Effects of Balloon-blowing Exercises in 90/90 Bridge Position With a Ball on Pulmonary Function Among Asthmatic Patients

October 24, 2024 updated by: Foundation University Islamabad
In asthma, the airways in the respiratory system can experience inflammation and constriction, causing increased difficulty in expelling air during exhalation. This results in disruptions to respiratory parameters, exercise intolerance, and a diminished overall quality of life.Engaging in balloon-blowing exercises while in a 90/90 bridge position with the use of a ball will lead to enhanced pulmonary function and quality of life in individuals with asthma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Asthma attacks and labored breathing can cause strain and weakness in the diaphragm, the main muscle supporting breathing, as well as the muscles of core.

The study objective is to determine the effects of balloon-blowing exercises in 90/90 bridge posotion with a ball on pulmonary function and quality of life among asthmatic patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults: aged (18-59 years)
  • Gender: Both male and females
  • Grade1- Grade 4 on Modified MRC dyspnea scale
  • Asthma severity ( level 1 mild intermediate, levell 2 mild persistent)

Exclusion criteria:

  • Level 3 and above asthmatics or status asthmatics.
  • Any congenital deformities of chest wall/ Heart/ Lungs.
  • Demonstrated neuromuscular or neurological deficit/ chest wall deformity.
  • Cardiopulmonary diseases including coronary artery disease(CAD), Pulmonary HTN, ------Aortic Stenosis, regurgitation, etc.
  • Any Autoimmune disease with manifestations of Chest wall/ heart/ Lungs.
  • Any recent cardiothoracic or abdominal surgery or sternotomy.
  • Recent history of the blunt chest wall or abdominal trauma.
  • Unstable hemodynamic parameters (arterial pressure >140mmhg systolic and >90mmhg for diastolic).
  • Pregnancy

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Interventional group
In this group patients will undergo balloon-blowing exercises in the 90/90 bridge position with a ball. In this intervention, patients lie on back with feet against a wall and knee bent at 90 degrees, holding a ball between their knees. While extending one arm overhead and holding a balloon in the other hand, perform a pelvic tilt without lifting their backoff the mat. Inhale through the nose, exhale into the balloon for four breaths, then remove the balloon and repeat the sequence four times. The 4-week protocol includes three supervised sessions per week, each supervised by a physiotherapist. Progress will be monitored regularly to evaluate improvements throughout the intervention.
Procedure: Balloon-blowing exercises in 90/90 bridge position with a ball.
In this group patients will undergo balloon-blowing exercises in the 90/90 bridge position with a ball. In this intervention, patients lie on back with feet against a wall and knee bent at 90 degrees, holding a ball between their knees. While extending one arm overhead and holding a balloon in the other hand, perform a pelvic tilt without lifting their back off the mat. Inhale through the nose, exhale into the balloon for four breaths, then remove the balloon and repeat the sequence four times. The 4-week protocol includes three supervised sessions per week, each supervised by a physiotherapist. Progress will be monitored regularly to evaluate improvements throughout the intervention.
Experimental: Control group
In this group, patient will receive Buteyko breathing exercises consists of two main exercises; the control pause and the maximum pause .For control pause, patient exhale, plug the nose, and hold their breath until they feel the urge to breathe, then inhale and breathe normally for 10 seconds.In Maximum pause, patient exhale,plug their nose ,and hold their breath as long as posiible, aiming for double the control pause time, then inhale and breath normally for 10 seconds.This is a 4-week protocol with three sessions per week.Pre- and post- intervention values will be recorded to assess progress.n.
Procedure: Buteyko breathing exercises management
In this group, patients will receive Buteyko breathing exercises, which consist of two main exercises; the control pause and the maximum pause. For control pause, patients exhale, plug the nose, and hold their breath until they feel the urge to breathe, then inhale and breathe normally for 10 seconds. In Maximum pause, patients exhale, plug their nose, and hold their breath as long as possible, aiming for double the control pause time, then inhale and breath normally for 10 seconds. This is a 4-week protocol with three sessions per week. Pre- and post-intervention values will be recorded to assess progress.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pulmonary function test
Time Frame: 4 weeks
Evaluation will be done using Spirometry
4 weeks
Dyspnea
Time Frame: 4 weeks
Evaluation will be done using mMRC scale
4 weeks
Quality of life of patient
Time Frame: 4 Weeks
Quality of life will be evaluated by asthma quality of life questionnaire with standardized Activities AQLQ(S)
4 Weeks
Oxygen Saturation
Time Frame: 4 Weeks
Oxygen saturation will be evaluated by pulse oximeter
4 Weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FUI/CTR/2024/37

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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