The Optimal Treatment Duration for Inspiratory Muscle Strengthening Exercises in Stroke Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Optimal Treatment Duration for Inspiratory Muscle Strengthening Exercises in Stroke Patients: A Double-blind Randomised Controlled Trial

Conditions
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Stroke, Complication, Respiratory Complication

Intervention / Treatment
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* Other: inspiratory muscle training
* Other: sham intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention 1<br>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) | Other: inspiratory muscle training<br>* inspiratory muscle training will be done with Philips Respironics Threshold IMT device starting with resistance of % 50 of MIP value<br>|
| Experimental: intervention 2<br>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) | Other: inspiratory muscle training<br>* inspiratory muscle training will be done with Philips Respironics Threshold IMT device starting with resistance of % 50 of MIP value<br>|
| Sham Comparator: control group<br>this group will get sham intervention with 0 to 5 cmH2O resistance | Other: sham intervention<br>* in these group the patients will get sham intervention with Philips Respironics Threshold IMT device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in maximal inspiratory pressure | Measured with MicroRPM (respiratory pressure meter) pressurometer device orally | Baseline and week 8,12, 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in walking capacity | The change in walking capacity wil be measured with Six Minute Walk Test | Baseline and week 8,12, 24 | 
| Pneumonia incidence | Number of participants with Pneumonia will be determined at week 24 | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breathing exercises, Cerebrovascular disease, Muscle strength, Rehabilitation, Stroke