Effects of Core Stability Combined With Diaphragmatic Strengthening Exercises Among Asthmatic Patients

June 26, 2024 updated by: Foundation University Islamabad
This is a quasi intervention study evaluating the effects of core stabilization exercises and diaphragmatic strengthening on thoracic kyphosis angle, diaphragmatic excursion, chest expansion, lung functioning (FEV1/FVC ratio) and quality of life, in individuals with mild intermittent or mild persistent asthma.

Study Overview

Status

Status

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

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

This study evaluated the effects of core stabilization exercises and diaphragmatic strengthening on thoracic kyphosis angle, diaphragmatic excursion, chest expansion, lung functioning (FEV1/FVC ratio), and quality of life in individuals with mild intermittent or mild persistent asthma. Thirty-seven participants from Fauji Foundation Hospital Rawalpindi underwent assessments before and after an 18-session treatment regimen over three weeks. The measures included diaphragmatic excursion, thoracic kyphotic angle, chest expansion, spirometry, and asthma quality of life questionnaire. Statistical analysis was performed using SPSS version 21

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 (Actual)

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 Locations

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

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:

  • Age group: 18-34 years old
  • Both males and females
  • Individuals diagnosed with well controlled mild intermittent asthma or mild persistent asthma, at least six months prior based on referral from pulmonologist.
  • Individuals who have weak core muscles
  • Participating to the study in a voluntary basis

Exclusion Criteria:

  • Level 3 and above asthmatics or status asthmaticus
  • Any congenital deformities of chest wall
  • Demonstrated neuromuscular or neurological deficit/disease of chest wall.
  • Cardiopulmonary diseases including coronary artery disease, heart failure NYHA classification, valvular heart disease, cardiomyopathy, arrythmias, interstitial lung disease, COPD, pulmonary embolism, pulmonary hypertension, cancers, etc.
  • 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
  • Previous or parallel participation in interventional programs
  • 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: N/A
  • Interventional Model: Single Group 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: Core stabilization and Diaphragmatic Exercise Group
The intervention consisted of 18 sessions over three weeks, following the FITT protocol. Each session included a warm-up (5 minutes), core stability exercises (15 minutes), diaphragmatic strengthening exercises (10 minutes), and cool-down (5 minutes), with rest intervals. Exercises progressed in difficulty on stable surfaces, tailored to each participant's tolerance. Warm-up exercises included activities like hopping and knee circles, while core stability exercises featured moves such as planks and side planks. Diaphragmatic exercises included diaphragmatic breathing in various positions.
Procedure: Core stability exercise
Core stability exercises featured moves such as planks and side planks.
Procedure: Diaphragmatic Strengthening Exercise
. Diaphragmatic exercises included diaphragmatic breathing in various positions.

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
Thoracic Kyphosis Angle
Time Frame: 18 days
Measured with Inclinometer
18 days
Diaphragmatic Excursion
Time Frame: 18 days
Measured using Tape method
18 days
Chest Expansion
Time Frame: 18 days
Measured using Tape method
18 days
FEV1/FVC ratio
Time Frame: 18 days
Measured using Spirometer
18 days
Quality of Life of patient
Time Frame: 18 days
Asthma Quality of Life Questionnaire with Standardized Activities. It is a 32-item Likert-type scale that measures the impact of asthma on daily activities, with scores ranging from 1 (severe impairment) to 7 (no impairment).
18 days

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.
July 15, 2023

Primary Completion (Actual)

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.
April 18, 2024

Study Completion (Actual)

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.
May 24, 2024

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).
June 7, 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.
June 26, 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.
June 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.
June 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.
June 26, 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.
June 1, 2024

More Information

Terms related to this study

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/2024/14

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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