Clinical trial NCT06869655: Resistive Diaphragmatic Training vs Volumes-Oriented Spirometer In Asthmatic Parients
Official title: Resistive Diaphragmatic Training Versus Volumes Oriented Spirometry On Pulmonary Function Test And Functional Capacity In Asthmatic Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Diaphragm training
Pulmonary function test
Rehabilitation
Spirometry
Six-minute walk test
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 6-MWT
timeFrame: 6-weeks
measure: Asthma Control Test
timeFrame: 6-weeks
measure: spirometer
timeFrame: 6-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Gulab Devi Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Qurat Ul Ain
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Mosnaim G. Asthma in Adults. N Engl J Med. 2023 Sep 14;389(11):1023-1031. doi: 10.1056/NEJMcp2304871. No abstract available.
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citation: 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.