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CompletedNCT06869655Updated Mar 11, 2025

Resistive Diaphragmatic Training vs Volumes-Oriented Spirometer In Asthmatic Parients

An interventional study of Threshold Loading device and Volumes Oriented Spirometry in Asthma, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 35 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-03-11.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Mar 2024, registered Feb 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
35 Years to 50 Years
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Asthma

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Keywords

  • Diaphragm training
  • Pulmonary function test
  • Rehabilitation
  • Spirometry
  • Six-minute walk test
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In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 50 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceThreshold Loading device

    threshold loading device for diaphragmatic resistance training

  • DeviceVolumes Oriented Spirometry

    group B will receive this interentions

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What researchers measure

Primary outcomes

  1. 6-MWT

    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.

    Time frame: 6-weeks

  2. Asthma Control Test

    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.

    Time frame: 6-weeks

  3. spirometer

    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).

    Time frame: 6-weeks

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Study locations

1 site
  • Gulab Devi Hospital
    Lahore, Punjab 00, Pakistan
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References and documents

Publications

  • de Lima FF, Pinheiro DHA, de Carvalho CRF. Physical training in adults with asthma: An integrative approach on strategies, mechanisms, and benefits. Front Rehabil Sci. 2023 Feb 17;4:1115352. doi: 10.3389/fresc.2023.1115352. eCollection 2023. PubMed 36873818 ↗
  • Aegerter H, Lambrecht BN. The Pathology of Asthma: What Is Obstructing Our View? Annu Rev Pathol. 2023 Jan 24;18:387-409. doi: 10.1146/annurev-pathol-042220-015902. Epub 2022 Oct 21. PubMed 36270294 ↗
  • Mosnaim G. Asthma in Adults. N Engl J Med. 2023 Sep 14;389(11):1023-1031. doi: 10.1056/NEJMcp2304871. No abstract available. PubMed 37703556 ↗
  • Ramos E, de Oliveira LV, Silva AB, Costa IP, Correa JC, Costa D, Alves VL, Donner CF, Stirbulov R, Arena R, Sampaio LM. Peripheral muscle strength and functional capacity in patients with moderate to severe asthma. Multidiscip Respir Med. 2015 Jan 21;10(1):3. doi: 10.1186/2049-6958-10-3. eCollection 2015. PubMed 25973197 ↗
  • Chung Y, Huang TY, Liao YH, Kuo YC. 12-Week Inspiratory Muscle Training Improves Respiratory Muscle Strength in Adult Patients with Stable Asthma: A Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Mar 22;18(6):3267. doi: 10.3390/ijerph18063267. PubMed 33809922 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06869655
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Mar 11, 2025
Start date
Mar 10, 2024
Primary completion
Mar 10, 2024
Completion
Jan 10, 2025
Last update
Mar 11, 2025

Study contacts

Qurat Ul Ain
principal investigator · Riphah International University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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