AsthmaNCT06869655
Resistive Diaphragmatic Training vs Volumes-Oriented Spirometer In Asthmatic Parients
A study testing Threshold Loading device and Volumes Oriented Spirometry in people with Asthma, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- Threshold Loading device and Volumes Oriented Spirometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Mar 2024to 10 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Asthma
- Being tested
- Threshold Loading device, Volumes Oriented Spirometry
- Keywords
- Diaphragm training, Pulmonary function test, Rehabilitation, Spirometry, Six-minute walk test
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threshold Loading deviceDevice
threshold loading device for diaphragmatic resistance training
Volumes Oriented SpirometryDevice
group B will receive this interentions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Volumes Oriented Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start10 Mar 2024
- Primary completion10 Mar 2024
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qurat Ul Ain, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869655
- Sponsor's protocol ID
- REC/RCR & AHS/24/0321 Maria
- Status last verified
- Mar 2025
- First submitted
- 20 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 36873818Aegerter 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 36270294Mosnaim G. Asthma in Adults. N Engl J Med. 2023 Sep 14;389(11):1023-1031. doi: 10.1056/NEJMcp2304871. No abstract available.
PubMed 37703556Ramos 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 25973197Chung 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistive Diaphragmatic Training Versus Volumes Oriented Spirometry On Pulmonary Function Test And Functional Capacity In Asthmatic Patients.
- ClinicalTrials.gov ID
- NCT06869655
- Acronym / sponsor ID
- REC/RCR & AHS/24/0321 Maria
- Conditions
- Asthma
- Keywords
- Diaphragm training, Pulmonary function test, Rehabilitation, Spirometry, Six-minute walk test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Threshold Loading device | Experimental | Device: Threshold Loading deviceResistive 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. |
| Volumes Oriented Spirometry | Experimental | Device: Volumes Oriented Spirometryvolume-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. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Threshold Loading devicethreshold loading device for diaphragmatic resistance training | Device | Threshold Loading device |
| Volumes Oriented Spirometrygroup B will receive this interentions | Device | Volumes Oriented Spirometry |
Primary outcome
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.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Background: PubMed 36873818de 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.
- Background: PubMed 36270294Aegerter 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.
- Background: PubMed 37703556Mosnaim G. Asthma in Adults. N Engl J Med. 2023 Sep 14;389(11):1023-1031. doi: 10.1056/NEJMcp2304871. No abstract available.
- Background: PubMed 25973197Ramos 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.
- Background: PubMed 33809922Chung 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qurat Ul Ain principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Threshold Loading device and Volumes Oriented Spirometry in people with Asthma, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-MWT (time frame: 6-weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06869655, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.