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AzTrials

StrokeNCT05678816

Effect Of Breather On Pulmonary And Physical Function In Post Stroke Survivors

A study testing BREATHER and physiotherapy prgramme for rehabilitation of stroke patients in people with Stroke, run by Cairo University at 2 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Stroke is the second major cause of death and disability worldwide with over 13 million new cases annually. Egypt, a low-middle-income country, is the most populated nation in the Middle East with a high overall crude prevalence rate of stroke (963/100,000 inhabitants), accounting for 6.4% of all deaths and the… Read more about this study

Who is it for?
Ages 40 to 60 years
Conditions the study is for
Stroke
What is being tested?
BREATHER and physiotherapy prgramme for rehabilitation of stroke patients
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesEgypt
Study dates
15 Sep 2022to 30 Dec 2022
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Sixty patients were selected from both sexes.Their age were from 50 to 65 years old
  • All patients were medically stable.
  • All patients had the ability to understand and follow simple verbal instructions.
  • All patients were in subacute stage from about 3 to 6 months post lesion.

Who cannot join

  • Patients with severe acute illness.
  • Chronic unstable pulmonary and/or cardiac disease.
  • Impaired level of consciousness and evidence of gross cognitive problems.
  • Patients undergoes chemotherapy.
  • Active hemoptysis, untreated pneumothorax, recent esophageal surgery.
  • Recent oral, facial or skull trauma / surgery, acute sinusitis, epistaxis.
Show all 9Show fewer
  • Smokers.
  • Any oral dysfunction that interfere with using the breather.
  • Un controlled BP systole more than180 or diastole more than 90.

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites

  • Cairo University

    Giza

  • Faculty of Phsical Therapy

    Giza

Other trials in Egypt

About this study

Stroke is the second major cause of death and disability worldwide with over 13 million new cases annually.

Egypt, a low-middle-income country, is the most populated nation in the Middle East with a high overall crude prevalence rate of stroke (963/100,000 inhabitants), accounting for 6.4% of all deaths and the incidence of stroke annually is approximately 150,000-210,000.

Read more

Stroke has a direct impact on health systems, resulting in high costs, and is also considered a global public health problem due to serious disabilities, functional limitations and compromised quality of life (QoL).

The Breather a drug-free, evidence-based inspiratory/expiratory respiratory muscle training (RMT) device used by Dysphagia, COPD, CHF, Parkinson's, and neuromuscular disease patients, as well as children 4+ and adults interested in healthy aging.

Read the detailed description

Stroke is a leading cause of death and disability in globally and particularly in low and middle-income countries, and this burden is increasing.

The expected spontaneous biological recovery follows the "proportional recovery rule" - most patients recover 70% of their impaired motor or verbal function during the first three months after stroke however, 90% of them have residual deficit.

Stroke patients may experience a reduction of up to 50% in respiratory function when compared to age- and gender-matched norms. The reduction in respiratory function can lead to decreased endurance, dyspnea and increased sedentary behaviour, as well as an elevated risk of recurrent stroke. The reduction in respiratory function may also cause aspiration, leading to pneumonia. Previous research showed that pneumonia was an independent risk factor for mortality and a poor prognosis in stroke patients. Research also showed that a reduction in respiratory muscle and abdominal muscle strength contributed to pulmonary and respiratory dysfunction following a stroke.

After a stroke, the respiratory center and related motor pathways can directly decrease respiratory muscle strength and subsequently induce a change in breathing patterns. As a result, pneumonia, pulmonary ventilation disorders, lung injury, lung ischemia reperfusion injury, decreased pulmonary compliance, abnormal posture, and obstructive sleep apnea can occur following a stroke. Thus, pulmonary rehabilitation is critical to reducing these complications. The main forms of pulmonary rehabilitation include exercise training, respiratory muscle training, oxygen therapy, noninvasive ventilation, nutrition support, social psychological support, and health education.

The inspiratory muscles can be specifically trained, with improvement of both muscle strength and endurance by using the breather device.

As result utilizing the breather may help stroke patients recover quickly and avoid respiratory complication.

Conditions
Stroke
Being tested
BREATHER, physiotherapy prgramme for rehabilitation of stroke patients
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BREATHERDevice

    respiratory muscle trainer used to strength inspiratory an expiratory muscles through breathing in and out against aresistence which is determined individually according to each patient.

  • physiotherapy prgramme for rehabilitation of stroke patientsOther

    physiotherapy prgramme for rehabilitation of stroke patients which include:

    • Passive stretching exercise, strengthening exercise.
    • Postural control and balance exercise from different positions as quadruped, kneeling, sitting and standing.
    • Gait training.
Study groups in NCT05678816
Study groupRoleWhat they receive
BREATHER GROUPExperimental1)respiratory muscle training for inspiratory and expiratory muscles by the breather device 2)physiotherapy prgramme for stroke rehabilitation which include: * Passive stretching exercise, strengthening exercise. * Postural control and balance exercise from different positions as quadruped, kneeling, sitting and standing. * Gait training.
Receives: Device: BREATHER; Other: physiotherapy prgramme for rehabilitation of stroke patients
CONTROLOtherphysiotherapy prgramme for stroke rehabilitation which include: * Passive stretching exercise, strengthening exercise. * Postural control and balance exercise from different positions as quadruped, kneeling, sitting and standing. * Gait training.
Receives: Other: physiotherapy prgramme for rehabilitation of stroke patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. forced expiratory volium in first second FEV1 in litres

    fifty patients will be assessed for their FEV1 using spirometer

    Measured: 6 weeks

  2. foced vital capacity FVC in litres

    fifty patients will be assessed for their FVC using spirometer

    Measured: 6 weeks

  3. peak inspiratory flow PIF in litres per second

    fifty patients will be assessed for their PIF using spirometer

    Measured: 6 weeks

  4. peak expiratory flow PEF in litres per second

    fifty patients will be assessed for their PEF using spirometer

    Measured: 6 weeks

Secondary outcomes (4)

  1. Chest expansion in centimeters using tape measurement

    sixty patient willl be assessed for thier chest expansion tape measurement will be used to assess difference in circumference of chest between full expiration and full inspiration.

    Measured: 6 weeks

  2. oxygen saturation in percentage using spirometer

    spirometer will be used to indirectly measure saturation of blood by oxygen.

    Measured: 6 weeks

  3. six minute walk distance in metersused to assess functional capacity of patients

    the distance walked within six minute will be calculated for every patient

    Measured: 6 weeks

  4. stroke impact scale to assess the effect of stroke on different domains astanderdized score ranging from 0 to 100 is calculated for all domains with higher score indicating a higher quality of life

    The stroke impact scale was developed from the perspectives of both patients and care givers. The current stroke impact scale 3.0 is a revised version of the original SIS , with established reliability and validity. The SIS 3.0 contains 59 items measuring eight domains, including strength, hand function, activity of daily living, mobility, communication, emotion, memory/thinking, and participation, with a single item assessing perceived overall recovery from stroke

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2023
  2. Study start15 Sep 2022
  3. Primary completion15 Dec 2022
  4. Study completion30 Dec 2022

Resources

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05678816
Sponsor's protocol ID
P.T.REC/012/003961
Status last verified
Jan 2023
First submitted
4 Dec 2022
Last updated
10 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lindsay MP, Norrving B, Sacco RL, Brainin M, Hacke W, Martins S, Pandian J, Feigin V. World Stroke Organization (WSO): Global Stroke Fact Sheet 2019. Int J Stroke. 2019 Oct;14(8):806-817. doi: 10.1177/1747493019881353. No abstract available.

    PubMed 31658892

  • Aref H, Zakaria M, Shokri H, Roushdy T, El Basiouny A, El Nahas N. Changing the Landscape of Stroke in Egypt. Cerebrovasc Dis Extra. 2021;11(3):155-159. doi: 10.1159/000521271. Epub 2021 Dec 3.

    PubMed 34864736

  • Krishnamurthi RV, Ikeda T, Feigin VL. Global, Regional and Country-Specific Burden of Ischaemic Stroke, Intracerebral Haemorrhage and Subarachnoid Haemorrhage: A Systematic Analysis of the Global Burden of Disease Study 2017. Neuroepidemiology. 2020;54(2):171-179. doi: 10.1159/000506396. Epub 2020 Feb 20.

    PubMed 32079017

  • Gungen BD, Tunc A, Aras YG, Gundogdu AA, Gungen AC, Bal S. Predictors of intensive care unit admission and mortality in patients with ischemic stroke: investigating the effects of a pulmonary rehabilitation program. BMC Neurol. 2017 Jul 11;17(1):132. doi: 10.1186/s12883-017-0912-4.

    PubMed 28693521

Questions about this trial

What is this clinical trial studying?

A study testing BREATHER and physiotherapy prgramme for rehabilitation of stroke patients in people with Stroke, run by Cairo University at 2 sites in Egypt.

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 4 inclusion and 9 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 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. 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?

forced expiratory volium in first second FEV1 in litres (time frame: 6 weeks). 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 NCT05678816, which also lists 4 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 10 Jan 2023.

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