NCT06660537

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
41

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable asthma

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
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 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

October 28, 2024

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

October 24, 2024

Last Update Submit

October 24, 2024

Conditions

Keywords

Dyspnea, asthma, spirometry, quality of life, oxygen saturation

Outcome Measures

Primary Outcomes (4)

  • pulmonary function test

    Evaluation will be done using Spirometry

    4 weeks

  • Dyspnea

    Evaluation will be done using mMRC scale

    4 weeks

  • Quality of life of patient

    Quality of life will be evaluated by asthma quality of life questionnaire with standardized Activities AQLQ(S)

    4 Weeks

  • Oxygen Saturation

    Oxygen saturation will be evaluated by pulse oximeter

    4 Weeks

Study Arms (2)

Interventional group

EXPERIMENTAL

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.

Control group

EXPERIMENTAL

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

Interventions

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.

Interventional group

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.

Control group

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

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

AsthmaDyspnea

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Anam Anwar, 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 in 90/90 bridge position with a ball and the other group (control group) will receive buteyko breathing exercises.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2024

First Posted

October 28, 2024

Study Start

August 15, 2024

Primary Completion

January 1, 2025

Study Completion

February 1, 2025

Last Updated

October 28, 2024

Record last verified: 2024-09

Locations