Respiratory Complication, Stroke, Complication
Conditions
Keywords
Breathing exercises, Cerebrovascular disease, Muscle strength, Rehabilitation, Stroke
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.
Interventions
OTHERinspiratory muscle training
inspiratory muscle training will be done with Philips Respironics Threshold IMT device starting with resistance of % 50 of MIP value
OTHERsham intervention
in these group the patients will get sham intervention with Philips Respironics Threshold IMT device
Sponsors
Istanbul Saglik Bilimleri University
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes 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
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in maximal inspiratory pressure | Baseline and week 8,12, 24 | Measured with MicroRPM (respiratory pressure meter) pressurometer device orally |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change in walking capacity | Baseline and week 8,12, 24 | The change in walking capacity wil be measured with Six Minute Walk Test |
| Pneumonia incidence | Week 24 | Number of participants with Pneumonia will be determined at week 24 |
Countries
Turkey (Türkiye)
Outcome results
None listed