AsthmaNCT06762236
Combined Effects of Inspiratory Muscles Training With Pilate Training in Asthma Patients
A study testing Pillatate Training in people with Asthma, run by Riphah International University at 1 site in Pakistan.
Trial summary
Asthma is a chronic (long-term) condition that affects the airways in the lungs. The airways are tubes that carry air in and out of your lungs. In asthma the airways can become inflamed and narrowed at times. This makes it harder for air to flow out of your airways when you breathe out. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Pillatate Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Apr 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range from 30 to 50 (15)
- Both Male and Female
- FEV1 value range from 64% to less than 50%
- Medically cleared for cardiac rehabilitation.
- Medical treatment, for at least 6 months
- Clinically stable (i.e., no exacerbation or medication changes for at least 30 days.
Who cannot join
- Status Asthmatics
- Patient with cardiac disease
- Age range from 30 to 50 (15)
- Both Male and Female
- FEV1 value range from 64% to less than 50%
- Medically cleared for cardiac rehabilitation.
- Medical treatment, for at least 6 months
- Clinically stable (i.e., no exacerbation or medication changes for at least 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Effects of Inspiratory Muscles Training With Pilate Training on Dyspnea Cardiorespiratory Fitness Quality of Life in Asthma Patients
Asthma is a chronic (long-term) condition that affects the airways in the lungs. The airways are tubes that carry air in and out of your lungs. In asthma the airways can become inflamed and narrowed at times. This makes it harder for air to flow out of your airways when you breathe out. When symptoms get worse, it is called an asthma attack. There is no permeant cure for asthma, but medical treatment and physiotherapy treatment can help to manage it. There is many physiotherapy protocols can be used for asthma patients like aerobic exercises, breathing exercise etc. The objective of our study is determine the combine effects of inspiratory muscle training with Pilate training on dyspnea, cardiorespiratory fitness and quality of life in asthma patients.
The randomized control trial will used as study design as study design for this this purpose simple random sampling technique will be used to allocate the sample in two group The sample size will be calculated by the G-power analysis. This study will conduct in Jinnah Hospital, Lahore Group A will receive both inspiratory training and Pilate training and group B receive only Inspiratory training, incentive spirometer the participants were instructed to hold the breath for 2-3 seconds then exhale slowly. This process was repeated 10 times or about 10-15minutes with rest in between 30 seconds. Base line treatment is diaphragmatic breathing exercise .The session will repeated three times per week for 6 weeks with 40-minute sessions In Pilates we include 5 Pilate exercise, The Hundred (Rhythmic Breathing), Single Leg Stretch (Rhythmic Breathing), side kick, Toe Taps (Set Breathing Pattern) ,leg pull front. Pre and post measurement will be done using Juniper asthma quality of life, 6 mint walk test, Borges dyspnea scale and fatigue severity scale to measure the outcomes. Data will be analyzed SPSS version 25. T-test and Regression analysis will be used.
Key words: asthma patient, cardiorespiratory fitness, dyspnea, quality of life, Pilate training, inspiratory muscle training
Read the detailed description
To determine the combined effects of inspiratory muscles training with Pilate training on dyspnea, cardiorespiratory fitness quality of life in asthma patients
- Conditions
- Asthma
- Being tested
- Pillatate Training
- Keywords
- asthma patient, cardiorespiratory fitness, dyspnea, quality of life, Pilate training, inspiratory muscle training
- Medical subject headings
- Asthma, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pillatate TrainingOther
.The session will repeated three times per week for 6 weeks with 40-minute sessions In Pilates we include 5 Pilate exercise, The Hundred (Rhythmic Breathing), Single Leg Stretch (Rhythmic Breathing), side kick, Toe Taps (Set Breathing Pattern) ,leg pull front for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | .The session will repeated three times per week for 6 weeks with 40-minute sessions In Pilates we include 5 Pilate exercise, The Hundred (Rhythmic Breathing), Single Leg Stretch (Rhythmic Breathing), side kick, Toe Taps (Set Breathing Pattern) ,leg pull front for 6 weeks. Receives: Other: Pillatate Training |
| Controlied Group | Placebo comparator | Inspiratory training, incentive spirometer the participants were instructed to hold the breath for 2-3 seconds then exhale slowly. This process was repeated 10 times or about 10-15minutes with rest in between 30 seconds. Base line treatment is diaphragmatic breathing exercise Receives: Other: Pillatate Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF 36
A disease-specific health-related quality of life instrument developed by E. Juniper in1999and colleagues that taps both physical and emotional impact of disease. The instrument should not be confused with the measure developed by Marks and colleagues, which carries the same name. Asthma Quality of Life Questionnaire (AQLQ or AQLQ-J) developed by Juniper and colleagues is a 32 questions instrument to measure the functional problems that are most troublesome to adults. Symptoms (11 items), Activity Limitation (12 items, 5 of which are individualized), Emotional Function (5 items), and Environmental Exposure (4 items) Scaling of items 7-point Likert scale Scoring All items are weighted equally. Mean score is calculated across all items within each domain. Overall score is the mean across all items
Measured: 8 weeks
6MWT
The 6MWT is a sub-maximal exercise test used to examine person aerobic capacity and endurance. This test initially developed to make an assessment of patient with cardiopulmonary issues. It is used to check the functional capacity of the individual and it provides useful information regarding all the body systems during physical activity, including cardiovascular and pulmonary system. It can used for all age group range 2 to above 64 years The test is easy to perfume , with standardized limited instructions and encouragement being given as person walk as far as possible over 6 minutes through a flat corridor. The final distance is recorded in meters6
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start20 Apr 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumera Hameed, Mphill, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762236
- Sponsor's protocol ID
- Dureshawar Alamgir
- Status last verified
- Jan 2025
- First submitted
- 1 Jan 2025
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Inspiratory Muscles Training With Pilate Training on Dyspnea Cardiorespiratory Fitness Quality of Life in Asthma Patients
- ClinicalTrials.gov ID
- NCT06762236
- Acronym / sponsor ID
- Dureshawar Alamgir
- Conditions
- Asthma
- Keywords
- asthma patient, cardiorespiratory fitness, dyspnea, quality of life, Pilate training, inspiratory muscle training
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 7 Jan 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 is a chronic (long-term) condition that affects the airways in the lungs. The airways are tubes that carry air in and out of your lungs. In asthma the airways can become inflamed and narrowed at times. This makes it harder for air to flow out of your airways when you breathe out. When symptoms get worse, it is called an asthma attack. There is no permeant cure for asthma, but medical treatment and physiotherapy treatment can help to manage it. There is many physiotherapy protocols can be used for asthma patients like aerobic exercises, breathing exercise etc. The objective of our study is determine the combine effects of inspiratory muscle training with Pilate training on dyspnea, cardiorespiratory fitness and quality of life in asthma patients.
The randomized control trial will used as study design as study design for this this purpose simple random sampling technique will be used to allocate the sample in two group The sample size will be calculated by the G-power analysis. This study will conduct in Jinnah Hospital, Lahore Group A will receive both inspiratory training and Pilate training and group B receive only Inspiratory training, incentive spirometer the participants were instructed to hold the breath for 2-3 seconds then exhale slowly. This process was repeated 10 times or about 10-15minutes with rest in between 30 seconds. Base line treatment is diaphragmatic breathing exercise .The session will repeated three times per week for 6 weeks with 40-minute sessions In Pilates we include 5 Pilate exercise, The Hundred (Rhythmic Breathing), Single Leg Stretch (Rhythmic Breathing), side kick, Toe Taps (Set Breathing Pattern) ,leg pull front. Pre and post measurement will be done using Juniper asthma quality of life, 6 mint walk test, Borges dyspnea scale and fatigue severity scale to measure the outcomes. Data will be analyzed SPSS version 25. T-test and Regression analysis will be used.
Key words: asthma patient, cardiorespiratory fitness, dyspnea, quality of life, Pilate training, inspiratory muscle training
Detailed description
To determine the combined effects of inspiratory muscles training with Pilate training on dyspnea, cardiorespiratory fitness quality of life in asthma patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Pillatate Training.The session will repeated three times per week for 6 weeks with 40-minute sessions In Pilates we include 5 Pilate exercise, The Hundred (Rhythmic Breathing), Single Leg Stretch (Rhythmic Breathing), side kick, Toe Taps (Set Breathing Pattern) ,leg pull front for 6 weeks. |
| Controlied Group | Placebo comparator | Other: Pillatate TrainingInspiratory training, incentive spirometer the participants were instructed to hold the breath for 2-3 seconds then exhale slowly. This process was repeated 10 times or about 10-15minutes with rest in between 30 seconds. Base line treatment is diaphragmatic breathing exercise |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age range from 30 to 50 (15)
- Both Male and Female
- FEV1 value range from 64% to less than 50%
- Medically cleared for cardiac rehabilitation.
- Medical treatment, for at least 6 months
Key exclusion criteria (8 listed)
- Status Asthmatics
- Patient with cardiac disease
- Age range from 30 to 50 (15)
- Both Male and Female
- FEV1 value range from 64% to less than 50%
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 |
|---|---|---|
| Pillatate Training.The session will repeated three times per week for 6 weeks with 40-minute sessions In Pilates we include 5 Pilate exercise, The Hundred (Rhythmic Breathing), Single Leg Stretch (Rhythmic Breathing), side kick, Toe Taps (Set Breathing Pattern) ,leg pull front for 6 weeks. | Other | Controlied Group, Treatment Group |
Primary outcome
SF 36
Time frame: 8 weeks
A disease-specific health-related quality of life instrument developed by E. Juniper in1999and colleagues that taps both physical and emotional impact of disease. The instrument should not be confused with the measure developed by Marks and colleagues, which carries the same name. Asthma Quality of Life Questionnaire (AQLQ or AQLQ-J) developed by Juniper and colleagues is a 32 questions instrument to measure the functional problems that are most troublesome to adults. Symptoms (11 items), Activity Limitation (12 items, 5 of which are individualized), Emotional Function (5 items), and Environmental Exposure (4 items) Scaling of items 7-point Likert scale Scoring All items are weighted equally. Mean score is calculated across all items within each domain. Overall score is the mean across all items
6MWT
Time frame: 8 weeks
The 6MWT is a sub-maximal exercise test used to examine person aerobic capacity and endurance. This test initially developed to make an assessment of patient with cardiopulmonary issues. It is used to check the functional capacity of the individual and it provides useful information regarding all the body systems during physical activity, including cardiovascular and pulmonary system. It can used for all age group range 2 to above 64 years The test is easy to perfume , with standardized limited instructions and encouragement being given as person walk as far as possible over 6 minutes through a flat corridor. The final distance is recorded in meters6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- 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.
Sumera Hameed, Mphill 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 Pillatate Training 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 6 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 7 Jan 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
SF 36 (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2025.