NCT03195907

Brief Summary

This study evaluates the predictors of intensive care unit admission and mortality among stroke patients and the effects of pulmonary physiotherapy on these stroke patients. One-hundred patients participated in the pulmonary rehabilitation program and 81 patients served as a control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
Last Updated

June 22, 2017

Status Verified

June 1, 2017

Enrollment Period

11 months

First QC Date

June 20, 2017

Last Update Submit

June 21, 2017

Conditions

Keywords

StrokeMortalityIntensive care unitPulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Intensive care unit admission

    Patients who require mechanical ventilation were admitted to the neurological intensive care unit

    3 months

Secondary Outcomes (4)

  • Mortality rates

    3 months

  • Assessment of stroke severity

    3 months

  • Assessment of functional disability

    3 months

  • Pneumonia onset

    3 months

Study Arms (2)

PPT group

Those participated in pulmonary rehabilitation program

Other: Pulmonary physiotherapy

Control group

Those served as control group

Interventions

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who were admitted to the neurology clinic stroke unit or the neurological intensive care unit

You may qualify if:

  • acute ischemic stroke confirmed by computed tomography or a diffusion-weighed magnetic resonance imaging scan,
  • aged \> 40 years,
  • ability to understand and follow simple verbal instructions,
  • modified Rankin scale score \> 2,
  • National Institute of Health Stroke Scale score \> 0,
  • no unrestricted movement of the lips,
  • no receptive aphasia and no history of thoracic or abdominal surgery.

You may not qualify if:

  • blood pressure \>180/100 mm Hg more than twice in 24 h;
  • significant pulmonary disease, angina, myocardial infarction or acute heart failure within three months;
  • neurological conditions other than stroke;
  • presence of a severe visual disability and visual field defects;
  • receiving medications that would influence the metabolic or cardiorespiratory responses to exercise;
  • inability to perform the tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University

Sakarya, Serdivan, 54050, Turkey (Türkiye)

Location

Related Publications (6)

  • Seo K, Hwan PS, Park K. The effects of inspiratory diaphragm breathing exercise and expiratory pursed-lip breathing exercise on chronic stroke patients' respiratory muscle activation. J Phys Ther Sci. 2017 Mar;29(3):465-469. doi: 10.1589/jpts.29.465. Epub 2017 Mar 22.

  • Lan MY, Wu SJ, Chang YY, Chen WH, Lai SL, Liu JS. Neurologic and non-neurologic predictors of mortality in ischemic stroke patients admitted to the intensive care unit. J Formos Med Assoc. 2006 Aug;105(8):653-8. doi: 10.1016/S0929-6646(09)60164-9.

  • Grube MM, Koennecke HC, Walter G, Meisel A, Sobesky J, Nolte CH, Wellwood I, Heuschmann PU; Berlin Stroke Register (BSR). Influence of acute complications on outcome 3 months after ischemic stroke. PLoS One. 2013 Sep 24;8(9):e75719. doi: 10.1371/journal.pone.0075719. eCollection 2013.

  • Kim J, Park JH, Yim J. Effects of respiratory muscle and endurance training using an individualized training device on the pulmonary function and exercise capacity in stroke patients. Med Sci Monit. 2014 Dec 5;20:2543-9. doi: 10.12659/MSM.891112.

  • Katz-Leurer M, Shochina M, Carmeli E, Friedlander Y. The influence of early aerobic training on the functional capacity in patients with cerebrovascular accident at the subacute stage. Arch Phys Med Rehabil. 2003 Nov;84(11):1609-14. doi: 10.1053/s0003-9993(03)00344-7.

  • 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.

MeSH Terms

Conditions

Ischemic StrokeStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Abdulkadir TUNÇ, MD

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Neurologist

Study Record Dates

First Submitted

June 20, 2017

First Posted

June 22, 2017

Study Start

February 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

June 22, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

The datasets during and/or analysed during the current study available from the corresponding author on reasonable request.

Locations