Resistive Diaphragmatic Training vs Volumes-Oriented Spirometer In Asthmatic Parients

March 10, 2025 updated by: Riphah International University

Resistive Diaphragmatic Training Versus Volumes Oriented Spirometry On Pulmonary Function Test And Functional Capacity In Asthmatic Patients.

Asthma, a chronic lung disease characterized by airway inflammation and constriction, presents ongoing challenges despite advancements in treatment. The aim of this study to deliver non-pharmacological interventions, particularly comparing resistive diaphragmatic training (RDT) and volume-oriented spirometry, to assess their efficacy in enhancing pulmonary function and functional capacity among asthmatic patients. it will compare resistive diaphragmatic training (RDT) with volume-oriented spirometry in asthmatic patients to pinpoint the superior method for enhancing lung function and daily capabilities.

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

Asthma is a chronic lung disease characterized by airway inflammation and constriction, presents ongoing challenges despite advancements in treatment.The aim of this study is to deliver non-pharmacological interventions, comparing resistive diaphragmatic training (RDT) and volume-oriented spirometry, to assess their efficacy in enhancing pulmonary function and functional capacity among asthmatic patients. Method: This study will be conducted at "Gulab Devi Chest Hospital" Lahore, it is randomized clinical trial (RCT) which will divided into two groups: Group A include RDT along conventional physiotherapy treatment and Group B include volume-oriented spirometry along conventional physiotherapy treatment. Total 50 subjects will be recruited according inclusion and exclusions criteria by convenient sampling technique. Data collection procedure will follow standardized procedures like pre-assessment and post-assessment which will be after 6 weeks with spirometry, 6MWT, and the ACT. Hypothesis postulated that RDT will show greater mprovements in pulmonary function and functional capacity compared to volumes oriented spirometry. However, null hypothesis will suggest that there is no significant difference between the two interventions.

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.
50

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
      • Lahore, Punjab, Pakistan, 00
        • Gulab Devi hospital

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 range between 35 years to 50 years who must have a confirm diagnosis of asthma and FEV1% >60% & <80%, both male and female with moderate asthma. Outpatients from regional medical Centre.

Exclusion Criteria:

  • Asthma patients whose condition require hospitalization asthmatic patients with physical limitation patients, with exercise-induced asthma, Asthma patients with heart dis¬ease with evidence of cardiovascular osteoarticular, inability to consent or cooperate, long-term, home oxygen therapy, active tuberculosis or other infectious disorders as well as stroke, are excluded

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: Double

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: Threshold Loading device
Resistive Diaphragmatic Training: In this group of participants will receive resistive diaphragm training with the help of threshold loading device along conventional physiotherapy under supervision for 6 weeks.
Device: Threshold Loading device
threshold loading device for diaphragmatic resistance training
Experimental: Volumes Oriented Spirometry
volume-oriented incentive spirometry: In this group of participants will receive training through volume-oriented incentive spirometer emphasizing lung capacity and airflow along with conventional physiotherapy under supervision for 6 weeks.
Device: Volumes Oriented Spirometry
group B will receive this interentions

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
6-MWT
Time Frame: 6-weeks
For the 6MWT assessment, the participants were encouraged to walk as far as they could during 6 min over a flat 100-feet surface, and for consistency, the researchers used constant verbal cues and positive feedback to encourage the participants to complete the task. The 6-Minute Walk Test (6MWT) assesses aerobic capacity and functional exercise capacity by measuring the distance a person can walk in 6 minutes. Results are interpreted based on the distance walked, which correlates with functional capacity.
6-weeks
Asthma Control Test
Time Frame: 6-weeks
The ACT is a validated, patient-completed measure of asthma control that includes five questions that assess activity limitations, shortness of breath, nighttime symptoms, use of rescue medication, and patient overall rating of asthma control over the previous four weeks. The questions are scored from 1 (worst) to 5 (best), and the ACT score is the sum of the responses, giving a maximum best score of 25.
6-weeks
spirometer
Time Frame: 6-weeks
For Pulmonary Function, FEV1 will be used to assess lung function. A spirometer will be used to measure forced expiratory volume in 1 second (FEV1). The spirometer is a simple test and an essential tool in diagnosing airway obstruction. However, the variability of spirometry measurements is greater than in most other clinical laboratory tests because the result is highly dependent on the consistency of the efforts made by patients and technicians. Normal values vary based on age, sex, height, and ethnicity. Interpretations are based on comparing results to predicted values, aiding in diagnosing conditions like asthma or COPD. However, interpretation accuracy can also depend on the expertise of the interpreter and clinical context. For instance: FVC: Around 80-120% of predicted value, FEV1: Around 75-85% of predicted value and FEV1/FVC ratio: Typically >0.7 (adults).
6-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.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Qurat ul Ain, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
March 10, 2024

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.
March 10, 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.
January 10, 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).
February 20, 2025

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.
March 10, 2025

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.
March 25, 2025

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.
March 25, 2025

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.
March 10, 2025

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.
March 1, 2025

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.
  • REC/RCR & AHS/24/0321 Maria

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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