Mild Intermittent AsthmaNCT06479902
Effects of Core Stability Combined With Diaphragmatic Strengthening Exercises Among Asthmatic Patients
A study testing Core stability exercise and Diaphragmatic Strengthening Exercise in people with Mild Intermittent Asthma, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
This is a quasi intervention study evaluating the effects of core stabilization exercises and diaphragmatic strengthening on thoracic kyphosis angle, diaphragmatic excursion, chest expansion, lung functioning (FEV1/FVC ratio) and quality of life, in individuals with mild intermittent or mild persistent asthma. Read more about this study
- Who is it for?
- Ages 18 to 34 years
- Conditions the study is for
- Mild Intermittent Asthma
- What is being tested?
- Core stability exercise and Diaphragmatic Strengthening Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2023to 24 May 2024
- 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 18 to 34 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group: 18-34 years old
- Both males and females
- Individuals diagnosed with well controlled mild intermittent asthma or mild persistent asthma, at least six months prior based on referral from pulmonologist.
- Individuals who have weak core muscles
- Participating to the study in a voluntary basis
Who cannot join
- Level 3 and above asthmatics or status asthmaticus
- Any congenital deformities of chest wall
- Demonstrated neuromuscular or neurological deficit/disease of chest wall.
- Cardiopulmonary diseases including coronary artery disease, heart failure NYHA classification, valvular heart disease, cardiomyopathy, arrythmias, interstitial lung disease, COPD, pulmonary embolism, pulmonary hypertension, cancers, etc.
- Any recent cardiothoracic or abdominal surgery or sternotomy
- Recent history of the blunt chest wall or abdominal trauma
Show all 10Show fewer
- Unstable hemodynamic parameters (arterial pressure >140mmhg systolic and >90mmhg for diastolic
- Pregnancy
- Previous or parallel participation in interventional programs
- Any psychiatric illnesses
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
About this study
This is a quasi intervention study evaluating the effects of core stabilization exercises and diaphragmatic strengthening on thoracic kyphosis angle, diaphragmatic excursion, chest expansion, lung functioning (FEV1/FVC ratio) and quality of life, in individuals with mild intermittent or mild persistent asthma.
Read the detailed description
This study evaluated the effects of core stabilization exercises and diaphragmatic strengthening on thoracic kyphosis angle, diaphragmatic excursion, chest expansion, lung functioning (FEV1/FVC ratio), and quality of life in individuals with mild intermittent or mild persistent asthma. Thirty-seven participants from Fauji Foundation Hospital Rawalpindi underwent assessments before and after an 18-session treatment regimen over three weeks. The measures included diaphragmatic excursion, thoracic kyphotic angle, chest expansion, spirometry, and asthma quality of life questionnaire. Statistical analysis was performed using SPSS version 21
- Conditions
- Mild Intermittent Asthma
- Being tested
- Core stability exercise, Diaphragmatic Strengthening Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stability exerciseProcedure or surgery
Core stability exercises featured moves such as planks and side planks.
Diaphragmatic Strengthening ExerciseProcedure or surgery
. Diaphragmatic exercises included diaphragmatic breathing in various positions.
| Study group | Role | What they receive |
|---|---|---|
| Core stabilization and Diaphragmatic Exercise Group | Experimental | The intervention consisted of 18 sessions over three weeks, following the FITT protocol. Each session included a warm-up (5 minutes), core stability exercises (15 minutes), diaphragmatic strengthening exercises (10 minutes), and cool-down (5 minutes), with rest intervals. Exercises progressed in difficulty on stable surfaces, tailored to each participant's tolerance. Warm-up exercises included activities like hopping and knee circles, while core stability exercises featured moves such as planks and side planks. Diaphragmatic exercises included diaphragmatic breathing in various positions. Receives: Procedure: Core stability exercise; Procedure: Diaphragmatic Strengthening Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoracic Kyphosis Angle
Measured with Inclinometer
Measured: 18 days
Diaphragmatic Excursion
Measured using Tape method
Measured: 18 days
Chest Expansion
Measured using Tape method
Measured: 18 days
FEV1/FVC ratio
Measured using Spirometer
Measured: 18 days
Quality of Life of patient
Asthma Quality of Life Questionnaire with Standardized Activities. It is a 32-item Likert-type scale that measures the impact of asthma on daily activities, with scores ranging from 1 (severe impairment) to 7 (no impairment).
Measured: 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start15 Jul 2023
- Primary completion18 Apr 2024
- Study completion24 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Intermittent AsthmaStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi Interventional Study
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479902
- Sponsor's protocol ID
- FUI/CTR/2024/14
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Core Stability Combined With Diaphragmatic Strengthening Exercises Among Asthmatic Patients
- ClinicalTrials.gov ID
- NCT06479902
- Acronym / sponsor ID
- FUI/CTR/2024/14
- Conditions
- Mild Intermittent Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 28 Jun 2024 (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.
This is a quasi intervention study evaluating the effects of core stabilization exercises and diaphragmatic strengthening on thoracic kyphosis angle, diaphragmatic excursion, chest expansion, lung functioning (FEV1/FVC ratio) and quality of life, in individuals with mild intermittent or mild persistent asthma.
Detailed description
This study evaluated the effects of core stabilization exercises and diaphragmatic strengthening on thoracic kyphosis angle, diaphragmatic excursion, chest expansion, lung functioning (FEV1/FVC ratio), and quality of life in individuals with mild intermittent or mild persistent asthma. Thirty-seven participants from Fauji Foundation Hospital Rawalpindi underwent assessments before and after an 18-session treatment regimen over three weeks. The measures included diaphragmatic excursion, thoracic kyphotic angle, chest expansion, spirometry, and asthma quality of life questionnaire. Statistical analysis was performed using SPSS version 21
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi Interventional Study
| Arm | Type | Receives |
|---|---|---|
| Core stabilization and Diaphragmatic Exercise Group | Experimental | Procedure: Core stability exercise, Procedure: Diaphragmatic Strengthening ExerciseThe intervention consisted of 18 sessions over three weeks, following the FITT protocol. Each session included a warm-up (5 minutes), core stability exercises (15 minutes), diaphragmatic strengthening exercises (10 minutes), and cool-down (5 minutes), with rest intervals. Exercises progressed in difficulty on stable surfaces, tailored to each participant's tolerance. Warm-up exercises included activities like hopping and knee circles, while core stability exercises featured moves such as planks and side planks. Diaphragmatic exercises included diaphragmatic breathing in various positions. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age group: 18-34 years old
- Both males and females
- Individuals diagnosed with well controlled mild intermittent asthma or mild persistent asthma, at least six months prior based on referral from pulmonologist.
- Individuals who have weak core muscles
- Participating to the study in a voluntary basis
Key exclusion criteria (10 listed)
- Level 3 and above asthmatics or status asthmaticus
- Any congenital deformities of chest wall
- Demonstrated neuromuscular or neurological deficit/disease of chest wall.
- Cardiopulmonary diseases including coronary artery disease, heart failure NYHA classification, valvular heart disease, cardiomyopathy, arrythmias, interstitial lung disease, COPD, pulmonary embolism, pulmonary hypertension, cancers, etc.
- Any recent cardiothoracic or abdominal surgery or sternotomy
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 |
|---|---|---|
| Core stability exerciseCore stability exercises featured moves such as planks and side planks. | Procedure or surgery | Core stabilization and Diaphragmatic Exercise Group |
| Diaphragmatic Strengthening Exercise. Diaphragmatic exercises included diaphragmatic breathing in various positions. | Procedure or surgery | Core stabilization and Diaphragmatic Exercise Group |
Primary outcome
Thoracic Kyphosis Angle
Time frame: 18 days
Measured with Inclinometer
Diaphragmatic Excursion
Time frame: 18 days
Measured using Tape method
Chest Expansion
Time frame: 18 days
Measured using Tape method
FEV1/FVC ratio
Time frame: 18 days
Measured using Spirometer
Quality of Life of patient
Time frame: 18 days
Asthma Quality of Life Questionnaire with Standardized Activities. It is a 32-item Likert-type scale that measures the impact of asthma on daily activities, with scores ranging from 1 (severe impairment) to 7 (no impairment).
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 28 Jun 2024.
Related trials for Mild Intermittent Asthma
Recruiting
Investigating the Impact of Early Time-Restricted Eating on Health Outcomes and Quality of Life in Adults With Mild Controlled Asthma Compared to Healthy Adults
Asthma Management, Time Restricted Eating
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core stability exercise and Diaphragmatic Strengthening Exercise in people with Mild Intermittent Asthma, run by Foundation University Islamabad 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 5 inclusion and 10 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 28 Jun 2024. 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?
Thoracic Kyphosis Angle (time frame: 18 days). The study lists 5 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 28 Jun 2024.