Stroke, IschemicNCT06326801
Resistive Diaphragmatic Breathing Exercise With Pursed Lips Breathing Exercise in Sub-acute Stroke Patients
A study testing Resistive Diaphragmatic breathing exercise, Diaphragmatic breathing exercise and Conventional stroke physiotherapy in people with Stroke, Ischemic, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve pulmonary function in sub-acute ischemic stroke, To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve Trunk Control in sub-acute ischemic stroke, To… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Resistive Diaphragmatic breathing exercise, Diaphragmatic breathing exercise and Conventional stroke physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2023to 18 Jan 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-65 years
- Onset of ischemic stroke in first two week
- First episode of unilateral stroke with hemiparesis during previous 12 months
- Patient with no serious cognitive deficits i-e mini-mental state examination (score >22) ability to understand, perform and follow simple verbal instructions
- Functional ambulation category (FAC) >3
- 6 min walk test distance should be >200 m
Who cannot join
- Known case of cardiopulmonary disease, BP > 180/100 mmHg twice in 24 hours
- Known case of neurological disease other than stroke, Known case of orthopedic disease i-e funnel chest, rib fractures or any other orthopedic deformity
- Medication that would influence metabolic or cardiorespiratory responses to exercise Impaired level of consciousness, Evidence of gross cognitive impairment.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Northwest General Hospital, Peshawar;
Peshawar, Punjab Province, 44000
About this study
Official title: Effect of Resistive Diaphragmatic Breathing Exercise With Pursed Lips Breathing Exercise on Pulmonary Function, Trunk Control and Functional Capacity in Sub-acute Stroke Patients
To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve pulmonary function in sub-acute ischemic stroke, To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve Trunk Control in sub-acute ischemic stroke, To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve Functional Capacity in sub-acute ischemic stroke
- Conditions
- Stroke, Ischemic
- Being tested
- Resistive Diaphragmatic breathing exercise, Diaphragmatic breathing exercise, Conventional stroke physiotherapy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistive Diaphragmatic breathing exerciseOther
- Resistive Diaphragmatic breathing exercise
- Pursed lips breathing exercise
- Conventional stroke physiotherapy
Diaphragmatic breathing exerciseOther
- Diaphragmatic breathing exercise
- Pursed lips breathing exercise
- Conventional stroke physiotherapy
Conventional stroke physiotherapyOther
Conventional stroke physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Active comparator | 1. Resistive Diaphragmatic breathing exercise
2. Pursed lips breathing exercise
3. Conventional stroke physiotherapy Receives: Other: Resistive Diaphragmatic breathing exercise; Other: Diaphragmatic breathing exercise; Other: Conventional stroke physiotherapy |
| Treatment B | Active comparator | 1. Diaphragmatic breathing exercise
2. Pursed lips breathing exercise
3. Conventional stroke physiotherapy Receives: Other: Resistive Diaphragmatic breathing exercise; Other: Diaphragmatic breathing exercise; Other: Conventional stroke physiotherapy |
| Control group | Active comparator | a) Conventional stroke physiotherapy Receives: Other: Resistive Diaphragmatic breathing exercise; Other: Diaphragmatic breathing exercise; Other: Conventional stroke physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary function
The pulmonary functions Spirometer measure can be expressed as Forced Expiratory Volume in 1 second (FEV1) and Force Vital Capacity (FVC) .
Measured: 4 weeks
Trunk Control
Trunk performance and coordination by static and dynamic sitting balance was measured by TIS.TIS comprises 17 items, measures dynamic and static sitting balance and trunk co-ordination. The TIS total score is 0-23 points, higher scores show better performance.
It takes about 6 to 16 minutes in applying TIS
Measured: 4weeks
Functional Capacity
6 MWT is used for functional capacity of participants, by walking for 6 minutes.
Participant walk between the point marked, as numerous periods as can in 6 minutes.
The 6-minute walk (6mw) test is a reliable and valid measure of for assessing functional capacity.
Measured: 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Sep 2023
- Primary completion15 Jan 2024
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Razzaq, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326801
- Sponsor's protocol ID
- REC/014220 Muhammad Iqbal
- Status last verified
- Mar 2024
- First submitted
- 18 Jan 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resistive Diaphragmatic Breathing Exercise With Pursed Lips Breathing Exercise on Pulmonary Function, Trunk Control and Functional Capacity in Sub-acute Stroke Patients
- ClinicalTrials.gov ID
- NCT06326801
- Acronym / sponsor ID
- REC/014220 Muhammad Iqbal
- Conditions
- Stroke, Ischemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 22 Mar 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.
To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve pulmonary function in sub-acute ischemic stroke, To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve Trunk Control in sub-acute ischemic stroke, To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve Functional Capacity in sub-acute ischemic stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Active comparator | Other: Resistive Diaphragmatic breathing exercise, Other: Diaphragmatic breathing exercise, Other: Conventional stroke physiotherapy1. Resistive Diaphragmatic breathing exercise 2. Pursed lips breathing exercise 3. Conventional stroke physiotherapy |
| Treatment B | Active comparator | Other: Resistive Diaphragmatic breathing exercise, Other: Diaphragmatic breathing exercise, Other: Conventional stroke physiotherapy1. Diaphragmatic breathing exercise 2. Pursed lips breathing exercise 3. Conventional stroke physiotherapy |
| Control group | Active comparator | Other: Resistive Diaphragmatic breathing exercise, Other: Diaphragmatic breathing exercise, Other: Conventional stroke physiotherapya) Conventional stroke physiotherapy |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 40-65 years
- Onset of ischemic stroke in first two week
- First episode of unilateral stroke with hemiparesis during previous 12 months
- Patient with no serious cognitive deficits i-e mini-mental state examination (score >22) ability to understand, perform and follow simple verbal instructions
- Functional ambulation category (FAC) >3
Key exclusion criteria (3 listed)
- Known case of cardiopulmonary disease, BP > 180/100 mmHg twice in 24 hours
- Known case of neurological disease other than stroke, Known case of orthopedic disease i-e funnel chest, rib fractures or any other orthopedic deformity
- Medication that would influence metabolic or cardiorespiratory responses to exercise Impaired level of consciousness, Evidence of gross cognitive impairment.
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 |
|---|---|---|
| Resistive Diaphragmatic breathing exercise1. Resistive Diaphragmatic breathing exercise 2. Pursed lips breathing exercise 3. Conventional stroke physiotherapy | Other | Control group, Treatment A, Treatment B |
| Diaphragmatic breathing exercise1. Diaphragmatic breathing exercise 2. Pursed lips breathing exercise 3. Conventional stroke physiotherapy | Other | Control group, Treatment A, Treatment B |
| Conventional stroke physiotherapyConventional stroke physiotherapy | Other | Control group, Treatment A, Treatment B |
Primary outcome
pulmonary function
Time frame: 4 weeks
The pulmonary functions Spirometer measure can be expressed as Forced Expiratory Volume in 1 second (FEV1) and Force Vital Capacity (FVC) .
Trunk Control
Time frame: 4weeks
Trunk performance and coordination by static and dynamic sitting balance was measured by TIS.TIS comprises 17 items, measures dynamic and static sitting balance and trunk co-ordination. The TIS total score is 0-23 points, higher scores show better performance. It takes about 6 to 16 minutes in applying TIS
Functional Capacity
Time frame: 4weeks
6 MWT is used for functional capacity of participants, by walking for 6 minutes. Participant walk between the point marked, as numerous periods as can in 6 minutes. The 6-minute walk (6mw) test is a reliable and valid measure of for assessing functional capacity.
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 22 Mar 2024.
- 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.
Maria Razzaq, MS 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 Resistive Diaphragmatic breathing exercise, Diaphragmatic breathing exercise and Conventional stroke physiotherapy in people with Stroke, Ischemic, 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 3 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 22 Mar 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?
pulmonary function (time frame: 4 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?
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 22 Mar 2024.