

BehaviorTobacco SmokingTobacco Use

Central Study Contacts

Tooba Shahbaz, MS-CPT*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized controlled trial having two groups. One group will receive (interventional group) balloon-blowing exercises with abdominal \& lumbar core muscles activation position. and the other group (control group) will receive Diaphragmatic breathing exercise.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2024

First Posted

November 4, 2024

Study Start

August 15, 2024

Primary Completion

January 1, 2025

Study Completion

February 1, 2025

Last Updated

November 4, 2024

Record last verified: 2024-08

Locations