Stroke (CVA) or TIANCT04636658
Effects of Resistive Diaphragmatic Training on Chronic Stroke
A study testing Incentive spirometer training and diaphragmatic resistance exercises in people with Stroke (CVA) or TIA, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of resistive diaphragmatic training on pulmonary function of chronic stroke patients. And also assessing their compromised respiratory functions Read more about this study
- Who is it for?
- Ages 40 to 50 years
- Conditions the study is for
- Stroke (CVA) or TIA
- What is being tested?
- Incentive spirometer training and diaphragmatic resistance exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2020to 1 Sep 2020
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age limit 40-50yrs both genders.
- Stroke patients with compromised pulmonary functions.
- Chronic stroke patients with impaired Breathing
Who cannot join
- Patients having any systemic illness
- Patients who have a damage accompanying orthopedic disease such as thoracic deformation or rib fracture.
- Patients with stroke (less than 6 months duration)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Resistive Diaphragmatic Training on Pulmonary Functions in Patients With Chronic Stroke
To determine the effects of resistive diaphragmatic training on pulmonary function of chronic stroke patients. And also assessing their compromised respiratory functions
Read the detailed description
This study is to examine the effects of Diaphragmatic breathing exercises with resistance and Digital spirometer training for improving pulmonary functions in chronic stroke patients. Diaphragmatic Resistance training is based on the same principal as for the any other Skeletal Muscle training. The selection of 20 subjects divided equally and placed into an experimental group and a control group and the interventions would applied three times per week for 4 weeks. In each session, both groups receive Digital spirometer training for 15 minutes. In addition, experimental group receive diaphragm breathing exercises with resistance for 30 minutes. Resistance is Applied through Different thera bands and then performing the Breathing Exercises. First of all resistance applied through yellow band(1-6 pounds of resistance) and then red, Green and black which give (4-18 Pounds of resistance) The patient is asked to breath in deeply and slowly while not to move upper chest .Weight increased weekly as per patient's tolerance. Further Digital spirometer training Perform to determine the Pulmonary Functions FVC,FEV1,FVC/FEV1,PEF,VC. in both Control and Experimental Groups
- Conditions
- Stroke (CVA) or TIA
- Being tested
- Incentive spirometer training, diaphragmatic resistance exercises
- Keywords
- stroke, resistive diaphragmatic training, pulmonary function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentive spirometer trainingOther
Incentive spirometer training 5 sessions a week, each session of 15 minutes, for 4 weeks
diaphragmatic resistance exercisesOther
Incentive spirometer with diaphragmatic resistance exercises. Resistance is applied through the different Thera bands and then performing the pursed lip breathing exercise. Resistance increased weekly as per tolerance by the patient.
Digital spirometer training for 15 minutes. diaphragm breathing exercises with resistance for 30 minutes. 5 sessions a week, for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Incentive spirometer training | Active comparator | Incentive spirometer training Receives: Other: Incentive spirometer training |
| diaphragmatic resistance exercises | Experimental | Incentive spirometer training with diaphragm breathing with resistance exercises. Resistance is applied through the different Thera bands and then performing the pursed lip breathing exercise. Resistance increased weekly as per tolerance by the patient Receives: Other: diaphragmatic resistance exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1
FEV1 is the amount of air you can force from your lungs in one second. It's measured during a spirometry test, also known as a pulmonary function test, which involves forcefully breathing out into a mouthpiece connected to a spirometer machine.
Measured: 4th week
FVC
Forced vital capacity (FVC) is the total amount of air exhaled during the FEV test. Forced expiratory volume and forced vital capacity are lung function tests that are measured during spirometry. Forced expiratory volume is the most important measurement of lung function.
Measured: 4th week
Oxygen level in blood
Pulse oximetry is a test used to measure the oxygen level (oxygen saturation) of the blood
Measured: 4th week
Heart Rate
Pulse oximetry is a test used to measure the heart rate
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start15 Feb 2020
- Primary completion20 Aug 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Stroke (CVA) or TIAStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anam Aftab, Phd*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636658
- Sponsor's protocol ID
- REC/00237 Bushra Mushtaq
- Status last verified
- Nov 2020
- First submitted
- 3 Oct 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Katan M, Luft A. Global Burden of Stroke. Semin Neurol. 2018 Apr;38(2):208-211. doi: 10.1055/s-0038-1649503. Epub 2018 May 23.
PubMed 29791947Di Carlo A. Human and economic burden of stroke. Age Ageing. 2009 Jan;38(1):4-5. doi: 10.1093/ageing/afn282. No abstract available.
PubMed 19141505Hochstenbach J, Donders R, Mulder T, Van Limbeek J, Schoonderwaldt H. Long-term outcome after stroke: a disability-orientated approach. Int J Rehabil Res. 1996 Sep;19(3):189-200. doi: 10.1097/00004356-199609000-00001. No abstract available.
PubMed 8910122Johnson W, Onuma O, Owolabi M, Sachdev S. Stroke: a global response is needed. Bull World Health Organ. 2016 Sep 1;94(9):634-634A. doi: 10.2471/BLT.16.181636. No abstract available.
PubMed 27708464Feigin VL, Krishnamurthi RV, Parmar P, Norrving B, Mensah GA, Bennett DA, Barker-Collo S, Moran AE, Sacco RL, Truelsen T, Davis S, Pandian JD, Naghavi M, Forouzanfar MH, Nguyen G, Johnson CO, Vos T, Meretoja A, Murray CJ, Roth GA; GBD 2013 Writing Group; GBD 2013 Stroke Panel Experts Group. Update on the Global Burden of Ischemic and Hemorrhagic Stroke in 1990-2013: The GBD 2013 Study. Neuroepidemiology. 2015;45(3):161-76. doi: 10.1159/000441085. Epub 2015 Oct 28.
PubMed 26505981Menezes KK, Nascimento LR, Ada L, Polese JC, Avelino PR, Teixeira-Salmela LF. Respiratory muscle training increases respiratory muscle strength and reduces respiratory complications after stroke: a systematic review. J Physiother. 2016 Jul;62(3):138-44. doi: 10.1016/j.jphys.2016.05.014. Epub 2016 Jun 16.
PubMed 27320833Cabral EEA, Resqueti VR, Lima INDF, Gualdi LP, Aliverti A, Fregonezi GAF. Effects of positive expiratory pressure on chest wall volumes in subjects with stroke compared to healthy controls: a case-control study. Braz J Phys Ther. 2017 Nov-Dec;21(6):416-424. doi: 10.1016/j.bjpt.2017.06.006. Epub 2017 Jul 8.
PubMed 28736210Menezes KK, Nascimento LR, Avelino PR, Alvarenga MTM, Teixeira-Salmela LF. Efficacy of Interventions to Improve Respiratory Function After Stroke. Respir Care. 2018 Jul;63(7):920-933. doi: 10.4187/respcare.06000. Epub 2018 May 29.
PubMed 29844210Lista Paz A, Gonzalez Doniz L, Ortigueira Garcia S, Saleta Canosa JL, Moreno Couto C. Respiratory Muscle Strength in Chronic Stroke Survivors and Its Relation With the 6-Minute Walk Test. Arch Phys Med Rehabil. 2016 Feb;97(2):266-72. doi: 10.1016/j.apmr.2015.10.089. Epub 2015 Oct 28.
PubMed 26519610Kashihara H, Haruna Y, Suzuki Y, Kawakubo K, Takenaka K, Bonde-Petersen F, Gunji A. Effects of mild supine exercise during 20 days bed rest on maximal oxygen uptake rate in young humans. Acta Physiol Scand Suppl. 1994;616:19-26.
PubMed 8042521Lee DK, Jeong HJ, Lee JS. Effect of respiratory exercise on pulmonary function, balance, and gait in patients with chronic stroke. J Phys Ther Sci. 2018 Aug;30(8):984-987. doi: 10.1589/jpts.30.984. Epub 2018 Jul 24.
PubMed 30154586Oh DS, Park SE. The effect of lumbar stabilization exercise on the pulmonary function of stroke patients. J Phys Ther Sci. 2016 Jun;28(6):1896-900. doi: 10.1589/jpts.28.1896. Epub 2016 Jun 28.
PubMed 27390442Jung JH, Shim JM, Kwon HY, Kim HR, Kim BI. Effects of Abdominal Stimulation during Inspiratory Muscle Training on Respiratory Function of Chronic Stroke Patients. J Phys Ther Sci. 2014 Jan;26(1):73-6. doi: 10.1589/jpts.26.73. Epub 2014 Feb 6.
PubMed 24567679Britto RR, Rezende NR, Marinho KC, Torres JL, Parreira VF, Teixeira-Salmela LF. Inspiratory muscular training in chronic stroke survivors: a randomized controlled trial. Arch Phys Med Rehabil. 2011 Feb;92(2):184-90. doi: 10.1016/j.apmr.2010.09.029.
PubMed 21272713Song GB, Park EC. Effects of chest resistance exercise and chest expansion exercise on stroke patients' respiratory function and trunk control ability. J Phys Ther Sci. 2015 Jun;27(6):1655-8. doi: 10.1589/jpts.27.1655. Epub 2015 Jun 30.
PubMed 26180292
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistive Diaphragmatic Training on Pulmonary Functions in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT04636658
- Acronym / sponsor ID
- REC/00237 Bushra Mushtaq
- Conditions
- Stroke (CVA) or TIA
- Keywords
- stroke, resistive diaphragmatic training, pulmonary function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 19 Nov 2020 (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 the effects of resistive diaphragmatic training on pulmonary function of chronic stroke patients. And also assessing their compromised respiratory functions
Detailed description
This study is to examine the effects of Diaphragmatic breathing exercises with resistance and Digital spirometer training for improving pulmonary functions in chronic stroke patients. Diaphragmatic Resistance training is based on the same principal as for the any other Skeletal Muscle training. The selection of 20 subjects divided equally and placed into an experimental group and a control group and the interventions would applied three times per week for 4 weeks. In each session, both groups receive Digital spirometer training for 15 minutes. In addition, experimental group receive diaphragm breathing exercises with resistance for 30 minutes. Resistance is Applied through Different thera bands and then performing the Breathing Exercises. First of all resistance applied through yellow band(1-6 pounds of resistance) and then red, Green and black which give (4-18 Pounds of resistance) The patient is asked to breath in deeply and slowly while not to move upper chest .Weight increased weekly as per patient's tolerance. Further Digital spirometer training Perform to determine the Pulmonary Functions FVC,FEV1,FVC/FEV1,PEF,VC. in both Control and Experimental Groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incentive spirometer training | Active comparator | Other: Incentive spirometer trainingIncentive spirometer training |
| diaphragmatic resistance exercises | Experimental | Other: diaphragmatic resistance exercisesIncentive spirometer training with diaphragm breathing with resistance exercises. Resistance is applied through the different Thera bands and then performing the pursed lip breathing exercise. Resistance increased weekly as per tolerance by the patient |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age limit 40-50yrs both genders.
- Stroke patients with compromised pulmonary functions.
- Chronic stroke patients with impaired Breathing
Key exclusion criteria (3 listed)
- Patients having any systemic illness
- Patients who have a damage accompanying orthopedic disease such as thoracic deformation or rib fracture.
- Patients with stroke (less than 6 months duration)
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 |
|---|---|---|
| Incentive spirometer trainingIncentive spirometer training 5 sessions a week, each session of 15 minutes, for 4 weeks | Other | Incentive spirometer training |
| diaphragmatic resistance exercisesIncentive spirometer with diaphragmatic resistance exercises. Resistance is applied through the different Thera bands and then performing the pursed lip breathing exercise. Resistance increased weekly as per tolerance by the patient. Digital spirometer training for 15 minutes. diaphragm breathing exercises with resistance for 30 minutes. 5 sessions a week, for 4 weeks | Other | diaphragmatic resistance exercises |
Primary outcome
FEV1
Time frame: 4th week
FEV1 is the amount of air you can force from your lungs in one second. It's measured during a spirometry test, also known as a pulmonary function test, which involves forcefully breathing out into a mouthpiece connected to a spirometer machine.
FVC
Time frame: 4th week
Forced vital capacity (FVC) is the total amount of air exhaled during the FEV test. Forced expiratory volume and forced vital capacity are lung function tests that are measured during spirometry. Forced expiratory volume is the most important measurement of lung function.
Oxygen level in blood
Time frame: 4th week
Pulse oximetry is a test used to measure the oxygen level (oxygen saturation) of the blood
Heart Rate
Time frame: 4th week
Pulse oximetry is a test used to measure the heart rate
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 19 Nov 2020.
- Background: PubMed 29791947Katan M, Luft A. Global Burden of Stroke. Semin Neurol. 2018 Apr;38(2):208-211. doi: 10.1055/s-0038-1649503. Epub 2018 May 23.
- Background: PubMed 19141505Di Carlo A. Human and economic burden of stroke. Age Ageing. 2009 Jan;38(1):4-5. doi: 10.1093/ageing/afn282. No abstract available.
- Background: PubMed 8910122Hochstenbach J, Donders R, Mulder T, Van Limbeek J, Schoonderwaldt H. Long-term outcome after stroke: a disability-orientated approach. Int J Rehabil Res. 1996 Sep;19(3):189-200. doi: 10.1097/00004356-199609000-00001. No abstract available.
- Background: PubMed 27708464Johnson W, Onuma O, Owolabi M, Sachdev S. Stroke: a global response is needed. Bull World Health Organ. 2016 Sep 1;94(9):634-634A. doi: 10.2471/BLT.16.181636. No abstract available.
- Background: PubMed 26505981Feigin VL, Krishnamurthi RV, Parmar P, Norrving B, Mensah GA, Bennett DA, Barker-Collo S, Moran AE, Sacco RL, Truelsen T, Davis S, Pandian JD, Naghavi M, Forouzanfar MH, Nguyen G, Johnson CO, Vos T, Meretoja A, Murray CJ, Roth GA; GBD 2013 Writing Group; GBD 2013 Stroke Panel Experts Group. Update on the Global Burden of Ischemic and Hemorrhagic Stroke in 1990-2013: The GBD 2013 Study. Neuroepidemiology. 2015;45(3):161-76. doi: 10.1159/000441085. Epub 2015 Oct 28.
- Background: PubMed 27320833Menezes KK, Nascimento LR, Ada L, Polese JC, Avelino PR, Teixeira-Salmela LF. Respiratory muscle training increases respiratory muscle strength and reduces respiratory complications after stroke: a systematic review. J Physiother. 2016 Jul;62(3):138-44. doi: 10.1016/j.jphys.2016.05.014. Epub 2016 Jun 16.
- Background: PubMed 28736210Cabral EEA, Resqueti VR, Lima INDF, Gualdi LP, Aliverti A, Fregonezi GAF. Effects of positive expiratory pressure on chest wall volumes in subjects with stroke compared to healthy controls: a case-control study. Braz J Phys Ther. 2017 Nov-Dec;21(6):416-424. doi: 10.1016/j.bjpt.2017.06.006. Epub 2017 Jul 8.
- Background: PubMed 29844210Menezes KK, Nascimento LR, Avelino PR, Alvarenga MTM, Teixeira-Salmela LF. Efficacy of Interventions to Improve Respiratory Function After Stroke. Respir Care. 2018 Jul;63(7):920-933. doi: 10.4187/respcare.06000. Epub 2018 May 29.
- Background: PubMed 26519610Lista Paz A, Gonzalez Doniz L, Ortigueira Garcia S, Saleta Canosa JL, Moreno Couto C. Respiratory Muscle Strength in Chronic Stroke Survivors and Its Relation With the 6-Minute Walk Test. Arch Phys Med Rehabil. 2016 Feb;97(2):266-72. doi: 10.1016/j.apmr.2015.10.089. Epub 2015 Oct 28.
- Background: PubMed 8042521Kashihara H, Haruna Y, Suzuki Y, Kawakubo K, Takenaka K, Bonde-Petersen F, Gunji A. Effects of mild supine exercise during 20 days bed rest on maximal oxygen uptake rate in young humans. Acta Physiol Scand Suppl. 1994;616:19-26.
- Background: PubMed 30154586Lee DK, Jeong HJ, Lee JS. Effect of respiratory exercise on pulmonary function, balance, and gait in patients with chronic stroke. J Phys Ther Sci. 2018 Aug;30(8):984-987. doi: 10.1589/jpts.30.984. Epub 2018 Jul 24.
- Background: PubMed 27390442Oh DS, Park SE. The effect of lumbar stabilization exercise on the pulmonary function of stroke patients. J Phys Ther Sci. 2016 Jun;28(6):1896-900. doi: 10.1589/jpts.28.1896. Epub 2016 Jun 28.
- 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.
Anam Aftab, Phd* 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 Incentive spirometer training and diaphragmatic resistance exercises in people with Stroke (CVA) or TIA, 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 3 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 19 Nov 2020. 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?
FEV1 (time frame: 4th week). The study lists 4 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 NCT04636658, which also lists 21 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 19 Nov 2020.