NCT06869655

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 20, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

Same day

First QC Date

February 20, 2025

Last Update Submit

March 10, 2025

Conditions

Asthma

Keywords

Diaphragm trainingPulmonary function testRehabilitationSpirometrySix-minute walk test

Outcome Measures

Primary Outcomes (3)

  • 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.

    6-weeks

  • 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.

    6-weeks

  • 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).

    6-weeks

Study Arms (2)

Threshold Loading device

EXPERIMENTAL

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

Volumes Oriented Spirometry

EXPERIMENTAL

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

Threshold Loading deviceDEVICE

threshold loading device for diaphragmatic resistance training

Threshold Loading device
Volumes Oriented SpirometryDEVICE

group B will receive this interentions

Volumes Oriented Spirometry

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulab Devi Hospital

Lahore, Punjab Province, 00, Pakistan

Location

Related Publications (5)

  • 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.

    PMID: 36873818BACKGROUND

  • 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.

    PMID: 36270294BACKGROUND

  • Mosnaim G. Asthma in Adults. N Engl J Med. 2023 Sep 14;389(11):1023-1031. doi: 10.1056/NEJMcp2304871. No abstract available.

    PMID: 37703556BACKGROUND

  • 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.

    PMID: 25973197BACKGROUND

  • 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.

    PMID: 33809922BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Qurat Ul Ain

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2025

First Posted

March 11, 2025

Study Start

March 10, 2024

Primary Completion

March 10, 2024

Study Completion

January 10, 2025

Last Updated

March 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)