Determining the Standard Timing for Inspiratory Muscle Training in Stroke Patients and 6 Months Follow-up
Primary Purpose
Stroke, Complication, Respiratory Complication
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
inspiratory muscle training
sham intervention
Sponsored by

About this trial
This is an interventional treatment trial for Stroke, Complication focused on measuring Breathing exercises, Cerebrovascular disease, Muscle strength, Rehabilitation, Stroke
Eligibility Criteria
Inclusion Criteria:
- Ischemic/ hemorrhagic stroke
- Stroke duration> 3 months
- Age> 18 years old
- Baseline maximal inspiratory pressure below 80 cmH2O
Exclusion Criteria:
- Cognitive deficiency
- Facial paralysis
- Chronic obstructive pulmonary disease
- Congestive heart disease
- Myocardial infarction in last three months
- Angina pectoris
Sites / Locations
- Istanbul Physical Medicine Rehabilitation Traning and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
intervention 1
intervention 2
control group
Arm Description
in this group patients will get 4 week of inspiratory muscle training exercise 30 minutes every weekday ( 15 minutes of two session in each day)
in this group patients will get 8 week of inspiratory muscle training exercise 30 minutes every weekday ( 15 minutes of two session in each day)
this group will get sham intervention with 0 to 5 cmH2O resistance
Outcomes
Primary Outcome Measures
The change in maximal inspiratory pressure
Measured with MicroRPM (respiratory pressure meter) pressurometer device orally
Secondary Outcome Measures
The change in walking capacity
The change in walking capacity wil be measured with Six Minute Walk Test
Pneumonia incidence
Number of participants with Pneumonia will be determined at week 24
Full Information
NCT ID
NCT04397133
First Posted
November 11, 2019
Last Updated
May 22, 2022
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Collaborators
Istanbul Saglik Bilimleri University
1. Study Identification
Unique Protocol Identification Number
NCT04397133
Brief Title
Determining the Standard Timing for Inspiratory Muscle Training in Stroke Patients and 6 Months Follow-up
Official Title
Determining the Standard Timing for Inspiratory Muscle Training in Stroke Patients and 6 Months Follow-up: A Single-blinded Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 23, 2019 (Actual)
Primary Completion Date
April 14, 2022 (Actual)
Study Completion Date
May 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Collaborators
Istanbul Saglik Bilimleri University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The first aim of this study is if there is any difference between 4 or 8 weeks of inspiratory muscle training ( IMT ) exercises groups and control groups in stroke survivors. The secondary aims of this study is if there is any difference in walking capacity (in 8th, 12th, 24th weeks) and pulmonary complications (pneumonia incidences) in long term follow-ups (6 months) in these aforementioned groups
Detailed Description
Stroke is one of the leading causes of death and disability. It is not only because of loss of extremity motions but also loss of inspiratory muscle strength. In this study we aimed to determine the optimum duration for inspiratory muscle training exercises for stroke survivors since there is not enough data about it in the literature.
The study will include at least 54 patients in total and 18 in each groups ( two intervention and one control) . The patients will be evaluated for angina, chronic obstructive pulmonary disease, congestive heart disease; in these conditions the patients will be excluded from the study. Also in first examinations we will evaluate the maximal inspiratory pressure (MIP) of patients, of them the ones with MIP measurements above 80 mmH2O will also be excluded since it is the expected value in normal people.
After admission and randomizing the patients, baseline measurements of MIP, 6-minutes walking test will be done. In intervention groups the patients will get 30 minutes of inspiratory muscle training exercises ( 15 minutes of two session each day) with threshold IMT device every weekday. And in control group, the patients will get sham intervention for 8 weeks. The MIP and 6-minutes walking test will be done in 8th,12th and 24th weeks. And also in 24th week we will record the pneumonia incidence if occured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Complication, Respiratory Complication
Keywords
Breathing exercises, Cerebrovascular disease, Muscle strength, Rehabilitation, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
three armed study with two interventions and one control group intervention group 1: inspiratory muscle training applied for 4 week intervention group 2: inspiratory muscle training applied for 8 week control group : will get sham intervention
Masking
InvestigatorOutcomes Assessor
Masking Description
the assessor who will investigate the results and the investigator who will perform the MIP and 6-minutes walking test will be blinded to the randomization
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention 1
Arm Type
Experimental
Arm Description
in this group patients will get 4 week of inspiratory muscle training exercise 30 minutes every weekday ( 15 minutes of two session in each day)
Arm Title
intervention 2
Arm Type
Experimental
Arm Description
in this group patients will get 8 week of inspiratory muscle training exercise 30 minutes every weekday ( 15 minutes of two session in each day)
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
this group will get sham intervention with 0 to 5 cmH2O resistance
Intervention Type
Other
Intervention Name(s)
inspiratory muscle training
Intervention Description
inspiratory muscle training will be done with Philips Respironics Threshold IMT device starting with resistance of % 50 of MIP value
Intervention Type
Other
Intervention Name(s)
sham intervention
Intervention Description
in these group the patients will get sham intervention with Philips Respironics Threshold IMT device
Primary Outcome Measure Information:
Title
The change in maximal inspiratory pressure
Description
Measured with MicroRPM (respiratory pressure meter) pressurometer device orally
Time Frame
Baseline and week 8,12, 24
Secondary Outcome Measure Information:
Title
The change in walking capacity
Description
The change in walking capacity wil be measured with Six Minute Walk Test
Time Frame
Baseline and week 8,12, 24
Title
Pneumonia incidence
Description
Number of participants with Pneumonia will be determined at week 24
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ischemic/ hemorrhagic stroke
Stroke duration> 3 months
Age> 18 years old
Baseline maximal inspiratory pressure below 80 cmH2O
Exclusion Criteria:
Cognitive deficiency
Facial paralysis
Chronic obstructive pulmonary disease
Congestive heart disease
Myocardial infarction in last three months
Angina pectoris
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunus Emre Doğan, MD
Organizational Affiliation
Istanbul Physical Medicine Rehabilitation Traning and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Burak Kütük, MD
Organizational Affiliation
Istanbul Physical Medicine Rehabilitation Traning and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Physical Medicine Rehabilitation Traning and Research Hospital
City
Istanbul
ZIP/Postal Code
34100
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
22568454
Citation
Pollock RD, Rafferty GF, Moxham J, Kalra L. Respiratory muscle strength and training in stroke and neurology: a systematic review. Int J Stroke. 2013 Feb;8(2):124-30. doi: 10.1111/j.1747-4949.2012.00811.x. Epub 2012 May 9.
Results Reference
background
PubMed Identifier
21272713
Citation
Britto 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.
Results Reference
background
PubMed Identifier
27271373
Citation
Guillen-Sola A, Messagi Sartor M, Bofill Soler N, Duarte E, Barrera MC, Marco E. Respiratory muscle strength training and neuromuscular electrical stimulation in subacute dysphagic stroke patients: a randomized controlled trial. Clin Rehabil. 2017 Jun;31(6):761-771. doi: 10.1177/0269215516652446. Epub 2016 Jun 7.
Results Reference
background
PubMed Identifier
21876848
Citation
Billinger SA, Coughenour E, Mackay-Lyons MJ, Ivey FM. Reduced cardiorespiratory fitness after stroke: biological consequences and exercise-induced adaptations. Stroke Res Treat. 2012;2012:959120. doi: 10.1155/2012/959120. Epub 2011 Aug 14.
Results Reference
background
PubMed Identifier
20156979
Citation
Sutbeyaz ST, Koseoglu F, Inan L, Coskun O. Respiratory muscle training improves cardiopulmonary function and exercise tolerance in subjects with subacute stroke: a randomized controlled trial. Clin Rehabil. 2010 Mar;24(3):240-50. doi: 10.1177/0269215509358932. Epub 2010 Feb 15.
Results Reference
background
PubMed Identifier
12601102
Citation
Katzan IL, Cebul RD, Husak SH, Dawson NV, Baker DW. The effect of pneumonia on mortality among patients hospitalized for acute stroke. Neurology. 2003 Feb 25;60(4):620-5. doi: 10.1212/01.wnl.0000046586.38284.60.
Results Reference
background
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Determining the Standard Timing for Inspiratory Muscle Training in Stroke Patients and 6 Months Follow-up
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